Appendix C: Robust Study Summary Forms for Key HBCD Studies
Robust Study Summary - Persistence
| Item | Yes | No |
|---|---|---|
| Reference:CMABFRIP. 1996. Hexabromocyclododecane (HBCD): Closed bottle test. Wildlife International Ltd. Project No. 439E-102. Easton (MD): Wildlife International Ltd., November 11, 1996. | ||
| Test Substance(CAS RN and name): 3194-55-6, Cyclododecane, 1,2,5,6,9,10-hexabromo- (hexabromocyclododecane) | ||
| Chemical composition of the substance (including purity, by-products) | X | |
| Method | ||
| References | X | |
| OECD, EU, national, or other standard method? | X | |
| Justification of the method/protocol if a non-standard method was used | ||
| *GLP (good laboratory practice) | X | |
| Test design/conditions | ||
| Study type (photodegradation, hydrolysis, biodegradation, other –specify, do not assess): Biodegradation | ||
| Test type (aerobic or anaerobic – specify, do not assess): Aerobic | ||
| Test medium (air, water, soil, sediment – specify, do not assess): activated sludge | ||
| Is information on stability of the substance in the media of concern reported? | X | |
| Controls (positive or negative): Negative and Positive (Reference) | X | |
| Number of replicates (including controls) | X | |
| Temperature | X | |
| Duration of the experiment | X | |
| For photodegradation only | ||
| Light source (specify): | ||
| Light spectrum and relative intensity based on sunlight intensity: | ||
| For hydrolysis only | ||
| Measured concentrations reported? | ||
| Basic water properties (pH, hardness, etc.) | ||
| For biodegradation only | ||
| Ready or inherent biodegradation (specify): Ready | X | |
| Inoculum (concentration and source): | X | |
| Results | ||
| Endpoints: Average oxygen uptake in controls, reference and treatments used to calculate biochemical oxygen demand (BOD) and percent degradation at each sampling interval. No degradation of the test substance was observed over the 28–day test period. | ||
| Information on breakdown products (do not assess this item):No<</td> | ||
| Overall score: 11/11 = 100 % | ||
| EC reliability code: 1 | ||
| Reliability category (high, satisfactory, low): High | ||
| Comments: | ||
Robust Study Summary - Persistence
| Item | Yes | No |
|---|---|---|
| Reference:ACCBFRIP. 2003b. Evaluation of aerobic and anaerobic transformation of hexabromocyclododecane in aquatic sediment systems. Environmental Chemistry Research Laboratory Project Study ID 021081. Midland (MI): The Dow Chemical Company March 5, 2003. | ||
| Test Substance(CAS RN and name): 3194-55-6, Cyclododecane, 1,2,5,6,9,10-hexabromo- (hexabromocyclododecane) | ||
| Chemical composition of the substance (including purity, by-products) | X | |
| Method | ||
| References | X | |
| OECD, EU, national, or other standard method? | X | |
| Justification of the method/protocol if a non-standard method was used | ||
| *GLP (good laboratory practice) | X | |
| Test design/conditions | ||
| Study type (photodegradation, hydrolysis, biodegradation, other –specify, do not assess): Biodegradation | ||
| Test type (aerobic or anaerobic – specify, do not assess): Aerobic and anaerobic | ||
| Test medium (air, water, soil, sediment – specify, do not assess): Sediment | ||
| Is information on stability of the substance in the media of concern reported? | X | |
| Controls (positive or negative): Negative | X | |
| Number of replicates (including controls) | X | |
| Temperature | X | |
| Duration of the experiment | X | |
| For photodegradation only | ||
| Light source (specify): | ||
| Light spectrum and relative intensity based on sunlight intensity: | ||
| For hydrolysis only | ||
| Measured concentrations reported? | ||
| Basic water properties (pH, hardness, etc.) | ||
| For biodegradation only | ||
| Ready or inherent biodegradation (specify): Ready | X | |
| Inoculum (concentration and source): | X | |
| Results | ||
| Endpoints: Concentration of target substance at selected time intervals throughout exposure period used to calculate biotransformation half-lives. Biotransformation half-lives for HBCD determined as 11 and 32 days in the aerobic system and 1.1 and 1.5 days in the anaerobic system. | ||
| Information on breakdown products (do not assess this item):Yes - not detected | ||
| Overall score: 11/11 = 100 % | ||
| EC reliability code: 1 | ||
| Reliability category (high, satisfactory, low): High | ||
| Comments: | ||
Robust Study Summary - Persistence
| Item | Yes | No |
|---|---|---|
| Reference:ACCBFRIP. 2003c. Evaluation of aerobic and anaerobic transformation of hexabromocyclododecane in soil. Environmental Chemistry Research Laboratory Project Study ID 021082. Midland (MI): The Dow Chemical Company March 5, 2003 | ||
| Test Substance(CAS RN and name): 3194-55-6, Cyclododecane, 1,2,5,6,9,10-hexabromo- (hexabromocyclododecane) | ||
| Chemical composition of the substance (including purity, by-products) | X | |
| Method | ||
| References | X | |
| OECD, EU, national, or other standard method? | X | |
| Justification of the method/protocol if a non-standard method was used | ||
| *GLP (good laboratory practice) | X | |
| Test design/conditions | ||
| Study type (photodegradation, hydrolysis, biodegradation, other –specify, do not assess): Biodegradation | ||
| Test type (aerobic or anaerobic – specify, do not assess): Aerobic and anaerobic | ||
| Test medium (air, water, soil, sediment – specify, do not assess): Soil | ||
| Is information on stability of the substance in the media of concern reported? | X | |
| Controls (positive or negative): Negative | X | |
| Number of replicates (including controls) | X | |
| Temperature | X | |
| Duration of the experiment | X | |
| For photodegradation only | ||
| Light source (specify): | ||
| Light spectrum and relative intensity based on sunlight intensity: | ||
| For hydrolysis only | ||
| Measured concentrations reported? | ||
| Basic water properties (pH, hardness, etc.) | ||
| For biodegradation only | ||
| Ready or inherent biodegradation (specify): Ready | X | |
| Inoculum (concentration and source): | X | |
| Results | ||
| Endpoints: Concentration of target substance at selected time intervals throughout exposure period used to calculate biotransformation half-lives. Biotransformation half-lives for HBCD determined to be 63 and 6.9 days in the aerobic and anaerobic soils, respectively. | ||
| Information on breakdown products (do not assess this item): Yes - not detected | ||
| Overall score: 11/11 = 100 % | ||
| EC reliability code: 1 | ||
| Reliability category (high, satisfactory, low): High | ||
| Comments: | ||
Robust Study Summary - Persistence
| Item | Yes | No |
|---|---|---|
| Reference:EBFRIP. 2004. Investigation of the biodegradation of [14C]hexabromocyclododecane in sludge, sediment, and soil. Toxicology and Environmental Research and Consulting Laboratory Project Study ID 031178. Midland (MI): The Dow Chemical Company November 30, 2004. | ||
| Test Substance(CAS RN and name): 3194-55-6, Cyclododecane, 1,2,5,6,9,10-hexabromo- (hexabromocyclododecane) | ||
| Chemical composition of the substance (including purity, by-products) | X | |
| Method | ||
| References | X | |
| OECD, EU, national, or other standard method? | X | |
| Justification of the method/protocol if not a standard method was used | ||
| *GLP (good laboratory practice) | X | |
| Test design / conditions | ||
| Study type (photodegradation, hydrolysis, biodegradation, other –specify, do not assess): Biodegradation | ||
| Test type (aerobic or anaerobic – specify, do not assess): Aerobic and anaerobic | ||
| Test medium (air, water, soil, sediment – specify, do not assess: Soil, sediment and sludge | ||
| Is information on stability of the substance in the media of concern reported? | X | |
| Controls (positive or negative): Negative | X | |
| Number of replicates (including controls) | X | |
| Temperature | X | |
| Duration of the experiment | X | |
| For photodegradation only | ||
| Light source (specify): | ||
| Light spectrum and relative intensity based on sunlight intensity: | ||
| For hydrolysis only | ||
| Measured concentrations reported? | ||
| Basic water properties (pH, hardness, etc.) | ||
| For biodegradation only | ||
| Ready or inherent biodegradation (specify): Ready | X | |
| Inoculum (concentration and source): | X | |
| Results | ||
| Endpoints: Numerical endpoints not determined as objective of study was to investigate pathways and major products formed during degradation. | ||
| Information on breakdown products (do not assess this item):Yes | ||
| Overall score: 11/11 = 100 % | ||
| EC reliability code: 1 | ||
| Reliability category (high, satisfactory, low): High | ||
| Comments: | ||
Robust Study Summary - Persistence
| Item | Yes | No |
|---|---|---|
| Reference:Gerecke AC et al. 2006. Anaerobic degradation of brominated flame retardants in sewage sludge. Chemosphere 64:311–317. | ||
| Test Substance(CAS RN and name): 3194-55-6, Cyclododecane, 1,2,5,6,9,10-hexabromo- (hexabromocyclododecane) | ||
| Chemical composition of the substance (including purity, by-products): purity, not composition | X | |
| Method | ||
| References | X | |
| OECD, EU, national, or other standard method? | X | |
| Justification of the method/protocol if a non-standard method was used | X | |
| *GLP (good laboratory practice) | not known | |
| Test design/conditions | ||
| Study type (photodegradation, hydrolysis, biodegradation, other –specify, do not assess): Biodegradation | ||
| Test type (aerobic or anaerobic – specify, do not assess): Anaerobic | ||
| Test medium (air, water, soil, sediment – specify, do not assess): Sewage sludge | ||
| Is information on stability of the substance in the media of concern reported? | X | |
| Controls (positive or negative): Negative | X | |
| Number of replicates (including controls): Not specifically but range (see Comments) | X | |
| Temperature | X | |
| Duration of the experiment: Not specifically but upper limit (see Comments) | X | |
| For photodegradation only | ||
| Light source (specify): | ||
| Light spectrum and relative intensity based on sunlight intensity: | ||
| For hydrolysis only | ||
| Measured concentrations reported? | ||
| Basic water properties (pH, hardness, etc.) | ||
| For biodegradation only | ||
| Ready or inherent biodegradation (specify): Ready | X | |
| Inoculum (concentration and source): | X | |
| Results | ||
| Endpoints: Degradation rate constants and half-lives for technical mixture and individual isomers. Only values for technical mixture reported. Rate constant for technical HBCD was 1.1 ± 0.3 d-1, corresponding to a half-life of 0.66 day. | ||
| Information on breakdown products (do not assess this item):No | ||
| Overall score: 8/11 = 73 % | ||
| EC reliability code: 2 | ||
| Reliability category (high, satisfactory, low): Satisfactory | ||
| Comments: Study is reported in a journal article and therefore not all details are included. Several brominated flame retardants were tested at the same time and the article reports overall methodology and results. While the method used is not standard, it appears to be scientifically sound and the study well conducted. Some important information (such as the number of replicates and exposure duration for the HBCD testing) is not provided. | ||
Robust Study Summary - Bioaccumulation
| Item | Yes | No |
|---|---|---|
| Reference: Veith et al. 1979. Measuring and estimating the bioconcentration factor of chemicals in fish. J Fish Res Board Can 36:1040–1048. | ||
| Test Substance(CAS RN and name): 3194-55-6 (Hexabromocyclododecane) | ||
| *Chemical composition of the substance (including purity, by-products) | X | |
| Persistence/stability of test substance in test system | X | |
| Method | ||
| References | X | |
| *OECD, EU, national, or other standard method? | X | |
| Justification of the method/protocol if a non-standard method was used? | n/a | |
| *GLP (good laboratory practice) | n/a | |
| Test organisms(specify common and Latin names): fathead minnow (Pimephales promelas) | ||
| Latin or both Latin and common names reported? | X | |
| Life cycle age / stage of test organism | X | |
| Sex | n/a | |
| Length and weight of test organisms | X | |
| Number of test organisms per replicate | X | |
| Food type / feeding periods (acclimation/during test) | X | |
| Test design/conditions | ||
| Test type (field, laboratory): laboratory | X | |
| Number of replicates (including controls) and concentrations | X | |
| *Measured concentrations reported? Mean measured exposure concentration reported; description of test methodology specifies that concentration was measured each weekday | X | |
| *Was the chemical concentration in the water below the chemical’s water solubility? Mean measured concentration 6 µg/L; water solubility 3.4-8.6 µg/L | X | |
| *Experiment duration equal to or longer than the time required for the chemical concentration in the organism and water to reach steady state? Exposure time 32 days; steady state BCF calculated from 32-day exposure. | X | |
| Exposure media conditions (temperature, pH, TOC, DOC, DO, other) reported? Temp., DO (saturation), hardness, alkalinity, pH of test water reported | X | |
| Photoperiod and light intensity: specifies that USEPA Methods (1975) used | X | |
| Stock and test solution preparation | X | |
| Information on emulsifiers used for poorly soluble / unstable substances | X | |
| Statistical methods used | X | |
| Was pH within 6–9 range? (do not assess this item) | X | |
| Was temperature within 5–28°C range? (do not assess this item) | X | |
| Results | ||
| Endpoints and values (BAF, BCF, or log Kow; do not assess this item): BCF = 18 100 | ||
| BAF or BCF either as: 1) the ratio of chemical concentration in the organism and in water, or 2) the ratio of the chemical uptake and elimination rate constants (1 or 2 – specify;do not assess this item): 1 | ||
| Whether BAF/BCF was derived from a tissue sample or whole organism (do not assess this item)? | X | |
| Indication of whether average BAF/BCF was used (specify;do not assess this item) | X | |
| Indication of whether max BAF/BCF was used (specify;do not assess this item) | X | |
| *BAF/BCF reported on a lipid-normalized basis, or was the lipid % reported? | X | |
| Score: major items - 5/6; overall score: 17/20 = 85% | ||
| Reliability (Klimisch) code: 1 > | ||
| Reliability category (high, satisfactory, low):High | ||
| Comments: | ||
Robust Study Summary - Bioaccumulation
| Item | Yes | No |
|---|---|---|
| Reference: CMABFRIP. 2000. Hexabromocyclododecane (HBCD): A flow-through bioconcentration test with the rainbow trout (Oncorhychus mykiss). Easton (MD): Wildlife International Ltd. Project No. 439A-11. | ||
| Test Substance(CAS RN and name): 3194-55-6 (Hexabromocyclododecane) | ||
| *Chemical composition of the substance (including purity, by-products) | X | |
| Persistence/stability of test substance in test system | X | |
| Method | ||
| References | X | |
| *OECD, EU, national, or other standard method? | X | |
| Justification of the method/protocol if a non-standard method was used? | n/a | |
| *GLP (good laboratory practice) | X | |
| Test organisms(specify common and Latin names): rainbow trout (Oncorhynchus mykiss) | ||
| Latin or both Latin and common names reported? | X | |
| Life cycle age / stage of test organism: same source and year class | X | |
| Sex | n/a | |
| Length and weight of test organisms | X | |
| Number of test organisms per replicate | X | |
| Food type / feeding periods (acclimation/during test) | X | |
| Test design/conditions | ||
| Test type (field, laboratory): laboratory | X | |
| Number of replicates (including controls) and concentrations | X | |
| *Measured concentrations reported? | X | |
| *Was the chemical concentration in the water below the chemical’s water solubility? | X | |
| *Experiment duration equal to or longer than the time required for the chemical concentration in the organism and water to reach steady state? Steady state achieved at highest test concentration, but not at lowest | X | |
| Exposure media conditions (temperature, pH, TOC, DOC, DO, other) reported? Temp., DO, pH, hardness, alkalinity, conductivity, TOC reported | X | |
| Photoperiod and light intensity: | X | |
| Stock and test solution preparation | X | |
| Information on emulsifiers used for poorly soluble / unstable substances | X | |
| Statistical methods used | X | |
| Was pH within 6–9 range? (do not assess this item) | X | |
| Was temperature within 5–28°C range? (do not assess this item) | X | |
| Results | ||
| Endpoints and values (BAF, BCF, or log Kow; do not assess this item): Day 35 BCF for 0.34 µg/L test concentration = 6531 (edible), 20 726 (nonedible), 13 085 (whole fish) NB. Steady-state not achieved at this concentration. Steady-state day 35 BCF at 3.4 µg/L test concentration = 4650 (edible), 12,866 (nonedible), 8974 (whole fish). | ||
| BAF or BCF either as: 1) the ratio of chemical concentration in the organism and in water, or 2) the ratio of the chemical uptake and elimination rate constants (1 or 2 – specify;do not assess this item): 1 | ||
| Whether BAF/BCF was derived from a tissue sample or whole organism (do not assess this item)? | X | |
| Indication of whether average BAF/BCF was used (specify;do not assess this item) | X | |
| Indication of whether max BAF/BCF was used (specify;do not assess this item) | X | |
| *BAF/BCF reported on a lipid-normalized basis, or was the lipid % reported? | X | |
| Score: major items - 6/7; overall score: 20/21 = 95% | ||
| Reliability (Klimisch) code: 1 | ||
| Reliability category (high, satisfactory, low):High | ||
| Comments: | ||
Robust Study Summary - Inherent Toxicity
| Item | Yes | No |
|---|---|---|
| Reference: CMABFRIP. 1988. Hexabromocyclododecane (HBCD): A flow-through life-cycle toxicity test with the cladoceran (Daphnia magna). Easton (MD): Wildlife International Ltd. Project No.439A-108. | ||
| Test Substance(CAS RN and name): 3194-55-6 (Hexabromocyclododecane) | ||
| *Chemical composition of the substance (including purity, by-products) | X | |
| Persistence/stability of test substance in test system | X | |
| Method | ||
| References | X | |
| *OECD, EU, national, or other standard method? | X | |
| Justification of the method/protocol if a non-standard method was used | ||
| *GLP (good laboratory practice) | X | |
| Test organisms(specify common and Latin names): Water flea (Daphnia magna) | ||
| Latin or both Latin and common names reported? | X | |
| Life cycle age / stage of test organism | X | |
| Sex | n/a | |
| Length and weight of test organisms | X | |
| Number of test organisms per replicate | X | |
| Food type / feeding periods (acclimation/during test) | X | |
| Test design/conditions | ||
| Test type – acute or chronic (specify, butdo not assess this item): chronic | ||
| Experiment type (laboratory or field) specified? | X | |
| System type (static, semi-static, flow through)? | X | |
| Negative or positive controls (specify)? Negative and solvent controls | X | |
| Number of replicates (including controls) and concentrations | X | |
| Exposure pathways (food, water, both) | X | |
| Exposure duration | X | |
| *Measured concentrations reported? | X | |
| Exposure media conditions (temperature, pH, electrical conductivity, hardness, TOC, DOC, DO, major cations and anions; other) | X | |
| Was pH within 6–9 range? (do not assess this item) | X | |
| Was temperature within 5–28°C range? (do not assess this item) | X | |
| Photoperiod and light intensity | X | |
| Stock and test solution preparation | X | |
| Use of emulgators/solubilizers (especially for poorly soluble / unstable substances) | X | |
| Analytical monitoring intervals | X | |
| Statistical methods used | X | |
| Results | ||
| Toxicity values (LC50, EC50, or IC50 - specify,do not assess this item): 21-day LOEC (survival) > 11 µg/L, 21-day LOEC (reproduction) = 11 µg/L, 21-day LOEC (growth) = 5.6 µg/L, 21-day NOEC (overall study) = 3.1 µg/L | ||
| Other endpoints reported – e.g., BCF/BAF (specify,do not assess this item): 21-day MATC = 4.2 µg/L | ||
| *Was toxicity value below the chemical’s water solubility? | X | |
| Other adverse effects (carcinogenicity, mutagenicity, etc.Do not assess this item) | X | |
| Score: major items – 5/5; overall score – 24/25 (96%) | ||
| EC Reliability code: 1 | ||
| Reliability category (high, satisfactory, low): high | ||
| Comments: All major items reported “yes”; overall score 96%. Lowest toxicity value (5.6 µg/L) was slightly above the water solubility value of 3.4 µg/L (25°C) used by the study authors. However, a measured water solubility been reported by EBFRIP (2004a) in the range of 2.08 to 48.8 µg/L (20°C) for the individual diastereomers. Temperature 19.0–20.5°C. DO 7.2–8.8 mg/L. pH 8.1–8.4. Hardness 128–132 mg/L as CaCO3. Alkalinity 176–178 mg/L as CaCO3. Conductivity 310–320 µmhos/cm. Dimethylformamide solvent used. Good control performance, test concentrations well maintained throughout exposure period. | ||
Robust Study Summary - Inherent Toxicity
| Item | Yes | No |
|---|---|---|
| Reference: EBFRIP. 2004b. Hexabromocyclododecane (HBCD): A 72-hour toxicity test with the marine diatom (Skeletonema costatum). Easton (MD): Wildlife International Ltd. Project No. 439A-125. | ||
| Test Substance(CAS RN and name): 3194-55-6 (Hexabromocyclododecane) | ||
| *Chemical composition of the substance (including purity, by-products) | X | |
| Persistence/stability of test substance in test system | X | |
| Method | ||
| References | X | |
| *OECD, EU, national, or other standard method? | X | |
| Justification of the method/protocol if a non-standard method was used | ||
| *GLP (good laboratory practice) | X | |
| Test organisms(specify common and Latin names): marine alga (Skeletonema costatum) | ||
| Latin or both Latin and common names reported? | X | |
| Life cycle age / stage of test organism | n/a | |
| Sex | n/a | |
| Length and weight of test organisms | n/a | |
| Number of test organisms per replicate | n/a | |
| Food type / feeding periods (acclimation/during test) | X | |
| Test design/conditions | ||
| Test type – acute or chronic (specify, butdo not assess this item): acute | ||
| Experiment type (laboratory or field) specified? | X | |
| System type (static, semi-static, flow through)? | X | |
| Negative or positive controls (specify)? Negative and media controls | X | |
| Number of replicates (including controls) and concentrations | X | |
| Exposure pathways (food, water, both) | X | |
| Exposure duration | X | |
| *Measured concentrations reported? | X | |
| Exposure media conditions (temperature, pH, electrical conductivity, hardness, TOC, DOC, DO, major cations and anions; other) | X | |
| Was pH within 6–9 range? (do not assess this item) | X | |
| Was temperature within 5–28°C range? (do not assess this item) | X | |
| Photoperiod and light intensity | X | |
| Stock and test solution preparation | X | |
| Use of emulgators/solubilizers (especially for poorly soluble / unstable substances) | X | |
| Analytical monitoring intervals | X | |
| Statistical methods used | X | |
| Results | ||
| Toxicity values (LC50, EC50, or IC50 - specify,do not assess this item): 72-hour EC50 (cell density, area under growth curve, growth rate) > 41.0 µg/L | ||
| Other endpoints reported - BCF/BAF, LOEC/NOEC (specify,do not assess this item): 72-hour NOEC (cell density, area under growth curve, growth rate) < 41.0 µg/L | ||
| *Was toxicity value below the chemical’s water solubility? | X | |
| Other adverse effects (carcinogenicity, mutagenicity, etc.Do not assess this item) | X | |
| Score: major items – 5/5; overall score – 22/22 (100%) | ||
| EC reliability code: 1 | ||
| Reliability category (high, satisfactory, low): high | ||
| Comments: All major items reported “yes”; overall score 100%. Selected test concentration (41.0 µg/L) is well above reported water solubility of 3.4 µg/L (25°C) for sum HBCD; however, a recent study by EBFRIP (2004a) measured solubility values of 2.08 to 48.8 µg/L at 20°C for the individual diastereomers. Therefore, although a toxic endpoint was not determined in the present study, consider the reported results to be meaningful within the context of a rangefinder test. Temperature 18.0–22.0°C. pH 7.9–8.4. Light intensity 4130–4660 lux. Control growth over the 3-day test period was 10–11x, and less than the OECD recommended 16x for test validity. However, consider that the response between controls and test solution was sufficiently delineated to indicate that inhibition was occurring in the test substance flasks. | ||
Robust Study Summary - Inherent Toxicity
| Item | Yes | No |
|---|---|---|
| Reference: Oetken et al. 2001. Validation of the preliminary EU-concept of assessing the impact of chemicals to organisms in sediment by using selected substances. UBA-FB 299 67 411. Dresden (DE): Institute of Hydrobiology, Dresden University of Technology | ||
| Test Substance(CAS RN and name): 3194-55-6 (Hexabromocyclododecane) | ||
| *Chemical composition of the substance (including purity, by-products) | X | |
| Persistence/stability of test substance in test system | X | |
| Method | ||
| References | X | |
| *OECD, EU, national, or other standard method? | X | |
| Justification of the method/protocol if a non -standard method was used | ||
| *GLP (good laboratory practice) | Not reported | |
| Test organisms(specify common and Latin names): Oligochaete (Lumbriculus variegatus) | ||
| Latin or both Latin and common names reported? | X | |
| Life cycle age / stage of test organism | X | |
| Sex | n/a | |
| Length and weight of test organisms | X | |
| Number of test organisms per replicate | X | |
| Food type / feeding periods (acclimation/during test) | X | |
| Test design/conditions | ||
| Test type – acute or chronic (specify, butdo not assess this item): chronic | ||
| Experiment type (laboratory or field) specified? | X | |
| System type (static, semi-static, flow through)? | X | |
| Negative or positive controls (specify)? Negative and solvent controls | X | |
| Number of replicates (including controls) and concentrations | X | |
| Exposure pathways (food, water, both) | X | |
| Exposure duration | X | |
| *Measured concentrations reported? | X | |
| Exposure media conditions (temperature, pH, electrical conductivity, hardness, TOC, DOC, DO, major cations and anions; other) | X | |
| Was pH within 6–9 range? (do not assess this item) | X | |
| Was temperature within 5–28°C range? (do not assess this item) | X | |
| Photoperiod and light intensity | n/a | |
| Stock and test solution preparation | X | |
| Use of emulgators/solubilizers (especially for poorly soluble / unstable substances) | X | |
| Analytical monitoring intervals | X | |
| Statistical methods used | X | |
| Results | ||
| Toxicity values (LC50, EC50, or IC50 - specify,do not assess this item): 28-day NOEC (no. of worms) = 3.25 mg/kg sediment dry weight; 28-day LOEC (no. of worms) = 29.25 mg/kg sediment dry weight; 28-day NOEC (large vs. small worms, mean biomass) = 29.25 mg/kg sediment dry weight; 28-day LOEC (large vs. small worms, mean biomass) = 311.35 mg/kg sediment dry weight. | ||
| Other endpoints reported - BCF/BAF (specify,do not assess this item): | ||
| *Was toxicity value below the chemical’s water solubility? | n/a | |
| Other adverse effects (carcinogenicity, mutagenicity, etc.Do not assess this item) deformation (none) | X | |
| Score: major items – 2/4; overall score – 20/22 (91%) | ||
| EC Reliability code: 2 | ||
| Reliability category (high, satisfactory, low): satisfactory | ||
| Comments: An OECD guideline (218) was used with modifications and while GLP has not been specified in the report, the description of the methodology is consistent with GLP. Consider that the study has met basic scientific principles, and that all necessary data and documentation have been presented. Temperature 20°C. DO 7.52 ± 0.81 mg/L. pH 8.7 ± 0.15. Conductivity 1026 ± 199 µs/cm. | ||
Robust Study Summary - Inherent Toxicity
| Item | Yes | No |
|---|---|---|
| Reference: ACCBFRIP. 2003a. Effect of hexabromocyclododecane on the survival and reproduction of the earthworm, Eisenia fetida. Columbia (MI): ABC Laboratories Inc. Study No. 47222. | ||
| Test Substance(CAS RN and name): 3194-55-6 (Hexabromocyclododecane) | ||
| *Chemical composition of the substance (including purity, by-products) | X | |
| Persistence/stability of test substance in test system | X | |
| Method | ||
| References | X | |
| *OECD, EU, national, or other standard method? | X | |
| Justification of the method/protocol if a non-standard method was used | ||
| *GLP (good laboratory practice) | X | |
| Test organisms(specify common and Latin names): Earthworm (Eisenia fetida) | ||
| Latin or both Latin and common names reported? | X | |
| Life cycle age / stage of test organism | X | |
| Sex | n/a | |
| Length and weight of test organisms | X | |
| Number of test organisms per replicate | X | |
| Food type / feeding periods (acclimation/during test) | X | |
| Test design/conditions | ||
| Test type – acute or chronic (specify, butdo not assess this item): chronic | ||
| Experiment type (laboratory or field) specified? | X | |
| System type (static, semi-static, flow through)? | X | |
| Negative or positive controls (specify)? Negative control | X | |
| Number of replicates (including controls) and concentrations | X | |
| Exposure pathways (food, water, both) | X | |
| Exposure duration | X | |
| *Measured concentrations reported? | X | |
| Exposure media conditions (temperature, pH, electrical conductivity, hardness, TOC, DOC, DO, major cations and anions; other) | X | |
| Was pH within 6–9 range? (do not assess this item) | X | |
| Was temperature within 5–28°C range? (do not assess this item) | X | |
| Photoperiod and light intensity | X | |
| Stock and test solution preparation | X | |
| Use of emulgators/solubilizers (especially for poorly soluble / unstable substances) | n/a | |
| Analytical monitoring intervals | X | |
| Statistical methods used | X | |
| Results | ||
| Toxicity values (LC50, EC50, or IC50 - specify,do not assess this item): 28-day EC10 and EC50 (survival) > 4190 mg/kg soil dry weight; 56-day EC10 (reproduction) = 21.6 mg/kg with 95% confidence limits of 0.000468 to 110 mg/kg; 56-day EC50(reproduction) = 771 mg/kg with 95% confidence limits of 225 to 4900 mg/kg | ||
| Other endpoints reported - BCF/BAF, LOEC/NOEC (specify,do not assess this item): 28-day NOEC (survival) = 4190 mg/kg soil dry weight; 56-day NOEC (reproduction) = 128 mg/kg soil dry weight; 56-day LOEC (reproduction) = 235 mg/kg soil dry weight; BAFs ranging from 0.026 to 0.069. | ||
| *Was toxicity value below the chemical’s water solubility? | n/a | |
| Other adverse effects (carcinogenicity, mutagenicity, etc.Do not assess this item) | X | |
| Score: major items – 4/4; overall score – 22/22 (100%) | ||
| EC reliability code: 1 | ||
| Reliability category (high, satisfactory, low): high | ||
| Comments: Good control performance. Temperature 19.4–22.7°C. pH 5.50–6.67. Soil moisture 18.9–42.3%. Light intensity 573.4–595.5 lux. Should note, however, that preparation of test soils differed from that suggested by ASTM and bioaccumulation factors were reported based on concentration in tissue (ppm) relative to average 28-day concentration in soil. | ||