Final Assessment
Appendicies
Appendix A. Triclosan Products Registered under the Pest Control Products Act
Exposure scenario | Dose (mg/kg bw per day) | Study | Toxicological effects | Database UF | PCPA factor | CAF or target MOE |
---|---|---|---|---|---|---|
ADI / aggregate All populations |
NOAEL = 25 ADI = 0.08 |
90-day toxicity study in mice | Increased liver weights and liver pathology, decrease in hematology parameters (red blood cells, hemoglobin and hematocrit) and cholesterol at 75 mg/kg bw per day | 3 (lack of DNT study) | 1 | 300a |
Short-term incidental oral (direct exposure of children) | NOAEL = 25 | As per ADI (above) | As above | 3 (lack of DNT study) | 1 | 300a |
Dermal (all durations) | NOAEL = 40 | 90-day dermal toxicity study in rats | Based on increased incidence of occult blood in the urine, minor decrease in hematology parameters (red blood cells, hemoglobin, hematocrit), decrease in triglyceride (males) and cholesterol levels (males and females) and a slight focal degeneration of cortical tubules in males at 80 mg/kg bw per day | 3 (lack of DNT study) | 1 | 300a |
Acute, short-term, intermediate-term and long-term inhalation |
NOAEL = 3.21 | 21-day inhalation toxicity study in rats | Based on decreased thrombocytes and total serum proteins, increased alkaline phosphatase in male rats at 3.21 mg/kg bw per day | 3 (lack of DNT study) | 1 | 300a |
Table Notes
Abbreviations used: ADI, acceptable daily intake; CAF, composite assessment factor; DNT, developmental neurotoxicity; NOAEL, no-observed-adverse-effect level; PCPA, Pest Control Products Act; target MOE, target margin of exposure for occupational and residential assessments; UF, uncertainty factor.
a CAF/target MOE of 300 based on the application of a 10-fold uncertainty factor to account for interspecies extrapolation and a 10-fold uncertainty factor for intraspecies variation, as well as a 3-fold database deficiency factor (for lack of a DNT study). The PCPA factor was reduced to 1-fold, since uncertainties with respect to the completeness of the data were accounted for through application of the database deficiency factor, and there was a low level of concern for prenatal and postnatal toxicity given the endpoints and uncertainty factors selected for risk assessment.
Appendix B. Unadjusted, Specific Gravity and Creatinine Adjusted Urinary Triclosan Concentrations per Unit Body Weight (ug/L/kg)
In order to estimate daily intakes from the spot urinary triclosan concentrations, the body weight of each individual was incorporated to give urinary triclosan concentrations in units of µg/L/kg. This was done by dividing the concentration by each individual’s body weight.
Gender | Age | Geometric Mean (95% CI) |
95th Percentile (95% CI) |
---|---|---|---|
Males and Females | 3-79 | 0.22 (0.17-0.28) | 11 (7.3-14) |
Males and Females | 3-5 | 0.45 (0.36-0.55) | 6.4 (4.2-8.7) |
Males and Females | 6-11 | 0.24 (0.18-0.31) | 8.5E (4.1-13) |
Males and Females | 12-19 | 0.30 (0.22-0.42) | 12E (7.2-17) |
Males and Females | 20-59 | 0.24E (0.16-0.36) | 12 (7.4-16) |
Males and Females | 60-79 | -- | 8.0 (5.7-10) |
Males | 3-79 | 0.24E (0.16-0.35) | 11E (5.2-17) |
Males | 6 -11 | 0.23E (0.15-0.36) | F |
Males | 12-19 | 0.30E (0.20-0.45) | F |
Males | 20-59 | 0.25E (0.14-0.45) | 12E (4.6-20) |
Males | 60-79 | 0.15E (0.083-0.27) | X |
Females | 3-79 | 0.20 (0.16-0.27) | 10 (7.0-14) |
Females | 6-11 | 0.24E (0.15-0.36) | F |
Females | 12-19 | 0.31E (0.20-0.49) | 13E (8.0-18) |
Females | 20-59 | 0.23E (0.15-0.35) | 11E (6.4-16) |
Females | 60-79 | -- | X |
Females | 13-49 | 0.28E (0.18-0.42) | 12 (8.2-16) |
Table Notes
(--) If greater than 40% of samples were below the LOD, the percentile distribution is reported but means were not calculated.
E = Use date with caution.
F = Data is too unreliable to be published.
X = Supressed to meet the confidentiality requirements of the Statistics Act
Gender | Age | Geometric Mean (95% CI) |
95th Percentile (95% CI) |
---|---|---|---|
Males and Females | 3-79 | 0.33 (0.26-0.43) | 14 (10-17) |
Males and Females | 3-5 | 0.57 (0.47-0.69) | 7.2 (4.9-9.5) |
Males and Females | 6-11 | 0.29 (0.21-0.39) | 9.6E (2.8-16) |
Males and Females | 12-19 | 0.38 (0.29-0.52) | 12E (5.7-19) |
Males and Females | 20-59 | 0.37E (0.24-0.55) | 15 (10-19) |
Males and Females | 60-79 | -- | 10E (4.4-16) |
Males | 3-79 | 0.33E (0.22-0.48) | 14 (9.8-18) |
Males | 6-11 | 0.27E (0.17-0.42) | F |
Males | 12-19 | 0.35E (0.23-0.54) | F |
Males | 20-59 | 0.35E (0.19-0.65) | 16 (11-21) |
Males | 60-79 | 0.22E (0.14-0.36) | X |
Females | 3-79 | 0.34 (0.26-0.44) | 12E (7.2-17) |
Females | 6-11 | 0.31E (0.20-0.48) | F |
Females | 12-19 | 0.42E (0.27-0.64) | 14E (7.7-21) |
Females | 20-59 | 0.38E (0.25-0.58) | 13E (7.8-19) |
Females | 60-79 | -- | X |
Females | 13-49 | 0.43E (0.28-0.65) | 16E (9.5-22) |
Table Notes
(--) If greater than 40% of samples were below the LOD, the percentile distribution is reported but means were not calculated.
E = Use data with caution.
F = Data is too unreliable to be published.
X = Supressed to meet the confidentiality requirements of the Statistics Act
Gender | Age | Geometric Mean (95% CI) |
95th Percentile (95% CI) |
---|---|---|---|
Males and Females | 3-79 | 0.22 (0.17-0.28) | 8.8E (5.5-12) |
Males and Females | 3-5 | 0.78 (0.65-0.92) | 10 (8.3-12) |
Males and Females | 6-11 | 0.27 (0.19-0.37) | 8.0E (3.1-13) |
Males and Females | 12-19 | 0.23 (0.17-0.32) | 7.9E (4.4-11) |
Males and Females | 20-59 | 0.23E (0.15-0.34) | 10E (5.3-15) |
Males and Females | 60-79 | -- | 6.9E (3.2-10) |
Males | 3-79 | 0.21 (0.14-0.30) | 9.8E (3.9-16) |
Males | 6-11 | 0.27E (0.16-0.44) | 9.7E (2.9-17) |
Males | 12-19 | 0.21E (0.14-0.33) | F |
Males | 20-59 | 0.21E (0.12-0.37) | 12E (3.5-19) |
Males | 60-79 | 0.14E (0.088-0.22) | X |
Females | 3-79 | 0.24 (0.18-0.31) | 8.7E (5.5-12) |
Females | 6-11 | 0.27E (0.18-0.42) | F |
Females | 12-19 | 0.26E (0.17-0.38) | 7.9E (2.6-13) |
Females | 20-59 | 0.25E (0.17-0.38) | 8.8E (4.7-13) |
Females | 60-79 | -- | X |
Females | 13-49 | 0.27E (0.18-0.40) | 9.9E (5.5-14) |
Table Notes
(--) If greater than 40% of samples were below the LOD, the percentile distribution is reported but means were not calculated.
E = Use data with caution
F = Data is too unreliable to be published.
X = Supressed to meet the confidentiality requirements of the Statistics Act
Study | Type | Age | Na | Geometric Mean (95% CI) |
95th Percentile (95% CI) |
---|---|---|---|---|---|
P4 | Unadjusted | less than 25-40+ | 1096 | 0.29 (0.24-0.35) | 11.70 (10.6-13.27) |
P4 | SG-Adjusted | less than 25-40+ | 1096 | 0.32 (0.27-0.38) | 11.42 (1.00-13.09) |
P4 | Unadjusted | 0-3 months old | 95 | 0.72 (0.42-1.23) | 12.62 (5.83-27.87) |
P4 | SG-Adjusted | 0-3 months old | 95 | 0.64 (0.38-1.10) | 12.17 (5.97-18.53) |
MIREC | Unadjusted | less than 25- greater than or equal to 35 | 1755 | 0.19 (0.17-0.21) | 10.79 |
MIREC | SG-Adjusted | less than 25- greater than or equal to 35 | 1753 | 0.21 (0.19-0.23) | 8.50 |
Table Notes
a For P4 Study, "N" refers to number of urine samples. For MIREC Study, "N" refers to number of individual participant.
Appendix C: Range of Typical Daily Urine Volumes
Gender | Age (years) | Daily Mean Urine Volumes (L/day) |
Reference |
---|---|---|---|
Males and Females | 0-3 months | 0.015-0.580 | Aggarwal et al [date not specified]; Ingelfinger 1991; Lentner 1981; Prentice 1987; Walker 2011; Wu 2006; Water UK 2006 |
Males and Females | 1-3 years | 0.4-0.6 | ICRP 2003 and Wu 2006 |
Males and Females | 3-5 | 0.449 - 0.7 | ICRP 2003; Lakind and Naiman 2008; Lentner 1981; Wu 2006 |
Males and Females | 6-11 | 0.274-1.14 | ICRP 2003; Lakind and Naiman 2008; Lentner 1981; Remer et al. 2006; Wu 2006 |
Males and Females | 12-19 | 0.441-1.4 | ICRP 2003; Lentner 1981; Wu 2006 |
Males and Females | 20-59 | 0.6-2.03 | Addis and Watanabe 1961; Davison and Nobel 1981; Francis 1960; ICRP 2003; Lakind and Naiman 2008; Lentner 1981; Parboosingh and Doig 1973; Perucca et al. 2007; Revúsová 1971; Wu 2006 |
Males | 20-59 | 0.8-1.8 | Addis and Watanabe 1961; ICRP 2003; Lentner 1981; Perucca et al. 2007; Revúsová 1971; Wu 2006 |
Females | 20-59 | 0.6-2.03 | Addis and Watanabe 1961; Davison and Nobel 1981; Francis 1960; ICRP 2003; Lakind and Naiman 2008; Lentner 1981; Parboosingh and Doig 1973; Perucca et al. 2007; Revúsová 1971; Wu 2006 |
Pregnant Females | NA | 0.8-2.7 | Davison and Nobel 1981; Francis 1960; Higby et al. 1994; Neithardt et al. 2002; Parboosingh and Doig 1973; Thorp et al. 1999; |
Males and Females | 60-79 | 0.25-2.4 | ICRP 2003; Lentner 1981; Wu 2006 |
Table Notes
Abbreviation: NA, not applicable.
Appendix D. Estimated Daily Doses
Gender | Age | Geometric Mean | 95th Percentile |
---|---|---|---|
Males and Females | 3-5 | 0.37-0.58 | 5.32-8.30 |
Males and Females | 6-11 | 0.12-0.51 | 4.31-17.94 |
Males and Females | 12-19 | 0.25-0.78 | 9.80-31.11 |
Males and Females | 20-59 | 0.27-0.90 | 13.33-45.11 |
Males and Females | 60-79 | -- | 3.70-35.56 |
Males | 6-11 | 0.12-0.49 | F |
Males | 12-19 | 0.25-0.78 | F |
Males | 20-59 | 0.37-0.83 | 17.78-40.00 |
Males | 60-79 | 0.07-0.67 | X |
Females | 6-11 | 0.12-0.51 | F |
Females | 12-19 | 0.25-0.80 | 10.62-33.70 |
Females | 20-59 | 0.26-0.86 | 12.22-41.35 |
Females | 60-79 | -- | X |
Females | 13-49 | 0.31-1.05 | 13.33-45.11 |
Pregnant Women (P4) | less than 25-40+ | 0.43-1.45 | 17.33-58.50 |
Pregnant Women (MIREC) | less than 25- greater than or equal to 35 | 0.28-0.93 | 15.98-53.92 |
Infants (P4) |
0-3 months old | 0.02-0.77 | 0.35-13.55 |
Table Notes
(--) If greater than 40% of samples were below the LOD, the percentile distribution is reported but means were not calculated.
F = Data is too unreliable to be published.
X = Supressed to meet the confidentiality requirements of the Statistics Act.
a Daily Dose = Unadjusted Urine Concentration (µg/L/kg) x Daily Urine Volume (L/day) / Urinary Excretion Fraction (FUE = 0.54).
Gender | Age | Geometric Mean | 95th Percentile |
---|---|---|---|
Males and Females | 3-5 | 0.47-0.74 | 5.99-9.33 |
Males and Females | 6-11 | 0.15-0.61 | 4.87-20.27 |
Males and Females | 12-19 | 0.31-0.99 | 9.80-31.11 |
Males and Females | 20-59 | 0.41-1.39 | 16.67-56.39 |
Males and Females | 60-79 | -- | 4.63-44.44 |
Males | 6-11 | 0.14-0.57 | F |
Males | 12-19 | 0.29-0.91 | F |
Males | 20-59 | 0.52-1.17 | 23.70-53.33 |
Males | 60-79 | 0.10-0.98 | X |
Females | 6-11 | 0.16-0.65 | F |
Females | 12-19 | 0.34-1.09 | 11.43-36.30 |
Females | 20-59 | 0.42-1.43 | 14.44-48.87 |
Females | 60-79 | -- | X |
Females | 13-49 | 0.48-1.62 | 17.78-60.15 |
Pregnant Women (P4) | less than 25-40+ | 0.47-1.60 | 16.92-57.10 |
Pregnant Women (MIREC) | less than 25- greater than or equal to 35 | 0.31-1.06 | 12.59-42.47 |
Children (MIREC CD Plus)b | 23-36 months | 0.22-0.34 | 7.11-10.67 |
Infants (P4) | 0-3 months old | 0.0178-0.687 | 0.338-13.07 |
Table Notes
(--) If greater than 40% of samples were below the LOD, the percentile distribution is reported but means were not calculated.
F = Data is too unreliable to be published.
X = Supressed to meet the confidentiality requirements of the Statistics Act
a Daily Dose = Specific Gravity Adjusted Urine Concentration (µg/L/kg) x Daily Urine Volume (L/day) / Urinary Excretion Fraction (FUE = 0.54).
b Preliminary results.
Gender | Age | Geometric Mean (95% confidence intervals) |
95th Percentile (95% confidence intervals) |
---|---|---|---|
Males and Females | 3-5 | 0.47 (0.39, 0.56) |
6.3 (4.3, 8.3) |
Males and Females | 6-11 | 0.32 (0.23, 0.44) |
11E (3.9, 17) |
Males and Females | 12-19 | 0.55 (0.41, 0.74) |
18E (9, 26) |
Males and Females | 20-59 | 0.61E (0.42, 0.89) |
25E (15, 35) |
Males and Females | 60-79 | 0.26 (0.21, 0.32) |
15E (6.8, 24) |
Males | 3-5 | 0.47 (0.38, 0.59) |
7.4E (3.9, 11) |
Males | 6-11 | 0.34E (0.22, 0.53) |
F |
Males | 12-19 | 0.6E (0.4, 0.91) |
F |
Males | 20-59 | 0.68E (0.41, 1.1) |
30E (15, 46) |
Males | 60-79 | 0.33E (0.22, 0.49) |
X |
Females | 3-5 | 0.46 (0.35, 0.61) |
4.8E (2.2, 7.5) |
Females | 6-11 | 0.29E (0.2, 0.44) |
F |
Females | 12-19 | 0.51E (0.35, 0.73) |
F |
Females | 20-59 | 0.55E (0.37, 0.81) |
20E (9.1, 31) |
Females | 60-79 | 0.21E (0.14, 0.32) |
X |
Females | 13-49 | 0.6E (0.4, 0.88) |
25E (11, 39) |
Table Notes
(--) If greater than 40% of samples were below the LOD, the percentile distribution is reported but means were not calculated.
E = Use data with caution.
F = Data is too unreliable to be published.
X = Supressed to meet the confidentiality requirements of the Statistics Act.
a Daily Dose = [Creatinine Adjusted Urine Concentration (µg/g Cr) x CER (g/day) ]/ [Body Weight (kg) x Urinary Excretion Fraction (FUE = 0.54)].
Appendix E. Unadjusted, Specific Gravity and Creatinine Adjusted Urinary Triclosan Concentrations
Statistics Canada (2013a) analysed the urinary triclosan data from the CHMS Cycle 2 (2009-2011). In order to perform these analyses, the CHMS Data Users Guide was used (Statistics Canada 2013b). Values below the limit of detection (LOD) were assumed to be LOD/2. The age categories were changed from what is presented in the Second Report on Biomonitoring (Health Canada 2013). Adults aged 20-59 were combined and an additional group of females aged 13-49, representing females of child-bearing age, was created similar to the approach taken in the preliminary assessment with the NHANES data. The P4 and MIREC data were analyzed by those involved in each project (refer to Arbuckle et al. 2015a, 2015b).
Gender | Age | N | Percent less than LODa | Geometric Mean (95% CI) |
95th Percentile (95% CI) |
---|---|---|---|---|---|
Males and Females | 3-79 | 2550 | 28.20 | 15 (12-19) | 710 (540-880) |
Males and Females | 3-5 | 523 | 29.45 | 8 (7-10) | 120E (68-160) |
Males and Females | 6-11 | 515 | 33.98 | 8 (6-10) | 250E (82-410) |
Males and Females | 12-19 | 510 | 19.02 | 19 (14-26) | 640E (400-870) |
Males and Females | 20-59 | 712 | 24.16 | 18E (12-27) | 770E (440-1100) |
Males and Females | 60-79 | 290 | 41.72 | -- | 590 (430-750) |
Males | 3-79 | 1274 | 26.77 | 17 (12-25) | 790E (350-1200) |
Males | 6-11 | 262 | 34.35 | 8E (5-12) | F |
Males | 12-19 | 254 | 18.11 | 19E (13-30) | F |
Males | 20-59 | 358 | 22.35 | 21E (12-36) | 960E (370-1600) |
Males | 60-79 | 141 | 36.88 | 12E (7-22) | X |
Females | 3-79 | 1276 | 29.62 | 13 (10-17) | 680E (410-960) |
Females | 6-11 | 253 | 33.60 | 7E (5-11) | F |
Females | 12- 9 | 256 | 19.92 | 18E (12-27) | 620E (370-870) |
Females | 20-59 | 354 | 25.99 | 16E (10-25) | 710E (430-990) |
Females | 60-79 | 149 | 46.31 | No data | X |
Females | 13-49 | 499 | 23.68 | 18E (12-29) | 720E (410-1000) |
Table Notes
(--) If greater than 40% of samples were below the LOD, the percentile distribution is reported but means were not calculated.
E = Use data with causion.
F = Data is too unreliable to be published.
X = Supressed to meet the confidentiality requirements of the Statistics Act.
Gender | Age | N | Percent less than LOD | Geometric Mean (95% CI) |
95th Percentile (95% CI) |
---|---|---|---|---|---|
Males and Females | 3-79 | 2550 | 28.20 | 22 (17-28) | 990 (790-1200) |
Males and Females | 3-5 | 523 | 29.45 | 10 (8.5-13) | 120E (49-190) |
Males and Females | 6-11 | 515 | 33.98 | 9.2 (6.9-12) | F |
Males and Females | 12-19 | 510 | 19.02 | 24 (17- 32) | 840E (440-1200) |
Males and Females | 2059 | 712 | 24.16 | 28E (18-42) | 1000 (870-1200) |
Males and Females | 60-79 | 290 | 41.72 | -- | 760E (460-1100) |
Males | 3-79 | 1274 | 26.77 | 23E (16-34) | 1100 (910-1200) |
Males | 6-11 | 262 | 34.35 | 8.8E (5.7-14) | 450E (140-760) |
Males | 12-19 | 254 | 18.11 | 23E (15-35) | 790E (26-1300) |
Males | 20-59 | 358 | 22.35 | 29E (16-53) | 1100 (820-1400) |
Males | 60-79 | 141 | 36.88 | 19E (12-30) | X |
Females | 3 -79 | 1276 | 29.62 | 21 (16-27) | 760 (550 - 970) |
Females | 6-11 | 253 | 33.60 | 9.7E (6.5-15) | F |
Females | 12-19 | 256 | 19.92 | 24E (16-36) | 940E (450-1400) |
Females | 20-59 | 354 | 25.99 | 27E (17-41) | 790E (400-1200) |
Females | 60-79 | 149 | 46.31 | -- | X |
Females | 13-49 | 499 | 23.68 | 19E (19-44) | 980E (480-1500) |
Table Notes
(--) If greater than 40% of samples were below the LOD, the percentile distribution is reported but means were not calculated.
E = Use date with caution.
F = Data is too unreliable to be published.
X = Supressed to meet the confidentiality requirements of the Statistics Act.
a The approach used to adjust the urinary concentrations using specific gravity was taken from Miller et al. (2004). SG Adjusted = Unadjusted x (SGref-1/SGsample-1) where SGref was assumed to be 1.024 for the CHMS data.
Gender | Age | N | Percent less than LOD | Geometric Mean (95% CI) |
95th Percentile (95% CI) |
---|---|---|---|---|---|
Males and Females | 3-79 | 2540 | 28.20 | 15 (12-19) | 620 (400-830) |
Males and Females | 3-5 | 522 | 29.45 | 14 (12-17) | 190 (140-250) |
Males and Females | 6-11 | 513 | 33.98 | 8.7 (6.4-12) | 270E (79-470) |
Males and Females | 12-19 | 508 | 19.02 | 14 (11-19) | 500E (290-710) |
Males and Females | 20-59 | 708 | 24.16 | 17E (12-26) | 720E (400-1000) |
Males and Females | 60-79 | 289 | 41.72 | -- | 600E (290-910) |
Males | 3-79 | 1270 | 26.77 | 15 (11-21) | 700E (360-1000) |
Males | 6 - 11 | 261 | 34.35 | 8.8E (5.6-14) | F |
Males | 12-19 | 253 | 18.11 | 14E (9.0-21) | 450E (220-690) |
Males | 20-59 | 357 | 22.35 | 17E (9.6 - 30) | 880E (390-1400) |
Males | 60-79 | 141 | 36.88 | 12E (7.5-18) | X |
Females | 3-79 | 1270 | 29.62 | 15 (11-19) | 570E (340-800) |
Females | 6-11 | 252 | 33.60 | 8.5E (5.6-13) | F |
Females | 12-19 | 255 | 19.92 | 15E (10-22) | 610E (280-950) |
Females | 20-59 | 351 | 25.99 | 18E (12-27) | 660E (340-980) |
Females | 60-79 | 148 | 46.31 | -- | X |
Females | 13-49 | 495 | 23.68 | 18E (12-28) | 710E (370-1100) |
Table Notes
(--) If greater than 40% of samples were below the LOD, the percentile distribution is reported but means were not calculated.
E = Use date with caution.
F = Data is too unreliable to be published.
X = Supressed to meet the confidentiality requirements of the Statistics Act.
Study | Population | Type | Age | Na | Percent less than LOD | Geometric Mean (95% CI) |
95th Percentile |
---|---|---|---|---|---|---|---|
P4 | Pregnant Women | Unadjusted | less than 25-40+ | 1247 | 16.4 | 21.61 (18.17-25.71) |
833.4 (740.7-918.1) |
P4 | Pregnant Women | SG-Adjustedb | less than 25-40+ | 1247 | 13.2 | 22.9 (19.2-27.2) |
774.9 (673.6-880.8) |
P4 | Infants | Unadjusted | 0-3 months | 100 | 39.0 | 2.8 (1.6-4.9) | 52.0 (22.7-100.0) |
P4 | Infants | SG-Adjusted | 0-3 months | 98 | 24 | 2.5 (1.5-4.4) | 53.4 (35.2-229.8) |
MIREC | Pregnant Women | Unadjusted | less than 25- greater than or equal to 35 | 1861 | 0.6 | 12.64 (11.38-14.03) |
697.58 |
MIREC | Pregnant Women | SG-Adjusted | less than 25- greater than or equal to 35 | 1858 | 0.6 | 14.36 (13.01-15.85) |
571.10 |
Table Notes
a For P4 Study, "N" refers to number of urine samples. For MIREC Study, "N" refers to number of individual participant.
b The approach used to adjust the urinary concentrations using specific gravity was SG Adjusted = Unadjusted x (SGref-1/SGsample-1) where SGref was equal to the median of the cohort.
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