Final Assessment

Appendicies

Appendix A. Triclosan Products Registered under the Pest Control Products Act

Appendix A-1. Toxicological Endpoints for Triclosan Health Risk Assessments
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.

Table B-1. Unadjusted urinary triclosan concentrations (µg/L/kg) for Canadians aged 3 to 79 years of age (Statistics Canada 2013a)
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

Table B-2. Specific gravity adjusted urinary triclosan concentrations (µg/L/kg) for Canadians aged 3 to 79 years of age (Statistics Canada 2013a)
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

Table B-3. Creatinine adjusted urinary triclosan concentrations (µg/g creatinine/kg) for Canadians aged 3 to 79 years of age (Statistics Canada 2013a)
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

Table B-4. Unadjusted and specific gravity (SG) adjusted urinary triclosan concentrations (µg/L/kg) for Canadian pregnant women from the P4 and MIREC Studies and for infants from the P4 Study (Arbuckle et al. 2015a, 2015b)
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

Table C-1. 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

Table D-1. Estimated daily dose (µg/kg bw per day) for Canadians aged 0 to 79 years of age using the unadjusted urinary concentrations (ug/L) per kg body weight (Statistics Canada 2013a, Arbuckle et al. 2014a,b) a
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).

Table D-2. Estimated daily dose (µg/kg bw per day) for Canadians aged 0 to 79 years of age using the specific gravity adjusted urinary concentrations (ug/L) per kg body weight (Statistics Canada 2013a, Arbuckle et al. 2014a,b, Personal Communication September 2014, Health Canada) a
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.

Table D-3. Estimated daily dose (µg/kg bw) for Canadians aged 3 to 79 years of age using the Mage equations described in Huber et al. (2011) to predict the creatinine excretion rate (CER) for each CHMS participant, then using the CER to compute the daily dose 1 (2014 personal communication from Environmental and Radiation Health Sciences Directorate, Health Canada, to Existing Substances Risk Assessment Bureau, Health Canada; unreferenced). a
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).

Table E-1. Unadjusted urinary triclosan concentrations (µg/L) for Canadians aged 3 to 79 years of age (Statistics Canada 2013a)
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.

Table E-2. Specific gravity adjusted urinary triclosan concentrations (µg/L) for Canadians aged 3 to 79 years of age (Statistics Canada 2013a) a
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.

Table E-3. Creatinine adjusted urinary triclosan concentrations (µg/g creatinine) for Canadians aged 3 to 79 years of age (Statistics Canada 2013a)
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.

Table E-4. Unadjusted and specific-gravity (SG) adjusted urinary triclosan concentrations (µg/L) for Canadian pregnant women from the P4 and MIREC studies and infants (0 to 3 months old) (Arbuckle et al. 2015a, 2015b)
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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