Follow-up assessment report on aniline: tables

Tables

Table 1: Upper-bounding Estimates of Daily Intake of Aniline by the General Population in Canada by Various Age Groups (µg/kg-bw per day)

Route of Exposure	0 - 0.5 yr^Footnote a Breast Milk Fed^Footnote b	0 - 0.5 yr^Footnote a Formula Fed^Footnote c	0 - 0.5 yr^Footnote a Fed Solid Food^Footnote d	0.5 - 4 yr^Footnote e	5 - 11 yr^Footnote f	12 - 19 yr^Footnote g	20 - 59 yr^Footnote h	60 + yr^Footnote i
Ambient Air^Footnote j	<0.001	<0.001	<0.001	0.001	0.001	<0.001	<0.001	<0.001
Indoor Air^Footnote k	0.013	0.013	0.013	0.028	0.022	0.013	0.011	0.009
Drinking Water^Footnote l	na	0.053	0.050	0.023	0.018	0.010	0.011	0.011
Food and Beverages^Footnote m	0.520	nd	0.667	1.11	0.924	0.384	0.252	0.200
Soil^Footnote n	0.001	0.001	0.001	0.002	<0.001	<0.001	<0.001	<0.001
Total Intake	0.535	0.068	0.732	1.16	0.965	0.407	0.274	0.221

Maximum Total Intake from All Routes of Exposure - Upper-Bounding: 1.16 (µg/kg-bw per day)

Abbreviations: na = not applicable nd = no data

Footnotes

Footnote a

Assumed to weigh 7.5 kg, to breathe 2.1 m³ of air per day, to drink 0.8 L of water per day (formula fed) or 0.3 L/day (fed solid food) or 0.0 L/day (breast fed) and to ingest 30 mg of soil per day (Health Canada, 1998).

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Footnote b

Based on the highest measured concentration of aniline, 5.2 ppb in 31 samples of breast milk from women residing in Ontario (DeBruin et al., 1999), a daily consumption of 750 g breast milk per day for infants and the assumption that infants in Canada are exclusively breast-fed (Health Canada, 1998).

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Footnote c

For exclusively formula-fed infants, intake of water is only that required to reconstitute formula. Based on the limit of detection of 0.5 µg/L reported in a survey of drinking water conducted in 1991 in 17 municipalities in Quebec, in which aniline was not detected (St Martin, 1992).

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Footnote d

The dietary intake is based on consumption of 0.3 litres of water and up to 1.18 kg of food daily. This intake pattern is presented as a hypothetical extreme case and does not reflect recommended infant feeding practice.

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Footnote e

Assumed to weigh 15.5 kg, to breathe 9.3 m³ of air per day, to drink 0.7 L of water per day and to ingest 100 mg of soil per day (Health Canada, 1998).

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Footnote f

Assumed to weigh 31.0 kg, to breathe 14.5 m³ of air per day, to drink 1.1 L of water per day and to ingest 65 mg of soil per day (Health Canada, 1998).

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Footnote g

Assumed to weigh 59.4 kg, to breathe 15.8 m³ of air per day, to drink 1.2 L of water per day and to ingest 30 mg of soil per day (Health Canada, 1998).

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Footnote h

Assumed to weigh 70.9 kg, to breathe 16.2 m³ of air per day, to drink 1.5 L of water per day and to ingest 30 mg of soil per day (Health Canada, 1998).

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Footnote i

Assumed to weigh 72.0 kg, to breathe 14.3 m³ of air per day, to drink 1.6 L of water per day and to ingest 30 mg of soil per day (Health Canada, 1998).

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Footnote j

Based on the higher mean level of aniline (0.012 µg/m³) in ambient air reported by Zhu and Aikawa 2004 in two regions of eastern Ontario and an estimated 3 hours per day spent outdoors (Health Canada, 1998).

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Footnote k

Based on the highest reported concentration of aniline (0.054 µg/m³) in the indoor air of 69 homes in two different locations in eastern Ontario (Zhu and Aikawa, 2004) and an estimated 21 hours per day spent indoors (Health Canada, 1998).

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Footnote l

Based on the limit of detection of 0.5 µg/L reported in a survey of drinking water conducted in 1991 in 17 municipalities in Quebec, in which aniline was not detected (St Martin, 1992).

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Footnote m

Based on the maximum measured concentrations of aniline in raw apples (0.483 mg/kg), and the detection limit of 0.010 mg/kg for other fruits and vegetables tested from Canada (Cao et al. 2009). For canned apple products, a concentration of 0.483 mg/kg was used and for apple pie, a concentration of 0.160 mg/kg was used. The highest concentrations of aniline measured in soft drinks and the concentration of aniline in hard candies were used (Lancaster and Lawrence, 1992). The data set considered includes reports by Neurath et al., 1977, by Yu and Wu 1989, and by Hernando et al., 1999. For breast milk-fed babies, see footnote B. Amounts of foods consumed on a daily basis by each age group are described by Health Canada (Health Canada, 1998).

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Footnote n

Based on the limit of detection (0.3 mg/kg) of aniline in a survey of agricultural soil from nine provinces in Canada in which aniline was not detected (Webber and Wang, 1995).

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Table 1a: Average Estimates of Daily Intake of Aniline by the General Population in Canada by Various Age Groups (µg/kg-bw per day)

Route of Exposure	0 - 0.5 yr^{Footnote a.1} Breast Milk Fed^{Footnote b.1}	0 - 0.5 yr^{Footnote a.1} Formula Fed^{Footnote c.1}	0 - 0.5 yr^{Footnote a.1} Fed Solid Food^{Footnote d.1}	0.5 - 4 yr^{Footnote e.1}	5 - 11 yr^{Footnote f.1}	12 - 19 yr^{Footnote g.1}	20 - 59 yr^{Footnote h.1}	60 + yr^{Footnote i.1}
Ambient Air^{Footnote j.1}	<0.001	<0.001	<0.001	0.001	0.001	<0.001	<0.001	<0.001
Indoor Air^{Footnote k.1}	0.003	0.003	0.003	0.006	0.005	0.003	0.002	0.002
Drinking Water^{Footnote l.1}	na	0.053	0.050	0.023	0.018	0.010	0.011	0.011
Food and Beverages^{Footnote m.1}	0.036	nd	0.501	0.690	0.566	0.241	0.169	0.139
Soil^{Footnote n.1}	0.001	0.001	0.001	0.002	<0.001	<0.001	<0.001	<0.001
Total Intake	0.040	0.058	0.556	0.722	0.590	0.254	0.182	0.152

Maximum Total Intake from All Routes of Exposure - Central Tendency: 0.722 (µg/kg-bw per day)

Abbreviations: na = not applicable nd = no data

Footnotes

Footnote a.1

Return to footnotea.1 Referrer

Footnote b.1

Based on the mean concentration of aniline, 0.36 ppb in 31 samples of breast milk from women residing in Ontario (DeBruin et al., 1999), a daily consumption of 750 g breast milk per day for infants and the assumption that infants in Canada are exclusively breast-fed (Health Canada, 1998).

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Footnote c.1

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Footnote d.1

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Footnote e.1

Assumed to weigh 15.5 kg, to breathe 9.3 m³ of air per day, to drink 0.7 L of water per day and to ingest 100 mg of soil per day (Health Canada, 1998).

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Footnote f.1

Assumed to weigh 31.0 kg, to breathe 14.5 m³ of air per day, to drink 1.1 L of water per day and to ingest 65 mg of soil per day (Health Canada, 1998).

Return to footnotef.1 Referrer

Footnote g.1

Assumed to weigh 59.4 kg, to breathe 15.8 m³ of air per day, to drink 1.2 L of water per day and to ingest 30 mg of soil per day (Health Canada, 1998).

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Footnote h.1

Assumed to weigh 70.9 kg, to breathe 16.2 m³ of air per day, to drink 1.5 L of water per day and to ingest 30 mg of soil per day (Health Canada, 1998).

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Footnote i.1

Assumed to weigh 72.0 kg, to breathe 14.3 m³ of air per day, to drink 1.6 L of water per day and to ingest 30 mg of soil per day (Health Canada, 1998).

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Footnote j.1

Based on the overall mean reported concentration of aniline (0.011 µg/m³) in ambient air reported by Zhu and Aikawa 2004 in two regions of eastern Ontario and an estimated 3 hours per day spent outdoors (Health Canada, 1998).

Return to footnotej.1 Referrer

Footnote k.1

Based on the overall mean reported concentration of aniline (0.011 µg/m³) in the indoor air of 62 homes in two different locations in eastern Ontario in which cigarette smoking did not occur (Zhu and Aikawa, 2003) and an estimated 21 hours per day spent indoors (Health Canada, 1998).

Return to footnotek.1 Referrer

Footnote l.1

Based on the limit of detection of 0.5 µg/L reported in a survey of drinking water conducted in 1991 in 17 municipalities in Quebec, in which aniline was not detected (St Martin, 1992).

Return to footnotel.1 Referrer

Footnote m.1

Based on the mean reported concentration of aniline in composite samples of raw apple in which aniline was detected (0.277 mg/kg), and the detection limit of 0.010 mg/kg for other fruits and vegetables tested from Canada (Cao et al. 2009). For canned apple products, a concentration of 0.277 mg/kg was used and for apple pie, a concentration of 0.092 mg/kg was used. The mean concentrations of aniline measured in soft drinks and the concentration of aniline in hard candies were used (Lancaster and Lawrence, 1992). The data set considered includes reports by Neurath et al., 1977, by Yu and Wu 1989, and by Hernando et al., 1999. For breast milk-fed babies, see footnote 2. Amounts of foods consumed on a daily basis by each age group are described by Health Canada (Health Canada, 1998).

Return to footnotem.1 Referrer

Footnote n.1

Based on the limit of detection (0.3 mg/kg) of aniline in a survey of agricultural soil from nine provinces in Canada in which aniline was not detected (Webber and Wang, 1995).

Return to footnoten.1 Referrer

Table 2: Consumer Product Exposure Scenarios

Consumer Product	Scenario	Estimated intake
Marker pen Acute^{Footnote a.2} exposure	Child marking skin with ink. Exposed area is 50 cm²; ink transferred to 50 cm² is 0.05 grams. Concentration of aniline in ink is 0.022 % (Hansen et al. 2008). Assume 100% absorption by ingestion after mouth contact with the inked skin. Aniline intake per event: 50 mg ink * 10E3 µg/mg*0.00022 g aniline per g ink /15.5 kg = 0.71 µµg/kg-bw/event	0.71 µg/kg-bw/event
Marker pen Chronic^{Footnote a.2} exposure	Child marking skin with ink. Exposed area is a 25 cm line; ink transferred to 25 cm is 3.35 mg. Concentration of aniline in ink is 0.022 % (Hansen et al. 2008) and ink deposition rate is 134 µg/cm (ACMI 2009). Assume 100% absorption by ingestion after mouth contact with the inked skin. Aniline intake per event: 3.35 mg ink 10E3 µg/mg 0.00022 g aniline per g ink /15.5 kg = 0.047 µg/kg-bw/event Assume child uses marker pens daily.	0.047 µg/kg-bw/day
Polyamide cooking utensils	Preparation of soups and sauces using polyamide tools with aniline migration rate of 30 µg/litre/hour (Kantonales Laboratorium 2006). Assume that the utensil remains in the soup or sauce for one hour at 100 degrees Celsius. Using a detailed intake of foods (Health Canada, 1998), the estimated exposure to aniline arising from use of polyamide utensil from which aniline migrates to soups and sauces only, is Age: 0 - 6 mo (0.053 µg/kg-bw/day) Age: 6 mo - 4 yr (0.14 µg/kg-bw/day) Age: 5 - 11 yr (0.079 µg/kg-bw/day) Age: 12-19 yr (0.044 µg/kg-bw/day) Age: 20-59 yr (0.042 µg/kg-bw/day) Age: 60 + yr (0.04 µg/kg-bw/day)	0.04 to 0.14 µg/kg-bw/day

Consumer Product

Scenario

Estimated intake

Marker pen

Acute^{Footnote a.2} exposure

Child marking skin with ink.

Exposed area is 50 cm²; ink transferred to 50 cm² is 0.05 grams. Concentration of aniline in ink is 0.022 % (Hansen et al. 2008).

Assume 100% absorption by ingestion after mouth contact with the inked skin.

Aniline intake per event:

50 mg ink * 10E3 µg/mg*0.00022 g aniline per g ink /15.5 kg = 0.71 µµg/kg-bw/event

0.71

µg/kg-bw/event

Marker pen

Chronic^{Footnote a.2} exposure

Child marking skin with ink.

Exposed area is a 25 cm line; ink transferred to 25 cm is 3.35 mg. Concentration of aniline in ink is 0.022 % (Hansen et al. 2008) and ink deposition rate is 134 µg/cm (ACMI 2009).

Assume 100% absorption by ingestion after mouth contact with the inked skin.

Aniline intake per event:

3.35 mg ink *10E3 µg/mg *0.00022 g aniline per g ink /15.5 kg = 0.047 µg/kg-bw/event

Assume child uses marker pens daily.

0.047

µg/kg-bw/day

Polyamide cooking utensils

Preparation of soups and sauces using polyamide tools with aniline migration rate of 30 µg/litre/hour (Kantonales Laboratorium 2006). Assume that the utensil remains in the soup or sauce for one hour at 100 degrees Celsius. Using a detailed intake of foods (Health Canada, 1998), the estimated exposure to aniline arising from use of polyamide utensil from which aniline migrates to soups and sauces only, is

Age: 0 - 6 mo (0.053 µg/kg-bw/day)
Age: 6 mo - 4 yr (0.14 µg/kg-bw/day)
Age: 5 - 11 yr (0.079 µg/kg-bw/day)
Age: 12-19 yr (0.044 µg/kg-bw/day)
Age: 20-59 yr (0.042 µg/kg-bw/day)
Age: 60 + yr (0.04 µg/kg-bw/day)

0.04 to 0.14

µg/kg-bw/day

Table 3 (Males): Tumourigenic Doses (TD₀₅s and TDL₀₅s) for Aniline Based on the Incidence of Splenic Tumours in Male and Female CD-F Rats (CIIT, 1982)

Tumour type	Aniline dose (mg/kg-bw per day)	Tumour incidence	TD₀₅ (TDL₀₅) (mg/kg-bw per day)	Parameter estimates
Stromal sarcoma	0	0/123	46 (35)	Chi-square = 0.08 Degrees of freedom = 1 p-value = 0.78
Stromal sarcoma	7.2	0/129	46 (35)	Chi-square = 0.08 Degrees of freedom = 1 p-value = 0.78
Stromal sarcoma	21.6	1/128	46 (35)	Chi-square = 0.08 Degrees of freedom = 1 p-value = 0.78
Stromal sarcoma	71.9	21/130	46 (35)	Chi-square = 0.08 Degrees of freedom = 1 p-value = 0.78
Hemangiosarcoma	0	0/123	75 (61)	Chi-square = 0.17 Degrees of freedom = 2 p-value = 0.92
Hemangiosarcoma	7.2	0/129	75 (61)	Chi-square = 0.17 Degrees of freedom = 2 p-value = 0.92
Hemangiosarcoma	21.6	0/128	75 (61)	Chi-square = 0.17 Degrees of freedom = 2 p-value = 0.92
Hemangiosarcoma	71.9	6/130	75 (61)	Chi-square = 0.17 Degrees of freedom = 2 p-value = 0.92
Fibrosarcoma	0	0/123	94 (72)	Chi-square = 0.08 Degrees of freedom = 2 p-value = 0.95
Fibrosarcoma	7.2	0/129	94 (72)	Chi-square = 0.08 Degrees of freedom = 2 p-value = 0.95
Fibrosarcoma	21.6	0/128	94 (72)	Chi-square = 0.08 Degrees of freedom = 2 p-value = 0.95
Fibrosarcoma	71.9	3/130	94 (72)	Chi-square = 0.08 Degrees of freedom = 2 p-value = 0.95
Osteogenic sarcoma	0	0/123	94 (72)	Chi-square = 0.08 Degrees of freedom = 2 p-value = 0.96
Osteogenic sarcoma	7.2	0/129	94 (72)	Chi-square = 0.08 Degrees of freedom = 2 p-value = 0.96
Osteogenic sarcoma	21.6	0/128	94 (72)	Chi-square = 0.08 Degrees of freedom = 2 p-value = 0.96
Osteogenic sarcoma	71.9	3/130	94 (72)	Chi-square = 0.08 Degrees of freedom = 2 p-value = 0.96
Capsular sarcoma	0	0/123	136 (89)	Chi-square = 0.03 Degrees of freedom = 2 p-value = 0.98
Capsular sarcoma	7.2	0/129	136 (89)	Chi-square = 0.03 Degrees of freedom = 2 p-value = 0.98
Capsular sarcoma	21.6	0/128	136 (89)	Chi-square = 0.03 Degrees of freedom = 2 p-value = 0.98
Capsular sarcoma	71.9	1/130	136 (89)	Chi-square = 0.03 Degrees of freedom = 2 p-value = 0.98

Table 3 (Females): Tumourigenic Doses (TD₀₅s and TDL₀₅s) for Aniline Based on the Incidence of Splenic Tumours in Female CD-F Rats (CIIT, 1982)

Tumour type	Aniline dose (mg/kg-bw per day)	Tumour incidence	TD₀₅ (TDL₀₅) (mg/kg-bw per day)	Parameter estimates
Hemangiosarcoma	0	0/129	136 (89)	Chi-square = 0.03 Degrees of freedom = 2 p-value = 0.99
Hemangiosarcoma	7.2	0/129	136 (89)	Chi-square = 0.03 Degrees of freedom = 2 p-value = 0.99
Hemangiosarcoma	21.6	0/130	136 (89)	Chi-square = 0.03 Degrees of freedom = 2 p-value = 0.99
Hemangiosarcoma	71.9	1/130	136 (89)	Chi-square = 0.03 Degrees of freedom = 2 p-value = 0.99

Table 4 (In vivo): Summary of Genotoxicity Data of Aniline (Based on Information Identified After June 1993)

Species, Strain, Sex etc.	Endpoint	Dose, route of exposure etc.	Results	Reference
ddY mouse and Wistar rat; male; 4/group	DNA damage (Comet Assay)	Mouse - single oral dose of aniline (100 mg/kg)	Positive - DNA damage in the colon, liver, urinary bladder, lung, brain, and bone marrow.	Sekihashi et al., 2002.
ddY mouse and Wistar rat; male; 4/group	DNA damage (Comet Assay)	Rat - single oral dose (150 mg/kg)	Positive - DNA damage in the stomach, colon, liver, kidney, urinary bladder and lung.	Sekihashi et al., 2002.
Mouse ddY male	DNA damage (Comet assay)	Single oral dose of aniline (1000 mg/kg)	Positive - DNA damage in liver, bladder, lung, brain, bone marrow Spleen was not investigated.	Sasaki et al., 1999.
Mouse (strain not identified in secondary source)	Chromosomal aberration assay	Intraperitoneal; 220, 300, 380 mg/kg; twice; 24 hour interval. Sampling: 16, 20 and 24 hours after second treatment.	Negative in mouse bone marrow cells. All doses induced clinical symptoms, no cytotoxic effects were induced.	Bayer AG, 2001b, cited in ECB, 2004.
Mouse; CBA; male; 5/group	Chromosomal aberration.	Intraperitoneal 220, 300, 380 mg/kg of Aniline HCl (equivalent to aniline base; two doses separated by a 24-hour interval.	Negative.	Jones and Fox, 2003.
Mouse; B6C3F1; male; 5/group	Micronucleus induction (bone marrow)	Oral; 12, 23, 47, 120 and 470 mg/kg of aniline in corn oil; gavage; two doses; 24-hour Interval	Weak positive response (increase in micronuclei polychromatic erythrocytes in 23 or 470 mg/kg groups, but not well correlated with dose).	Ress et al., 2002.
Rat (strain not identified)	Micronucleus induction (bone marrow)	Single oral dose 500 mg/kg; sampling done at 48 hours.	Negative.	Bayer AG, 2001a, cited in ECB, 2004.
Rat; PVG; male; 7/group	Micronucleus Induction (bone marrow) Study in compliance with OECD principles of GLP (revised 1997).	Single oral dose of aniline HCl (equivalent to 0, 300, 400 and 500 mg/kg-bw of aniline base). (samples obtained 24 and 48 hours after treatment).	Positive - dose-related induction of micronuclei observed at the 24-hour sampling time, but not following 48-hour.	Bomhard, 2003.
Mouse; B6C3F1; male and female	Micronucleus Induction (peripheral blood)	Oral; 500, 1000 and 2000 ppm aniline HCl; 90 days.	Positive (in males and females) in polychromatic and normochromatic erythrocytes.	Witt et al., 2000.

Table 4 (In vitro): Summary of Genotoxicity Data of Aniline (Based on Information Identified After June 1993)

Species, Strain, Sex etc.	Endpoint	Dose, route of exposure etc.	Results	Reference
Escherichia coli IC203 and IC188	Mutagenicity (WP2 Mutoxitest)	Aniline HCl; 1000 µg/plate	Negative	Martínez et al., 2000.
Salmonella typhimurium (TA 98, 100)	Ames test	Aniline; 317, 325, 1250, 2500, 5000 µg/plate	Negative	Aßmann et al., 1997.
Salmonella typhimurium (TA 98, 100)	Ames test	Aniline; 1, 10, 30, 100, 300, 1000, 3000 µg/plate	Negative (with or without S9 mix)	Chung et al., 1995; 1996.
Sacchromyces cerevisiae (strain, RS112)	DEL recombinagenic activity) (generation of oxidative free radical species)	Aniline; 0, 5, 10, 12 mg/mL	Induction of recombination only at 12 mg/mL	Brennan and Schiestl, 1997.
Chinese hamster ovary cells (CHO)	Chromosomal aberrations	Aniline; 444, 888, 1176, 2664 µg/mL	Positive (in the absence of hepatic activation system).	Chung et al., 1995; 1996.
Chinese hamster lung cell line (CHL/IU)	Chromosomal aberrations	Aniline; 500, 1000, 1500, 2000, 2500 µg/mL	Positive	Matsushima et al., 1999.

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