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 yrFootnote a

Breast Milk FedFootnote b
0 - 0.5 yrFootnote a

Formula FedFootnote c
0 - 0.5 yrFootnote a

Fed Solid FoodFootnote d
0.5 - 4 yrFootnote e 5 - 11 yrFootnote f 12 - 19 yrFootnote g 20 - 59 yrFootnote h 60 + yrFootnote i
Ambient AirFootnote j <0.001 <0.001 <0.001 0.001 0.001 <0.001 <0.001 <0.001
Indoor AirFootnote k 0.013 0.013 0.013 0.028 0.022 0.013 0.011 0.009
Drinking WaterFootnote l na 0.053 0.050 0.023 0.018 0.010 0.011 0.011
Food and BeveragesFootnote m 0.520 nd 0.667 1.11 0.924 0.384 0.252 0.200
SoilFootnote 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

 

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 yrFootnote a.1

Breast Milk FedFootnote b.1
0 - 0.5 yrFootnote a.1

Formula FedFootnote c.1
0 - 0.5 yrFootnote a.1

Fed Solid FoodFootnote d.1
0.5 - 4 yrFootnote e.1 5 - 11 yrFootnote f.1 12 - 19 yrFootnote g.1 20 - 59 yrFootnote h.1 60 + yrFootnote i.1
Ambient AirFootnote j.1 <0.001 <0.001 <0.001 0.001 0.001 <0.001 <0.001 <0.001
Indoor AirFootnote k.1 0.003 0.003 0.003 0.006 0.005 0.003 0.002 0.002
Drinking WaterFootnote l.1 na 0.053 0.050 0.023 0.018 0.010 0.011 0.011
Food and BeveragesFootnote m.1 0.036 nd 0.501 0.690 0.566 0.241 0.169 0.139
SoilFootnote 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

 

Table 2: Consumer Product Exposure Scenarios

Consumer Product Scenario Estimated intake

Marker pen

AcuteFootnote 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

ChronicFootnote 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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