m-toluidinium chloride

Carcinogenicity

Administrative data

Endpoint:

carcinogenicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

publication

Title:

Screening-level hazard characterization: Monocyclic aromatic amines category

Author:

U.S. Environmental Protection Agency

Year:

2009

Bibliographic source:

U.S. Environmental Protection Agency, September 2009, pp1-32

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

25 SD rats (sex unspecified) were administerd with 8,000 ppm and 16,000 ppm (400 mg/kg bw and 800 mg/kg bw, respectively) m-toluidine HCl for 13 weeks; then with 4,000 ppm and 8,000 ppm (200 mg/kg bw and 400 mg/kg bw, respectivly) for 65 weeks.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

m-toluidinium chloride

EC Number:

211-314-4

EC Name:

m-toluidinium chloride

Cas Number:

638-03-9

Molecular formula:

C7H9N.ClH

IUPAC Name:

3-methylanilinium chloride

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

not specified

Details on test animals or test system and environmental conditions:

25 SD rats per dose

Administration / exposure

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Duration of treatment / exposure:

13 weeks with 400 mg/kg bw and 800 mg/kg bw;
65 weeks with 200 mg/kg bw and 400 mg/kg bw

Frequency of treatment:

once daily

No. of animals per sex per dose:

25 animals, sex unspecified

Control animals:

not specified

Details on study design:

25 Sprague-Dawley rats per dose group (sex unspecified) were administered m-toluidine HCl in the diet at 8,000 and 16,000 ppm (400 and 800 mg/kg bw/d) for 13 weeks, then 4000 and 8,000 ppm (200 and 400 mg/kg bw/d) for 65 weeks. A greater than 10% reduction in body weight gain and death was observed at 400 and 800 mg/kg bw/d following 13 weeks, therefore the dosages were reduced to 200 and 400 mg/kg bw/d for the remaining 65 weeks.

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

mortality observed, treatment-related

Description (incidence):

A greater than 10% reduction in body weight gain and death was observed at 400 and 800 mg/kg bw/d following 13 weeks, therefore the dosages were reduced to 200 and 400 mg/kg bw/d for the remaining 65 weeks.

Body weight and weight changes:

effects observed, treatment-related

Description (incidence and severity):

A greater than 10% reduction in body weight gain and death was observed at 400 and 800 mg/kg bw/d following 13 weeks, therefore the dosages were reduced to 200 and 400 mg/kg bw/d for the remaining 65 weeks.

Food consumption and compound intake (if feeding study):

not specified

Relevance of carcinogenic effects / potential:

After reduction of dosage, no increase in tumours was observed. There was no evidence of carcinogenicity in this assay.

Effect levels

Key result

Dose descriptor:

dose level: mg/kg bw

Effect level:

>= 200 - <= 400 mg/kg diet

Based on:

not specified

Sex:

not specified

Basis for effect level:

other: no tumour development was observed

Remarks on result:

other: Effect typs: carcinogenicity

Applicant's summary and conclusion

Conclusions:

In a chronic toxicity study, 25 Sprague-Dawley rats per dose group (sex unspecified) were administered m-toluidine HCl in the diet at 8,000 and 16,000 ppm (400 and 800 mg/kg bw/d) for 13 weeks, then 4000 and 8,000 ppm (200 and 400 mg/kg bw/d) for 65 weeks. A greater than 10% reduction in body weight gain and death was observed at 400 and 800 mg/kg bw/d following 13 weeks, therefore the dosages were reduced to 200 and 400 mg/kg bw/d for the remaining 65 weeks. No increase in tumours was observed. There was no evidence of carcinogenicity in this assay.

Executive summary:

In a chronic toxicity study, 25 Sprague-Dawley rats per dose group (sex unspecified) were administered m-toluidine HCl in the diet at 8,000 and 16,000 ppm (400 and 800 mg/kg bw/d) for 13 weeks, then 4000 and 8,000 ppm (200 and 400 mg/kg bw/d) for 65 weeks. A greater than 10% reduction in body weight gain and death was observed at 400 and 800 mg/kg bw/d following 13 weeks, therefore the dosages were reduced to 200 and 400 mg/kg bw/d for the remaining 65 weeks. No increase in tumours was observed. No other details were provided. There was no evidence of carcinogenicity in this assay.

No information on the TG is given. As the information has been published by the EPA and is publicly available, the study has been rated as Klimisch 2.

m-toluidine HCl is not classified as carcinogetic.