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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Justification for type of information:
As m-toluidine hydrochloride dissociates into m-toluidine and hydrochloride the studies concerning the ecotoxicology of m-toludine are considered relevant for the registration according to REACH.

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:
Sprague-Dawley rats (13/sex/dose) were administered m-toluidine via gavage at 0, 30, 100 and 300 mg/kg bw/d; males for 42 d, and females from 2 weeks prior to mating to day 3 of lactation (41-53 d)
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
m-toluidine
EC Number:
203-583-1
EC Name:
m-toluidine
Cas Number:
108-44-1
Molecular formula:
C7H9N
IUPAC Name:
m-toluidine
Test material form:
not specified

Test animals

Species:
rat
Strain:
Sprague-Dawley
Details on test animals or test system and environmental conditions:
13/sex/dose

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Remarks on MMAD:
not specified
Details on exposure:
not specified
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
not specified
Duration of treatment / exposure:
males: 52 d
females: 41-53 days
Frequency of treatment:
once daily
Duration of test:
not specified
Doses / concentrationsopen allclose all
Dose / conc.:
300 mg/kg bw/day (actual dose received)
Dose / conc.:
100 mg/kg bw/day (actual dose received)
Dose / conc.:
30 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
13
Control animals:
not specified
Details on study design:
In a combined repeated-dose/reproductive/developmental toxicity screening test, Sprague-Dawley rats (13/sex/dose) were administered m-toluidine via gavage at 0, 30, 100 and 300 mg/kg bw/d; males for 42 d, and females from 2 weeks prior to mating to day 3 of lactation (41-53 d).

Examinations

Maternal examinations:
not specified
Ovaries and uterine content:
not specified
Blood sampling:
not specified
Fetal examinations:
not specified
Statistics:
not specified
Indices:
not specified
Historical control data:
not specified

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
Signs of developmental toxicity included an increase incidence of pup deaths at 30 and 100 mg/kg bw/d; however, the authors attributed the pup mortality a result of lack of nursing activity in the dams. All surviving offspring at 30 and 100 mg/kg bw/d developed normally during the 4-d lactation observation period.
Mortality:
mortality observed, treatment-related
Description (incidence):
pup deaths at 30 and 100 mg/kg bw/d; however, the authors attributed the pup mortality a result of lack of nursing activity in the dams. All surviving offspring at 30 and 100 mg/kg bw/d developed normally during the 4-d lactation observation period.
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Endocrine findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not examined
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Other effects:
not examined

Maternal developmental toxicity

Number of abortions:
not specified
Pre- and post-implantation loss:
effects observed, treatment-related
Description (incidence and severity):
implantation losses observed in all animals at 300 mg/kg bw/d and in 2/10 animals at 100 mg/kg bw/d
Total litter losses by resorption:
not examined
Early or late resorptions:
not specified
Dead fetuses:
not specified
Changes in pregnancy duration:
not specified
Changes in number of pregnant:
not specified
Other effects:
not examined
Details on maternal toxic effects:
not specified

Effect levels (maternal animals)

open allclose all
Key result
Dose descriptor:
LOAEL
Effect level:
> 30 - <= 100 mg/kg bw/day (actual dose received)
Based on:
not specified
Basis for effect level:
other: not specified
Key result
Dose descriptor:
NOAEL
Effect level:
<= 30 mg/kg bw/day (actual dose received)
Based on:
not specified
Basis for effect level:
other: not specified

Maternal abnormalities

Key result
Abnormalities:
not specified

Results (fetuses)

Fetal body weight changes:
not specified
Reduction in number of live offspring:
not examined
Changes in sex ratio:
not examined
Changes in litter size and weights:
not specified
Anogenital distance of all rodent fetuses:
not examined
Changes in postnatal survival:
not specified
External malformations:
not specified
Skeletal malformations:
not specified
Visceral malformations:
not specified
Other effects:
not examined
Details on embryotoxic / teratogenic effects:
not specified

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
30 mg/kg bw/day (actual dose received)
Based on:
not specified
Sex:
not specified
Basis for effect level:
other: not specified

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Key result
Developmental effects observed:
no
Lowest effective dose / conc.:
300 mg/kg bw/day (actual dose received)
Treatment related:
no

Applicant's summary and conclusion

Conclusions:
Signs of developmental toxicity included an increase incidence of pup deaths at 30 and 100 mg/kg bw/d; however, the authors attributed the pup mortality a result of lack of nursing activity in the dams. All surviving offspring at 30 and 100 mg/kg bw/d developed normally during the 4-d lactation observation period.

A LOAEL at 100 mg/kg bw/d and a NOAEL at 30 mg/kg bw/d has been assessed.
Executive summary:

In a combined repeated-dose/reproductive/developmental toxicity screening test, Sprague-Dawley rats (13/sex/dose) were administered m-toluidine via gavage at 0, 30, 100 and 300 mg/kg bw/d; males for 42 d, and females from 2 weeks prior to mating to day 3 of lactation (41-53 d). Clinical observations, organ weights/histopathology, and haematological/biochemical analyses (in males only) were conducted. No deaths in adult rats were reported.


Signs of developmental toxicity included an increase incidence of pup deaths at 30 and 100 mg/kg bw/d; however, the authors attributed the pup mortality a result of lack of nursing activity in the dams. All surviving offspring at 30 and 100 mg/kg bw/d developed normally during the 4-d lactation observation period.
A LOAEL at 100 mg/kg bw/d and a NOAEL at 30 mg/kg bw/d has been assessed.


As the information has been published by the EPA and is publicly available, the studies have been rated as Klimisch 2.


Ths substance has not been classified according to GHS criteria.