Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given (Peer reviewed source OECD-SIDS)

Data source

Referenceopen allclose all

Reference Type:
other company data
Title:
Unnamed
Year:
1973
Reference Type:
secondary source
Title:
p-Toluidine - CAS No: 106-49-0 - SIDS Initial Assessment Report.
Author:
OECD
Year:
2005
Bibliographic source:
UNEP Publications

Materials and methods

Principles of method if other than guideline:
In an inhalation hazard test, 6 rats were exposed for one hour to vapour concentrations of approximately 0.64 mg p-toluidine/L.
GLP compliance:
no
Remarks:
GLP compliance was not mandatory at the time of the study
Test type:
other: Inhalation hazard test
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
p-toluidine
EC Number:
203-403-1
EC Name:
p-toluidine
Cas Number:
106-49-0
Molecular formula:
C7H9N
IUPAC Name:
4-methylaniline
Details on test material:
- Name of test material (as cited in study report): p-toluidine
- Analytical purity: no data

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 188-260 g



Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
other: not reported
Vehicle:
other: air
Details on inhalation exposure:
The test substance was administered as vapour at room temperature. The total air flow was of 10 litre/min.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
1 h
Concentrations:
0.64 mg/L
No. of animals per sex per dose:
6
Control animals:
other: not applicable
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, gross pathology

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC50
Effect level:
> 0.64 mg/L air
Exp. duration:
1 h
Mortality:
No rat died during and post exposure
Clinical signs:
other: Signs of intoxication started within 0-4 hours and included generalized inactivity, rhinitis and lacrimation, and ceased within one day.
Gross pathology:
Gross autopsy revealed no significant findings

Any other information on results incl. tables

In an inhalation hazard test, 6 rats were exposed for one hour against vapor concentrations of approximately 0.64 mg p-toluidine/L. Signs of intoxication during and post exposure included generalized inactivity, rhinitis and lacrimation, which ceased one day post exposure. No animal died during the exposure or during the 14-day observation period. Gross autopsy revealed no significant findings.

Applicant's summary and conclusion