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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Considering the structural similarities of both molecules and the probability to act via a common mode of action, it is acceptable to utilise EC 202-429-0 as a read-across source. See attached document for full justification.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Study conducted in 1979 no guideline available.
GLP compliance:
not specified
Remarks:
Study conducted in 1979.
Test type:
other: Oral administration of 50 mg/kg bw o-toluidine to 2 cats per sex

Test material

Constituent 1
Chemical structure
Reference substance name:
o-toluidine
EC Number:
202-429-0
EC Name:
o-toluidine
Cas Number:
95-53-4
Molecular formula:
C7H9N
IUPAC Name:
o-toluidine
Test material form:
liquid

Test animals

Species:
cat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
No specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
1
No. of animals per sex per dose:
2 animals per sex per dose (50 mg/kg only)
Control animals:
not specified
Details on study design:
Oral administration of 50 mg/kg bw o-toluidine to 2 cats per sex, observation over 14 day period.

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
50 mg/kg bw
Based on:
test mat.
Mortality:
1 of 4 cats died during 14 day observation period.
Clinical signs:
ateral position, tachypnea, cyanosis mydriasis, apathy, salivation
Body weight:
not specified
Gross pathology:
not specified
Other findings:
Oral administration of 50 mg/kg bw o-toluidine to 2 cats per sex resulted in 59.6 to 71.7 % methemoglobin within 4 hours after administration.

Applicant's summary and conclusion

Interpretation of results:
Category 2 based on GHS criteria
Conclusions:
Oral administration of 50 mg/kg bw o-toluidine to 2 cats per sex resulted in 59.6 to 71.7 % methemoglobin
within 4 hours after administration, lateral position, tachypnea, cyanosis mydriasis,
apathy, salivation and the death of one cat. During the 14 day-observation period, one cat was in
poor condition and 2 cats recovered (BASF AG, 1979).

Classified as Category 2 for acute oral toxicity
Executive summary:

Oral administration of 50 mg/kg bw o-toluidine to 2 cats per sex resulted in 59.6 to 71.7 % methemoglobin

within 4 hours after administration, lateral position, tachypnea, cyanosis mydriasis,

apathy, salivation and the death of one cat. During the 14 day-observation period, one cat was in

poor condition and 2 cats recovered (BASF AG, 1979).

Classified as Category 2 for acute oral toxicity