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Toxicological information

Acute Toxicity: oral

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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

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
cat
Strain:
not specified
Sex:
male/female
Details on test animals 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