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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
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:
according to
Guideline:
other: Fed. Reg. 38 No 187,1500.42, 1973
Deviations:
not specified
GLP compliance:
not specified
Remarks:
Study conducted in 1979. Endpoint from collected of data and compliance details are not available.

Test material

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

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
not specified - data from collection of studies

Test system

Vehicle:
not specified
Remarks:
Not specified
Controls:
not specified
Amount / concentration applied:
Not specified - from collection of data
Duration of treatment / exposure:
Not specified - from collection of data - in alignment with Fed. Reg. 38 No 187,1500.42, 1973
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6 animals
Details on study design:
with 6 rabbits, which
was performed according to Fed. Reg. 38 No 187,1500.42, 1973 o-toluidine was judged to be
highly irritating due to slight corneal opacity of the total corneal area, slight to moderate
conjunctival edema and redness and the observed discharge up to the termination of the study on
day 8. Primary irritation score was 31 of max. 110 (BASF AG, 1979).

Results and discussion

In vivo

Results
Irritation parameter:
other: Primary irritation score
Basis:
mean
Time point:
other: Not specified
Score:
31
Max. score:
110
Reversibility:
other: slight to moderate conjunctival edema and redness and the observed discharge up to the termination of the study on day 8
Remarks on result:
other: highly irritating
Irritant / corrosive response data:
o-toluidine was judged to be
highly irritating due to slight corneal opacity of the total corneal area, slight to moderate
conjunctival edema and redness and the observed discharge up to the termination of the study on
day 8. Primary irritation score was 31 of max. 110

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
o-toluidine was judged to be highly irritating due to slight corneal opacity of the total corneal area, slight to moderate
conjunctival edema and redness and the observed discharge up to the termination of the study on
day 8. Classified as Category 2 (irritating to eyes) for eye damage/irritation according to EC 1272/2008.
Executive summary:

o-toluidine was judged to be highly irritating due to slight corneal opacity of the total corneal area, slight to moderate conjunctival edema and redness and the observed discharge up to the termination of the study on

day 8. Primary irritation score was 31 of max. 110

Classified as Category 2 for eye damage/irritation according to EC 1272/2008.