Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation / corrosion, 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:
See attached justification for supporting informaiton.

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:
Undiluted o-toluidine was applied to the intact and to the scarified skin of the flank of rabbits under occlusive conditions. Following the 24-hour treatment time the treated area was washed with water.
Study conducted in 1979 - no guideline available.
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

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Remarks:
both intact skin and abraded skin had o-toluidine applied
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Applied Undiluted, No volume stated.
Duration of treatment / exposure:
24 hour treatment
Observation period:
72 hour observation
Number of animals:
6 animals (intact skin) and in 6 animals (scarified skin)
Details on study design:
undiluted o-toluidine was applied to the intact and to the scarified skin of the flank of rabbits under occlusive conditions. Following the 24-hour treatment time the treated area was washed with water.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Time point:
other: up to 8 days
Reversibility:
not specified
Remarks on result:
other: moderately irritating
Irritant / corrosive response data:
Slight to moderate erythema and moderate edema of the intact skin were observed for 72 hours. At 72 hours
these animals exhibited scaling, which was still observed on day 8. Necrosis was observed in 1/6
animals (intact skin) and in 6/6 animals (scarified skin) until termination of the study. Overall, the
authors evaluated o-toluidine as moderately irritating.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
O-toluidine was assed as being moderately irritating. It is therefore not classified for skin irritation.
Executive summary:

Slight to moderate erythema and moderate edema of the intact skin were observed for 72 hours. At 72 hours

these animals exhibited scaling, which was still observed on day 8. Necrosis was observed in 1/6

animals (intact skin) and in 6/6 animals (scarified skin) until termination of the study. Overall, the

authors evaluated o-toluidine as moderately irritating.

Not classified for skin irritation.