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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June to October 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
first version adopted 1981
Deviations:
yes
Remarks:
Exposure period was 8 to 24 hours; dressing type used not specified; testing performed on the ear
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(trifluoromethoxy)aniline
EC Number:
207-317-5
EC Name:
4-(trifluoromethoxy)aniline
Cas Number:
461-82-5
Molecular formula:
C7H6F3NO
IUPAC Name:
4-(trifluoromethoxy)aniline

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, England
- Weight at study initiation: 3-4 kg
- Housing: Individually housed in standard rabbit cages
- Diet: rabbit food provided ad libitum
- Water: provided ad libitum

Test system

Type of coverage:
not specified
Preparation of test site:
other: ear, fur removed
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated skin of each animal served for control
Amount / concentration applied:
0.5 g applied to small cellulose patches
Duration of treatment / exposure:
8 to 24 hours
Observation period:
7 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: ear
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: adhesive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: no

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
other: not applicable
Remarks on result:
other: data not provided
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
other: not applicable
Remarks on result:
other: data not provided
Irritant / corrosive response data:
No skin changes were observed after the dressings were removed or during the post-treatment observation period. Thus, the test item was not a skin irritant under the test conditions used.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
other:
Remarks:
CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008.
Conclusions:
In a study conducted in principle similar to OECD TG 404, the test item was not found to be a skin irritant.