Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline and GLP-Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
5-chloro-α,α,α-trifluoro-2-nitrotoluene
EC Number:
204-280-7
EC Name:
5-chloro-α,α,α-trifluoro-2-nitrotoluene
Cas Number:
118-83-2
Molecular formula:
C7H3ClF3NO2
IUPAC Name:
4-Chloro-1-nitro-2-(trifluoromethyl)benzene

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4

Any other information on results incl. tables

No symptoms of irritation to skin have been observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met