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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An appropriate guinea pig maximisation test is available which would not justify conducting an additional LLNA due to animal welfare.

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

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: Vaseline white DAB
Concentration / amount:
25%, 5%, 1% in Vaseline
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Vaseline white DAB
Concentration / amount:
25%, 5%, 1% in Vaseline
No. of animals per dose:
2

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 8.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
72
Group:
test chemical
Dose level:
25%
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 8.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU