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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented Study according to guideline and under GLP-conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test

Test material

Constituent 1
Chemical structure
Reference substance name:
3-chloro-o-toluidine
EC Number:
201-756-6
EC Name:
3-chloro-o-toluidine
Cas Number:
87-60-5
Molecular formula:
C7H8ClN
IUPAC Name:
3-chloro-2-methylaniline

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright-Wight Hoe-Strain DHPK (SPFLac)
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Remarks:
for induction and first challenge, petrolatum in second challenge
Concentration / amount:
Cannot be standardized for the Buehler test. Established in preliminary tests.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Remarks:
for induction and first challenge, petrolatum in second challenge
Concentration / amount:
Cannot be standardized for the Buehler test. Established in preliminary tests.
No. of animals per dose:
20
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
6
Total no. in group:
20
Clinical observations:
Erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: Erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
Erythema, dry-rough skin, fine scales
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: Erythema, dry-rough skin, fine scales.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: not specified