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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
non-LLNA method experimental result was already available
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
1st: Induction .1 % intracutaneous
2nd: Induction 3 % occlusive epicutaneous
3rd: Challenge 1 % occlusive epicutaneous
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
1st: Induction .1 % intracutaneous
2nd: Induction 3 % occlusive epicutaneous
3rd: Challenge 1 % occlusive epicutaneous
No. of animals per dose:
20 animals for test
10 animals for control
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.

RESULTS OF TEST - Sensitization reaction: 0/20 animals positive at 24 hours and at 48 hours = no sensitization no animals positive in control group - Clinical signs: 1st induction, FCA application sites: severe erythema and edema, slight to severe necroses 1st induction, vehicle + test substance application sites: distinct erythema and edema 1st induction, vehicle application sites: slight erythema 2nd induction, test and control groups: some FCA injection sites bleeding, wounds from scratching; crust formation within 24 hours - Other: Mean body weight gain 124.8 g in test group, 120.1 g in control group = expected range

Interpretation of results:
not sensitising
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

According to the available study the substance is not sensitising