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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

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: Acceptable, well documented publication (with a short method description) which meets basic scientific principles.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Development and Validation of an Alternative Dermal Sensitization Test: The Mouse Ear Swelling Test (MEST)
Author:
Gad, S.C., Dunn, B.J., Dobbs, D.W., Reilly, C., Walsh, R.D.
Year:
1986
Bibliographic source:
Toxicology and Applied Pharmacology, 84, 93-114
Reference Type:
publication
Title:
A Scheme for the Prediction and Ranking of Relative Potencies of Dermal Sensitizers Based on Data from Several Systems.
Author:
Gad, S.C.
Year:
1988
Bibliographic source:
Journal of Applied Toxicology, 8(5), 361-368

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not applicable
Remarks:
(due to missing details in the method description)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
- Name of test material (as cited in study report): hydroxylamine sulfate

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Acclimation period: 14 days

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
- intradermal injection: 5%; - topical induction: 25%; - challenge: 10%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
- intradermal injection: 5%; - topical induction: 25%; - challenge: 10%
No. of animals per dose:
15 (test group), 6 (control group)
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: 48 h
- Site: intradermal injected skin site


B. CHALLENGE EXPOSURE
- Exposure period: 24 h
- Site: naive skin site



Results and discussion

Any other information on results incl. tables

100% of the treated guinea pigs showed a positive reaction. Based on a self-made ranking and classification system (Gad,1988), hydroxylamine sulfate has to be classified in class III (moderate sensitizer).

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information