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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

No reliable data are available for the test substance. The toxicological assessment is based on read-across to CAS 10039-54-0.


 


Skin sensitization:


sensitizing (GPMT according to OECD 406, GLP not specified, reliability 2)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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.
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
Justification for non-LLNA method:
Study was performed prior to existence of LLNA guideline.
Species:
guinea pig
Strain:
Hartley
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Acclimation period: 14 days
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
- intradermal injection: 5%; - topical induction: 25%
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
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
Group:
test chemical
No. with + reactions:
15
Total no. in group:
15
Remarks on result:
positive indication of skin sensitisation

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).

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
Based on the study findings the test item causes skin sensitization Cat. 1 based on GHS criteria.
Executive summary:

The available study performed according to OECD TG 406 was a comparative study designed to validate the mouse ear swelling test in comparison to common patch testing (or Buehler) and maximisation test. 100% of the treated guinea pigs showed a positive reaction leading to a classification as skin sensitizer Cat. 1.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

No reliable data for the test substance do exist. The toxicological assessment is based on the available data of CAS 10039-54-0.


The available study performed according to OECD TG 406 (GLP not specified, reliability 2) was a comparative study designed to validate the mouse ear swelling test in comparison to common patch testing (or Buehler) and maximisation test. 100% of the treated guinea pigs showed a positive reaction leading to a classification as skin sensitizer Cat. 1.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008


The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008.


The experimental data justify a classification as skin sensitizer Cat. 1 under Regulation (EC) No. 1272/2008, as amended for the seventeenth time in Regulation (EC) No. 2021/849.