Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 236-691-2 | CAS number: 13465-08-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- No data.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted prior to the establishment of standardised guidelines.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- For the initial induction, guinea pigs were administered hydroxylammonium sulphate (5%, in water) via intradermal injection. At day 7, animals were administered a topical induction of 25% of the test substance in water followed by a challenge treatment of 10% of the test substance in water at dat 21. At day 55, rechallenge was conducted.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Hydroxylamine sulphate
- IUPAC Name:
- Hydroxylamine sulphate
- Details on test material:
- Purity > 98%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Induction
Intradermal injection: 5% concentration of hydroxylammonium sulphate in water
Topical induction: 25% of hydroxylamonium sulphate in water
Challenge
10% hydroxylammonium sulphate
Challengeopen allclose all
- Route:
- other: Epicutaneous (occlusivity not stated)
- Vehicle:
- water
- Concentration / amount:
- Induction
Intradermal injection: 5% concentration of hydroxylammonium sulphate in water
Topical induction: 25% of hydroxylamonium sulphate in water
Challenge
10% hydroxylammonium sulphate
- No. of animals per dose:
- 24 animals
- Details on study design:
- For the initial induction, guinea pigs were administered hydroxylammonium sulphate (5%, in water) via intradermal injection. At day 7, animals were administered a topical induction of 25% of the test substance in water followed by a challenge treatment of 10% of the test substance in water at dat 21. At day 55, rechallenge was conducted.
- Challenge controls:
- Control animals were administered only vehicle during the intradermal and topical induction. At the challenge, 10% of the test substance in water was administered.
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 22
- Total no. in group:
- 24
- Clinical observations:
- moderate to intense redness and swelling
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 10%. No with. + reactions: 22.0. Total no. in groups: 24.0. Clinical observations: moderate to intense redness and swelling.
- Reading:
- 2nd reading
- Hours after challenge:
- 55
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 22
- Total no. in group:
- 24
- Clinical observations:
- moderate to intense redness and swelling
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 55.0. Group: test group. Dose level: 10%. No with. + reactions: 22.0. Total no. in groups: 24.0. Clinical observations: moderate to intense redness and swelling.
- Reading:
- 1st reading
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 24
- Clinical observations:
- No dermal reactions were observed
- Remarks on result:
- other: Reading: 1st reading. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 24.0. Clinical observations: No dermal reactions were observed.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Bis(hydroxylammonium)sulphate was shown to cause sensitisation reactions in guinea pigs.
- Executive summary:
In Magnusson Kligman Test, similar to OECD Guideline 406, bis(hydroxylammonium)sulphate was administered to guinea pigs via intradermal injection on day 1 and topical application on day 7 as part of the induction period. Animals were challenged with the chemical on days 21 and 55 which caused sensitisation in 96% of the animals. Dermal reactions were classified into grade 2/3 (moderate to intense redness and swelling). By this study design in guinea pigs bis(hyroxylammonium)sulphate is considered to be a sensitising agent. This study is considered to be reliable with restrictions as the study was conducted prior to the establishment of standardised guidelines.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
