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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Insufficient details about the study design and results reported. Only one animal was used for testing purposes.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Hydroxylammonium sulphate
- IUPAC Name:
- Hydroxylammonium sulphate
- Test material form:
- not specified
- Details on test material:
- No data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No data.
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 0.1ml of hydroxylammonium sulphate.
- Duration of treatment / exposure:
- No data.
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- No data.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No effect
- Irritant / corrosive response data:
- Conjunctival redness of 3, conjunctival edema mean score of 1.3. Mean scores was determined from appearance at 24, 48 and 72 hours). Iritis (grade 1) was detected on day 1 only, no corneal response was observed. No conjunctival irritation was observed after 8 days.
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Hydroxylammonium sulphate (0.1ml) is considered to be cause moderate eye irritation in rabbits resulting in conjunctival redness, conjunctival edema and iritis. Effects were resolved after 8 days.
- Executive summary:
In a Draize eye irritation study, hydroxlammonium sulphate caused moderate eye irritation in rabbits after a single dose of 0.1 ml. Conjunctival redness, conjunctival edema and iritis were observed but had completly resolved after 8 days.
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.
