Registration Dossier
Registration Dossier
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EC number: 231-832-4 | CAS number: 7758-09-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- data is from safety assessment reports
Data source
Reference
- Reference Type:
- other: Secondary Literature
- Title:
- OECD SIDS Initial Assesment Report
- Author:
- OECD SIDS
- Year:
- 2 005
- Bibliographic source:
- OECD SIDS report
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To assess the dermal irritation potential of the test chemical in rabbits
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium nitrite
- EC Number:
- 231-555-9
- EC Name:
- Sodium nitrite
- Cas Number:
- 7632-00-0
- Molecular formula:
- HNO2.Na
- IUPAC Name:
- Sodium nitrite
- Test material form:
- solid
- Details on test material:
- Name: Sodium nitrite
InChI: 1S/HNO2.Na/c2-1-3;/h(H,2,3);/q;+1/p-1
Smiles : N(=O)[O-].[Na+]
Molecular formula :NNaO2
Molecular weight :68.995 g/mole
Substance type:Inorganic
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Sex: male
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 500mg
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- one hour, one, two and three days after removal of the chemical
- Number of animals:
- 6 male rabbits
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hour
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Some slight irritation was observed one hour after removal of the substance, but all signs had disappeared by the one day observation
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Conclusions:
- Some slight irritation was observed one hour after removal of the test chemical, but all signs had disappeared by the one day observation. Hence, the test chemical can be considered to be not irritating to skin.
- Executive summary:
A dermal irritation study was performed to assess the dermal irritation potential of the test chemical in rabbits. Approximately 500 mg of the test chemical was applied to the shaved backs of 6 male New Zealand White rabbits and covered with a semi-occlusive dressing for four hours. The animals were examined one hour, one, two and three days after removal of the chemical. Some slight irritation was observed one hour after removal of the test chemical, but all signs had disappeared by the one day observation. Hence, the test chemical can be considered to be not irritating to skin.
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