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EC number: 239-570-2 | CAS number: 15529-67-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 hours exposure
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- US Study performed 1994 with 6 rabbits.
Well documented, but 25% commercial grade solution used for testing
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 6-rabbits for US
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium zirconium lactate
- EC Number:
- 239-570-2
- EC Name:
- Sodium zirconium lactate
- Cas Number:
- 15529-67-6
- Molecular formula:
- C3H6O3xZr
- IUPAC Name:
- Sodium zirconium lactate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Commercial grade material used at ca 25% solids
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 ml, undiluted as supplied (ie 25% actives)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Up to 72 hours (all animals with no score at this point)
- Number of animals:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1 animal
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: All animals
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant
- Irritation parameter:
- edema score
- Basis:
- animal: All animal
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant
- Irritant / corrosive response data:
- Only one animal showed a slight effect at 1 hour after removal of dressings. This resolved prior to next observation at 24 hours.
No other animals showed any adverse effect.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Although it was uncessary to use 6 animals, the work was performed in accordance with common practice in the US at this period.
Only slight transitory effects were seen in one animal 1 hour after removal of dressings.
The material tested was as supplied as ca 25% actives. The very low irritation of the 25% solution would suggest that the substance need not be classified as irritating to the skin.
The pH of the material was unknown, but current production is for pH 6 - 7.
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