Registration Dossier
Registration Dossier
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EC number: 260-070-5 | CAS number: 56235-92-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 16 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- Study conducted outside the EU over 10 years before the EU cosmetic testing ban came into effect.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.42
- GLP compliance:
- no
Test material
- Reference substance name:
- Bis(2-ethylhexyl) malate
- EC Number:
- 260-070-5
- EC Name:
- Bis(2-ethylhexyl) malate
- Cas Number:
- 56235-92-8
- Molecular formula:
- C20H38O5
- IUPAC Name:
- 1,4-bis(2-ethylhexyl) 2-hydroxybutanedioate
- Test material form:
- liquid
- Details on test material:
- Identification: Dermol DOM
Appearance: Clear colourless to pale yellow liquid
Batch: P7677
Purity/Composition: >95%
Test item storage: At room temperature
Stable under storage conditions until: 31 December 2018 (retest date)
Additional information
Test Facility test item number: 209081/A
Purity/Composition correction factor: No correction factor required
Test item handling: No specific handling conditions required
Molecular structure: Not indicated
Molecular formula: C20H38O5
Molecular weight: 358.5
Constituent 1
- Specific details on test material used for the study:
- Bernel Ester Dom
Lot number 358-203
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 24,48 and 72 after treatment
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0.3
- Irritation parameter:
- iris score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0.3
- Irritation parameter:
- conjunctivae score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0.3
- Irritation parameter:
- chemosis score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0.3
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test article is not an occular irritant to rabbits under the conditions of the test.
- Executive summary:
The test article is not an occular irritant to rabbits under the conditions of the test.
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