Registration Dossier
Registration Dossier
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EC number: 954-736-0 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data taken from one or many reviews of high purity higher olefines (C17 - C22, linear and branched)
These oils, whether from mineral or vegetable source, are used in foods, pharmaceutical products and personal care products.
Primary sources are not cited, but references are made to earlier food and paharmaceutal reviews
Report authored by the German MAK Commission
Data source
Reference
- Reference Type:
- publication
- Title:
- White mineral oil, pharmaceutical [review]
- Author:
- A. Hartwig, MAK Commission
- Year:
- 2 017
- Bibliographic source:
- The MAK Collection for Occupational Health and Safety 2017, Vol 2, No 3
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Not specified in the review
- GLP compliance:
- not specified
Test material
- Reference substance name:
- White mineral oil (petroleum)
- EC Number:
- 232-455-8
- EC Name:
- White mineral oil (petroleum)
- Cas Number:
- 8042-47-5
- Molecular formula:
- C15 - C50
- IUPAC Name:
- White mineral oil
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Specified C15 - C15 aliphatic
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- According to guideline, 0.1 ml
- Duration of treatment / exposure:
- Not speified if washed
- Observation period (in vivo):
- At least 72 hours
- Number of animals or in vitro replicates:
- Not specified in the review
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Reversibility:
- other: Not applicabnle
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritant / corrosive response data:
- No indication of further adverse effect in review.
No effect on the cornea reported
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Very low potential for irritation.
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