Registration Dossier
Registration Dossier
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EC number: 271-692-1 | CAS number: 68604-41-1 The complex residuum from the distillation of the methyl ester of C16-18 and C18-unsatd. fatty acids. It consists primarily of trialkyl glycerides and undistilled methyl ester of the fatty acids.
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo existing study
- Type of information:
- experimental study
- Remarks:
- based on read-across
- Adequacy of study:
- key study
- Study period:
- From March 1, 1988 to March 15, 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- The main components of the UVCB substance are fatty acids and fatty acid methyl esters. Biodiesel was used to assess the endpoint.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint conclusion:
- no adverse effect observed (not irritating)
- Endpoint conclusion:
- no adverse effect observed (not irritating)
The substance is not skin and eye irritating
The substance is not skin and eye irritating.
There is no structural alerts or physical chemical property that can support a risk for respiratory tract. Due to the low vapour pressure of the substance, the inhalatory route is of minimal relevance
No classification for skin irritation is warranted under 67/548/EEC or Regulation 1272/2008.
No classification for eye irritation is warranted under 67/548/EEC or Regulation 1272/2008.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C16-18 and C18-unsatd., Me esters
- EC Number:
- 267-015-4
- EC Name:
- Fatty acids, C16-18 and C18-unsatd., Me esters
- Cas Number:
- 67762-38-3
- Molecular formula:
- UVCB substance, not univocal molecular formula available
- IUPAC Name:
- UVCB substance, no IUPAC name avalilable Chemical name: C16-C18 and C18 unsaturated alkyl carboxylic acids methyl esters
- Test material form:
- liquid: viscous
- Details on test material:
- - Main characteristic: liquid yellowish
poorly soluble
- Analytical purity: no data
- Lot/batch No.: no data
- registrated with n° 3714/94
Constituent 1
- Specific details on test material used for the study:
- Fatty acids methyl esters (biodiesel)
Test animals / tissue source
- Species:
- rabbit
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye
- Amount / concentration applied:
- single application of 0.1 g
- Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- 1,6,24,48,72 hours after application
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- Approximately 24 hours before the application, the eyes of the rabbits were examined for their state of health. In addition to the visual assessment of the untreated eyes, the rabbits were examined with the aid of a 0.5% aqueous fluorescein sodium solution to determine whether the cornea was intact.
0.1 ml of a 0.5% fluorescein sodium solution was placed in the conjunctival sac of the eyes. 20 seconds later, the so treated eyes were rinsed thoroughly with lukewarm tap water. After that, the examination of the cornea was carried out to determine whether stains had adhered to the cornea. If there is no staining of the cornea, the epithelium is intact.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 6h
- Score:
- ca. 0.75
- Max. score:
- 4
- Reversibility:
- fully reversible within: 18h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not irritating for eyes
- Executive summary:
The substance was tested for primary eye irritation on rabbits by a single application of 0.1 g of the undiluited test product and permanent contact. Reaction on the cornea and iris were not observed. The conjunctival reactions were slight (redness) and disappeared within 24 after the apllication.
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