Registration Dossier
Registration Dossier
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EC number: 310-083-8 | CAS number: 102242-52-4 The complex residue resulting from the distillation of C6-24 and C6-24 unsatd. fatty acids methyl esters which is derived from natural fats having a carbon range of C6-24. It consists predominantly of satd. and unsatd. fatty acids methyl esters having carbon numbers greater than C20, dimerization products, and wax esters and boils at > 200°C (392°F) at 10 torr.
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo existing study
- Type of information:
- experimental study
- Remarks:
- based on read-across on supporting substance (analogue or surrogate)
- 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:
- other: Well described study conducted to recognized international test guidelines. Non GLP studie
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:
- - Name of test material: Fatty acids C16-C18 and C18 unsaturated methyl esters
- Physical state: light yellow liquid
- Analytical purity: 79.01% (sum of methylesters of C18 fatty acids)
- Certificate of analysis reference EST_P77220_0806159_080814_13
- Water solubility: < 0.13 mg/L (20°C) according to SDS
- Relative density at 20°C: 890 kg/m^3 according to SDS
Constituent 1
- Specific details on test material used for the study:
- fatty acid methyl esters, (biodiesel)
Test animals / tissue source
- Species:
- rabbit
- Details on test animals or tissues and environmental conditions:
- Male adult rabbits of the tribe Little Russian, Chbb: HM, breeder Fa. Thomae, Biberach / D.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye
- Amount / concentration applied:
- single application of 0.1 g undiluted
- 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:
- other: 24h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- ca. 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- 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 appllication.
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