Registration Dossier
Registration Dossier
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EC number: 287-828-8 | CAS number: 85586-25-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 11 Mar - 18 Mar 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study with acceptable restrictions; analytical purity of test item was not given.
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:
- yes
- Remarks:
- lack of details on test substance
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C14-18 and C16-18-unsatd., Me esters
- EC Number:
- 267-007-0
- EC Name:
- Fatty acids, C14-18 and C16-18-unsatd., Me esters
- Cas Number:
- 67762-26-9
- Molecular formula:
- UVCB substance, not univocal molecular formula available
- IUPAC Name:
- Fatty acids, C14-18 and C16-18 unsaturated, methyl esters
- Details on test material:
- - Name of test material (as cited in study report): Fettsäuremethylester (C14-18 und C16-18)
- Physical state: yellow, clear liquid
- Analytical purity: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kleinrusse Chbb: HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Fa. Thomae, Biberach, D
- Weight at study initiation: 2540 g
- Housing: individually
- Diet: Altromin-Haltungsdiät 2023, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 72 hours
Reading time points: 1, 6, 24, 48 and 72 hours after application - Number of animals or in vitro replicates:
- 4
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: the treated eye was not rinsed
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: no effect in any animal
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: no effect in any animal
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: slight redness graded 1 was observed in 3/4 animals at reading time point 1 hour and in 2/4 animals at reading time point 6 hour; the finding disappeared within 24 hours.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: no effect in any animal
- Irritant / corrosive response data:
- Reactions on cornea and iris were not observed. Slight conjunctival redness was seen after 1 and 6 hours following application, but disappeared within 24 hours after application.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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