Registration Dossier
Registration Dossier
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EC number: 306-084-8 | CAS number: 95912-88-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 Jul - 17 Jul 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions. Few details on the test substance were given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted Feb 1987
- Deviations:
- yes
- Remarks:
- lack of details on test substance
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- lack of details on test substance
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C16-18, isotridecyl esters
- EC Number:
- 306-084-8
- EC Name:
- Fatty acids, C16-18, isotridecyl esters
- Cas Number:
- 95912-88-2
- Molecular formula:
- C29H58O2 and C31H62O2
- IUPAC Name:
- Fatty acids, C16-18, isotridecyl esters
- Details on test material:
- - Name of test material (as cited in study report): isotridecylstearat
- Physical state: colourless liquid
- Date of arrival: 18 May 1987
- 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, Germany
- Weight at study initiation: 2245 g (average)
- Housing: single housing in rabbit cages, (Fa. Henkel, Kuchen, Germany)
- Diet: Altromin feed 2023 (Fa. Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 20-21
- Humidity (%): approximately 45-55
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single application without washing
- Observation period (in vivo):
- 72 h
Reading time points: 1, 6, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 4 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was not washed
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all 4 animals
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all 4 animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of all 4 animals
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all 4 animals
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- 1 hour after instilling the test substance in the eyes, 1/4 rabbits had a slight discharge (grade 1 of 3) and 2/4 severe discharge (grade 3) from the treated eye, while 3/4 rabbits showed slight redness of the eye (grade 1 of 3). At the 6-hour reading time point, 3/4 rabbits showed slight redness and 1/4 still had severe discharge from the eye. These effects cleared completely within 24 hours and none of the animals had eye irritation effects at reading time points 24, 48 and 72 hours.
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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