Registration Dossier
Registration Dossier
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EC number: 942-924-5 | CAS number: -
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:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report equivalent or similar to OECD guideline 405: GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- 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:
- Hydrocarbons, C9-C11, cyclics, < 2% aromatics
- IUPAC Name:
- Hydrocarbons, C9-C11, cyclics, < 2% aromatics
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG
- Age at study initiation: ca. 14-15 weeks
- Weight at study initiation: 2.9-2.5 kg
- Housing: individually
- Diet (e.g. ad libitum): Pelleted standard Kliba 341, batch 34/88 rabbit maintenance diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days under laboratory conditions after veterinary examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of each animal (the right eye) served as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml - Duration of treatment / exposure:
- The test material was instilled into the lower conjunctival sac of the left eye of each animal. The upper and lower lids were gently held together for approximately 1 second to prevent loss of the material. The right eye remained untreated and served as the reference control.
- Observation period (in vivo):
- The eyes of each animal were examined 1, 24, 48, and 72 hours after administration. The irritation was assessed according to the OECD guidelines for testing of chemicals, section 4, number 405 "Acute eye irritation/corrosion" adopted February 24, 1987.
- Number of animals or in vitro replicates:
- 3 males, 3 females
- Details on study design:
- SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The mean corneal opacity, iris lesion, conjunctivae redness, and chemosis scores for MRD-91-972 were all 0. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
C9-C11, cyclic aliphatics was administered to the left eye of three male and three female rabbits to assess for ocular irritation. Ocular examinations occurred at 1h, 24h, 48h, 72h. Ocular damage was assessed and scored according to the Draize eye test. All animals survived the exposure. The mean corneal opacity, iris lesion, conjunctivae redness, and chemosis scores for C9-C11, cyclic aliphatics were 0, 0, 0, and 0 respectively. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations.
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