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EC number: 266-417-7 | CAS number: 66587-56-2
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD guideline, and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Alcohols, C6-12
- EC Number:
- 271-642-9
- EC Name:
- Alcohols, C6-12
- Cas Number:
- 68603-15-6
- IUPAC Name:
- octan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Tradename Linevol 79, C6-12 alcohols Type C
- Physical state: clear, colourless liquid
- Storage condition of test material: cool conditions (not exceeding 15C), protected from light in the original container
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield SPF Rabbits, Hampshire, UK
- Age at study initiation: 5 months
- Weight at study initiation: 2.7 - 2.97 kg
- Housing: individually housed in suspended stainless steel cages mounted in mobile batteries.
- Diet: standard pelleted rabbit diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: yes, but unspecified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-23
- Humidity (%): 40-70
- Air changes (per hr): min. 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 18.10.1995 To: 11.12.1995
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated eye.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- single instillation, unwashed
- Observation period (in vivo):
- The behaviour of each rabbit was observed for several minutes immediately following instillation of the test material to allow assessment of the initial pain response. Ocular reaction to treatrment were assessed 1, 24, 48 and 72 hours after treatment. Additional observations of persistent ocular lesions or irritation responses were made on days 8, 15, 22 and 29 (last day of observation period).
- Number of animals or in vitro replicates:
- 3F
- Details on study design:
- SCORING SYSTEM: According to OECD guideline
TOOL USED TO ASSESS SCORE: ophthalmoscope or pencil beam torch. From 24 hours as required one drop fluorescein used to assess corneal injury.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 29 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 29 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 29 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 1.1
- Max. score:
- 1.3
- Reversibility:
- fully reversible within: 29 days
- Irritant / corrosive response data:
- AVERAGE SCORE (24+48+72 hours)
- Cornea: individual scores all 2 (group mean score 2)
- Iris: individual scores all 1 (group mean score 1)
- Conjuntivae (Redness): individual scores all 2 (group mean scores 2)
- Conjunctivae (Chemosis): individual scores 1.3, 1.3, 0.7 (group mean score 1.1)
REVERSIBILITY: After 7 days conjunctivial injection was apparent in all animals (grade 1 some vessels definitely injected) persisting in two animals until day 22. By day 29 all eyes were overtly normal. - Other effects:
- Crimson-red conjunctival appearance, very slight/slight chemosis and discharge, iritis and slight corneal opacity covering up to the entire corneal surface were observed during the first 72 hours post instillation. Corneal stippling observed in one animal at 48 hours. Very slight initial pain response.
Applicant's summary and conclusion
- Interpretation of results:
- Category II
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Linevol 79 is an eye irritant according to EU criteria based on a mean 24+48+72 hour score for iritis of 1 in all test animals. Based on scores for conjunctivitis and corneal opacity of 2 and iritis of 1 and eventual reversibility of the response by 29 days (effects at 22 days were minimal) Linevol 79 is considered a category 2 eye irritant under CLP.
Classification: irritating
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