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EC number: 931-467-7 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1997-11-17 to 1997-11-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as "reliable without restriction" because it was carried out according to Guidelines (EPA 798.4500, OECD 405, 92/69/EEC B.5 and MAFF 59 NohSan No. 4200) and was GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
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:
- Alkenes, C20-24
- IUPAC Name:
- Alkenes, C20-24
- Details on test material:
- - Name of test material (as cited in study report): C20-C24 alkenes, branched and linear
- Substance type: Alkenes, C20-24
- Physical state: Straw coloured liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 to 16 weeks old
- Weight at study initiation: 2.48 to 2.93 Kg
- Housing: Individually housed in suspended metal cages
- Diet (e.g. ad libitum): STANRAB SQC Rabbit Diet; ad libitum
- Water (e.g. ad libitum): Mains drinking water; ad Libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 20
- Humidity (%): 50 to 65%
- Air changes (per hr): 15 changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Single treatment; 72 hours
- Observation period (in vivo):
- 1, 24, 48, and 72 hours
- Number of animals or in vitro replicates:
- 9
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, in a group of 3 rabbits
- Time after start of exposure: 30 seconds
SCORING SYSTEM: Draize method of "Eye toxicity tests" (Draize, J.H.; 1977)
TOOL USED TO ASSESS SCORE: Light source from a standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- ca. 0
- Max. score:
- 110
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Results for Group 1
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- ca. 0
- Max. score:
- 110
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Results for Group 2
- Irritant / corrosive response data:
- In Group 1, conjunctival redness was noted in three treated animals at 1 hour of observation, while in Group 2, conjunctival redness was noted in two treated eyes at 1 hour of observation.
Any other information on results incl. tables
No corneal or iridial effects were noted during the study in either Group 1 or Group 2.Conjunctival redness was noted in three treated eyes and two treated eyes in Group 1 and Group 2 animals respectively, at the 1-hour observation. All treated eyes appeared normal at the 24-hour observation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material , C20-C24 ALKENES, BRANCHED AND LINEAR is not irritating when instilled in rabbit eyes.
- Executive summary:
In an acute eye irritation test, C20-C24 alkenes, branched and linear, was instilled into rabbit eyes with a single 0.1 mL volume in the conjunctival sac of the right eye. Irritation was assessed in both unwashed and washed eyes. Results were reported according to the numerical scoring system based on Draize (1977); irritation scores were weighted and averaged to calculate a Draize score. For both unwashed and washed rabbit eyes, conjunctival redness was observed at the 1 hour observation period. All treated eyes appeared normal at the 24-hour observation. This resulted in a Draize score of 0.0 and the test material was classified as not irritating to rabbit eyes.
This study received a Klimisch score of 2 and was classified as "reliable without restriction" because it was carried out according to Guidelines (EPA 798.4500, OECD 405, 92/69/EEC B.5 and MAFF 59 NohSan No. 4200) and was GLP compliant.
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