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EC number: 205-587-9 | CAS number: 143-15-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-bromododecane
- EC Number:
- 205-587-9
- EC Name:
- 1-bromododecane
- Cas Number:
- 143-15-7
- Molecular formula:
- C12H25Br
- IUPAC Name:
- 1-bromododecane
- Test material form:
- other: Liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- The temp. and relative humidity were set to achieve limits of 17 to 23 deg. C and 30 to 70% respectively. The rate of air exchange was at least 15 changes per hour and lighting was controlled.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left untreated eye was used for control
- Amount / concentration applied:
- A volume of 0.1m of the test material was placed into the conjunctival sac of the right eye.
- Duration of treatment / exposure:
- 1 hr, 24 hr, 48hr, 72hr
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made appr. 1 hour and 24, 48 and 72 hours following treatment.
- Number of animals or in vitro replicates:
- Initially a single rabbit was treated. After consideration of the ocular responses, two additional animlas were treated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1hr, 24hr, 48 hr, 72hr
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1hr, 24hr, 48 hr, 72hr
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1hr, 24hr, 48 hr, 72hr
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1hr, 24hr, 48 hr, 72hr
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Irritant / corrosive response data:
- No conrneal or iridial effects were noted during hte study.
Minimal conjunctival irritation was noted in all treated eyes one hour after treatment.
All treated eye 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: OECD GHS
- Conclusions:
- A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjuctival irritation. All treated eyes appeared normal at the 24-hour observation
- Executive summary:
Introduction: The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbity. The method was designed to meet the requirenmnets of the following:
• OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye IrritationlCorrosion” (adopted 24 February 1987)
• Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation)
Result. A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. All treated eyes appeared normal at the 24-hour observation.
• OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye IrritationlCorrosion” (adopted 24 February 1987)
• Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation)
Result. A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. All treated eyes appeared normal at the 24-hour observation.
Conclusion. The test material produced a maximum group mean score of 6.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 93/21/EEC.
The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 93/21/EEC.
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