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EC number: 464-300-7 | CAS number: 141645-16-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9th November to 19th November 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted in compliance with: • OECD guideline No. 405, 24th April 2002, • EC Directive No. 2004/73/EEC, B.5, 29th April 2004.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the Study plan.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the Study plan.
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 464-300-7
- EC Name:
- -
- Cas Number:
- 141645-16-1
- Molecular formula:
- C19H17NO5
- IUPAC Name:
- 4-(2-butyl-5-nitro-1-benzofuran-3-carbonyl)phenol
- Details on test material:
- Beige powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Number: three animals were used, as recommended by the international guidelines.
Age/weight: on the day of treatment, the animals were 2 to 4 months old and had a mean body
weight ± standard deviation of 2.8 ± 0.2 kg.
Acclimation: at least 5 days before the beginning of the study.
Identification: individual metal ear tag.
The conditions in the animal room were set as follows:
• temperature: 18 ± 3°C
• relative humidity: 30 to 70%
• light/dark cycle: 12 h/12 h
• ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
The temperature and relative humidity were under continuous control and recording. The records were checked daily and filed. In addition to these
daily checks, the housing conditions and corresponding instrumentation and equipment were verified and calibrated at regular
intervals.
The animals were housed individually in Techniplast cages (64 cmx 63 cm x 30 cm).
Each cage was equipped with a food container and a water bottle.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 100mg
- Duration of treatment / exposure:
- The eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the test item.
The study was ended on day 4 in the absence of persistent ocular reactions. - Observation period (in vivo):
- The eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the test item.
The study was ended on day 4 in the absence of persistent ocular reactions. - Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
Any other information on results incl. tables
Very slight to moderate conjunctival reactions including a very slight or a slight chemosis (grade 1 or 2), a slight or a moderate redness of the conjunctiva (grade 1 or 2) and a clear discharge, were observed in all animals from day 1; some of these reactions persisted up to day 2 (1 animal) or 3 (2 animals). No other ocular reactions were observed during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions, the test item is slightly irritant when administered by ocular route to rabbits. However according to the
classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations) on the approximation of the laws, regulations and
administrative provisions relating to the classification, packaging and labeling of dangerous substances, the test item should not be classified as
irritating to the eyes. - Executive summary:
Under the experimental conditions, the test item is slightly irritant when administered by ocular route to rabbits. However according to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations) on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances, the test item should not be classified as irritating to the eyes
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