Registration Dossier
Registration Dossier
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EC number: 616-328-8 | CAS number: 76359-37-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Analogue substance tested.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
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:
- Analogue substance (refer to IUCLID chapter 13)
- IUPAC Name:
- Analogue substance (refer to IUCLID chapter 13)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- The application volume was 0.1 g per animal. The test article was applied undiluted.
- Duration of treatment / exposure:
- A single dose was administered to the left eye of each animal. The right eye remained untreated and was used as the reference control.
- Observation period (in vivo):
- The eyes of each animal were examined 1-, 24-, 48- and 72 hours after administration.
- Number of animals or in vitro replicates:
- 2 males, 1 female
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 1 - 1.7
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No corrosion was observed at each of the measuring intervals.
- Other effects:
- In the area of application a blue discoloration of the cornea and conjunctivae was observed which could be related to effects of the test article.
Applicant's summary and conclusion
- Conclusions:
- The study on the primary eye irritation study was carried out with the analogue substance. As a result of the study, a slight conjunctival redness was still existing in one animal after 72 hours. Based on the short observation period (which was not prolonged up to 21 days as recommended) the full reversibility of the effect could not be demonstrated. Due to the structural similarity of the analogue substance and the substance subject of registration, the substance subject of registration is expected to show a comparable behaviour. According to the actual guidelines, the substance subject of registration has to be classified according to CLP regulation as category 1 ("irreversible effects on the eye").
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