Registration Dossier
Registration Dossier
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EC number: 942-422-6 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Pre-GLP study following a method equivalent to a recognised guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.42
- Version / remarks:
- To identify ocular irritation potential as defined in 16 CFR 1500.3(4)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Reaction products of ((5E)-5-ethylidenebicyclo[2.2.1]hept-2-ene and (5Z)-5-ethylidenebicyclo[2.2.1]hept-2-ene) and 2-methyl-1,3-butadiene, epoxidized
- EC Number:
- 942-422-6
- Molecular formula:
- Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)
- IUPAC Name:
- Reaction products of ((5E)-5-ethylidenebicyclo[2.2.1]hept-2-ene and (5Z)-5-ethylidenebicyclo[2.2.1]hept-2-ene) and 2-methyl-1,3-butadiene, epoxidized
- Test material form:
- other: liquid
- Details on test material:
- - Physical state: 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: Recognised animal supplier
- Age at study initiation: 8 weeks
- Weight at study initiation: not reported
- Housing: housed 2/cage in suspended wire mesh cages {30" x 18" x 18"}.
- Diet: Rabbit chow ad libitum
- Water: ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%):not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 3 days
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 6 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No.
SCORING SYSTEM: Draize scoring system. Reference 16 CFR 1500.42.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (n=6) rabbits
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (n=6) rabbits
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (n=6) rabbits
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (n=6) rabbits
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (n=6) rabbits
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (n=6) rabbits
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (n=6) rabbits
- Time point:
- 24 h
- Score:
- 0.833
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (n=6) rabbits
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (n=6) rabbits
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (n=6) rabbits
- Time point:
- 24 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (n=6) rabbits
- Time point:
- 48 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (n=6) rabbits
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- No positive corneal scores were noted. No positive iridal scores. No positive conjunctival scores. Very slight irritation (redness and chemosis; max score 1) fully reversed within 72 hours.
- Other effects:
- - Lesions and clinical observations:
None reported.
- Ophthalmoscopic findings: None reported.
- Histopathological findings: None reported.
- Effects of rinsing or washing: Not applicable.
- Other observations: None reported.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- EU criteria not met
- Conclusions:
- Under the conditions of this study the test substance cannot be considered as an eye irritant.
- Executive summary:
The pre-GLP study was completed under 16 CFR 1500.42 following a guideline similar to OECD 405, to assess the irritancy potential of the test material to the eye following a single application in the New Zealand White rabbit. A volume of 0.1 ml of the test material was placed into the conjunctival sac of one eye of 6 animals. The other eye remained untreated and was used for control purposes. Assessment of ocular damage/irritation was made approximately 24, 48 and 72 hours following treatment. No corneal opacity or iridal irritation was observed on any day. Very slight irritation redness and chemosis; max score 1; fully reversed within 72 hours. Based on the applicants recalculation of the mean scores the test material is not considered to be irritating to the eye under Regulation (EC) 1272/2008 criteria due to a complete absence of Corenal Opacity and Corneal Iritis indicative of full reversibility within 21-days. Redness and Chemosis scores were minor and fully reversed within 72 hours. There was additionally an absence of significant variation of responses.
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