Registration Dossier
Registration Dossier
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EC number: 240-032-4 | CAS number: 15894-70-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Test material form:
- solid: crystalline
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Conventional Animal Breeding Unit
- Age at study initiation: Young adults
- Weight at study initiation: 3649-3939g
- Housing: aluminium sheet cages (65.2 x 68.9 x 45.7 cm)
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-19°C
- Humidity (%): 30-70
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Approximately 100mg per eye
- Duration of treatment / exposure:
- Not applicable
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE:
Test substance was not removed
SCORING SYSTEM:
Draize 1959, Appendix C
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritant / corrosive response data:
- There were no corneal or iridial effects. Conjunctival effects were only observed approximately 1 hour after application and consisted of slight redness in all 3 animals, slight chemosis in 1 animal, a slight discharge in 1 animal and severe discharge in 1 animal. Additional observations were confined to slight erythema on the upper and/or lower eyelid of 2 animals approximately 1 hour after application and a dried secretion on the periorbital skin of 2 animals 1 day after application. All signs of irritation had completely recovered by 24 hours.
- Other effects:
- Application into the eye caused a slight to moderate initial pain reaction (class 2-3 on a scale of 0-5).
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- HMBDA was a slight irritant to the rabbit eye
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