Registration Dossier
Registration Dossier
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EC number: 406-040-9 | CAS number: 125643-61-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not specified
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted to GLP (taken from SNIF file). Registrant referring to studies >12 years old at the permission of ECHA. This is the first of two studies conducted for this endpoint; justification for the second study is not provided within the information provided.
Data source
Reference
- Reference Type:
- other: body responsible for the test.
- Title:
- Unnamed
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 84/449/EWG, B.5; OECD 405 (1981)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 406-040-9
- EC Name:
- -
- Cas Number:
- 125643-61-0
- Molecular formula:
- C17 H25 O3 R, Where R = (C7 H15) or (C8 H17) or (C9 H19)
- IUPAC Name:
- C7-9-(branched)-alkyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand White (KFM-NZW)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- Not specified. Presumably in accordance with the guideline.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: overall at 24,48 and 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 1 day
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: overall at 24,48 and 72 h
- Score:
- 0.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: overall at 24,48 and 72 h
- Score:
- 0.6
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: overall at 24,48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: overall at 24,48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: overall at 24,48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: overall at 24,48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: overall at 24,48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: overall at 24,48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: overall at 24,48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: overall at 24,48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: overall at 24,48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Test animals showed minor effects related to conjunctival irritation. Changes were fully reversible within 3 days
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Test animals showed minor effects related to conjunctival irritation. Changes were fully reversible within 3 days
- Executive summary:
Test animals showed minor effects related to conjunctival irritation. Changes were fully reversible within 3 days.
No classification is applicable.
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