Registration Dossier
Registration Dossier
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EC number: 214-804-6 | CAS number: 1195-79-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- other:
- Title:
- Butyl Acetates (Cicads 64, 2005)
- Author:
- International Programme on Chemical Safety (IPCS)
- Year:
- 2 005
- Bibliographic source:
- Butyl Acetates (Cicads 64, 2005);Concise International Chemical Assessment Document 64; World Health Organization; Geneva, 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- An ocular irritation study was conducted on New Zealand White rabbits to assess the adverse effects caused by the chemical tert-butyl acetate (CAS No: 540-88-5).
- GLP compliance:
- not specified
Test material
- Reference substance name:
- tert-butyl acetate
- EC Number:
- 208-760-7
- EC Name:
- tert-butyl acetate
- Cas Number:
- 540-88-5
- Molecular formula:
- C6H12O2
- IUPAC Name:
- tert-butyl acetate
- Test material form:
- liquid
- Details on test material:
- Name of the test chemical: tert-butylacetate
Molecular Formula: C6H12O2
Molecular Weight: 116.16 g/mol
Physical State: Liquid
Constituent 1
- Specific details on test material used for the study:
- Name of the test chemical: tert-butylacetate
Molecular Formula: C6H12O2
Molecular Weight: 116.16 g/mol
Physical State: Liquid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- No data available
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 1, 24, 48, 72, and 96 h and 7 days
- Number of animals or in vitro replicates:
- 5
- Details on study design:
- - Area of exposure: conjunctival sac
-SCORING SYSTEM: Draize method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 4.8
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 96 hours
- Remarks on result:
- other: Minimal conjunctival irritation was observed,
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3.6
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 96 hours
- Remarks on result:
- other: Minimal conjunctival irritation was observed,
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- other: 96 hours
- Remarks on result:
- other: Minimal conjunctival irritation was observed,
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 96 hours
- Score:
- 1.6
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Minimal conjunctival irritation was observed, which lasted for 96 h.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Conclusions:
- The chemical caused minimal conjunctival irritation, which lasted for 96 h and the mean Draize scores were 4.8, 3.6, 2.0, 2.0, 1.6, and 0 at observation times of 1, 24, 48, 72, and 96 h and 7 days, respectively. Hence the chemical tert-butyl acetate (CAS No: 540-88-5) was considered as not irritating to the eyes.
- Executive summary:
An ocular irritation study was conducted on New Zealand White rabbits to assess the adverse effects caused by the chemical tert-butyl acetate (CAS No: 540-88-5).
Approximately, 0.1ml of test chemical was place into the conjunctival sac of each rabbit which caused minimal conjunctival irritation, which lasted for 96 hours.
The mean Draize scores were 4.8, 3.6, 2.0, 2.0, 1.6, and 0 at observation times of 1, 24, 48, 72, and 96 h and 7 days, respectively.
Since the observed effects were not persisted, the chemicaltert-butyl acetate (CAS No: 540-88-5)was considered as not irritating to the eyes.
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