Registration Dossier
Registration Dossier
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EC number: 203-933-3 | CAS number: 112-07-2
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: Acceptable study with basic documentation which meets basic scientific principles and contains sufficient detail to be able to judge the results reliable as a contribution to the understanding of the toxicity of this substance.
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparative toxicological study of ethyl glycol acetate and butyl glycol acetate
- Author:
- Truhaut R, Dutertre-Catella H, Phu-Lich N, Ngoc Huyen V
- Year:
- 1 979
- Bibliographic source:
- Toxicol Appl Pharmac 51, 117-27
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: see method description below
- Deviations:
- not specified
- Principles of method if other than guideline:
- Method according to (unspecified) French regulations of 1971 which are in turn derived from the method of Draize (1959). The Draize method is the origin of the OECD test method.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-butoxyethyl acetate
- EC Number:
- 203-933-3
- EC Name:
- 2-butoxyethyl acetate
- Cas Number:
- 112-07-2
- Molecular formula:
- C8H16O3
- IUPAC Name:
- 2-butoxyethyl acetate
- Details on test material:
- no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand (unspecified)
- Details on test animals or tissues and environmental conditions:
- no data
Test system
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- no data
- Duration of treatment / exposure:
- no data
- Observation period (in vivo):
- no data
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Only two of the 6 rabbits showed any response which was slight conjunctival redness and discharge in the first 24 hours. From 48hrs onwards there was no adverse effects observable.
- Other effects:
- none reported.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Substance has very low eye irritation potential.
- Executive summary:
In an in vivo eye irritation study in which basic details are available, 2 -butoxyethyl acetate produced only very slight irritation in a few of the exposed rabbits, manifest as mild conjunctival redness, which was fully reversed within 48 hours. The response did not meet the threshold for classification as a eye irritant.
Synopsis
Not irritating.
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