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Registration Dossier
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EC number: 202-288-5 | CAS number: 93-92-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not stated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in accordance with generally accepted scientific principles, but incomplete reporting on results and discussion, which do not affect the quality of the relevant results. Study was not performed to GLP. The guideline to which the study was performed is basically comparable to the OECD guideline 405.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Association of the Food and Drug Officials of the United States: Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics, Baltimore, Maryland, 1959 pp 49-51
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- 1-phenylethyl acetate
- EC Number:
- 202-288-5
- EC Name:
- 1-phenylethyl acetate
- Cas Number:
- 93-92-5
- Molecular formula:
- C10H12O2
- IUPAC Name:
- 1-phenylethyl acetate
Constituent 1
- Specific details on test material used for the study:
- - Name of test material : 1-phenylethyl acetate
- Name of test material (as cited in study report): USA2850 Methyl Phenyl Carbinyl Acetate (styrallyl acetate)
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Weight at study initiation: 2.0-2.5 kg- Housing: in accordance with standard laboratory procedure- Diet (e.g. ad libitum): in accordance with standard laboratory procedure- Water (e.g. ad libitum): ad libitum
Test system
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- TEST SUBSTANCE- Amount applied: 0.1 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Three rabbits were used in the 'no wash group' and three rabbits were used in the 'four-second wash group'.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE- Washing: The eyes of three rabbits were washed with 20 mL of lukewarm water four seconds post installation.- Time after start of exposure:SCORING SYSTEM: Please refer to field "Any other information on material and methods incl. tables" under the heading "Table 1: Scale of scoring ocular lesions"TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 20
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 20
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 20
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 20
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 20
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation noted in any of the animals during the course of the study.
- Other effects:
- Sting reaction noted upon application
Any other information on results incl. tables
Table 2: Eye irritation scores
Rabbit No. Hours Cornea A x B x 5 =IrisA x 5 = Conjunctivae (A + B + C) x 2 = Total score* No wash 1 24 0 0 0 0 0 0 0 48 0 0 0 0 0 0 0 72 0 0 0 0 0 0 0 2 24 0 0 0 0 0 0 0 48 0 0 0 0 0 0 0 72 0 0 0 0 0 0 0 3 24 0 0 0 0 0 0 0 48 0 0 0 0 0 0 0 72 0 0 0 0 0 0 0 Four-second wash 4 24 0 0 0 0 0 0 0 48 0 0 0 0 0 0 0 72 0 0 0 0 0 0 0 5 24 0 0 0 0 0 0 0 48 0 0 0 0 0 0 0 72 0 0 0 0 0 0 0 6 24 0 0 0 0 0 0 0 48 0 0 0 0 0 0 0 72 0 0 0 0 0 0 0
*Total score possible/animal/observation interval = 110
Note: sting reaction when applied to eye.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the test, the test substance was not considered to be an eye irritant.
- Executive summary:
In a pre-GLP eye irritation study conducted in line with the Association of the Food and Drug Officials of the United States: Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics, 1959 pp 49-51, the test substance was determined not to be an eye irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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