Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
1971
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

Constituent 1
Chemical structure
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
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.