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Diss Factsheets

Administrative data

Description of key information

1-phentlyethyl acetate was determined to be not irritating to skin and the eye according to studies performed in line with Association of Food and Drug Officials of the United States, Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics (1959).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin 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. With the exception of the contact period, and testing on abraded skin, the guideline used shares the same basic principles as the OECD guideline 404. The use of an occlusive patch, a longer contact time (24 hours instead of 4) and abrading the skin would produce a result bias towards irritation and as such represents a worst case. As no irritation was induced during the study, the results are considered to be a true and accurate reflection of the effects of the test substance.
Qualifier:
according to guideline
Guideline:
other: Association of Food and Drug Officials of the United States, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, 1959, pp 46-48
Deviations:
not specified
GLP compliance:
no
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)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Weight at study initiation: 2-2.5 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
Type of coverage:
occlusive
Preparation of test site:
other: Shaved, abraded and non-abraded sites were used
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST SUBSTANCE- Amount applied: 0.5 mLThe test substance was applied to abraded and non-abraded skin at 4 sites (2 abraded, 2 non-abraded). The abrasions were minor incisions through the stratum corneum, but not sufficient deep to disturb the derma (not to produce bleeding).
Duration of treatment / exposure:
24 hours
Observation period:
Readings were made at 24, 48 and 72 hours after the prescribed exposure period.
Number of animals:
6
Details on study design:
TEST SITE- Area of exposure: 1 inch patch- Type of wrap if used: The patches were secured in place with adhesive tape. The entire trunk of the animal was wrapped with rubberized cloth the entire 24-hour period of exposure. The animals are immobilised in an animal holder.SCORING SYSTEM:Evaluation of the skin reaction for erythema and edema was scored in line with the method followed.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation 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:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within:
Remarks on result:
no indication of irritation
Irritation parameter:
erythema 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:
erythema 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
Irritation parameter:
edema 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:
edema 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:
edema 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:
edema 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:
edema 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:
edema 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 recorded during the course of the study.

Table 2: Readings

  24 hours   48 hours   72 hours    Erythema Edema Erythema Edema Erythema Edema 1 NA 0 0 0 0 0 0 A 0 0 0 0 0 0 A 0 0 0 0 0 0 NA 0 0 0 0 0 0 2 NA 0 0 0 0 0 0 A 0 0 0 0 0 0 A 0 0 0 0 0 0 NA 0 0 0 0 0 0 3 NA 0 0 0 0 0 0 A 0 0 0 0 0 0 A 0 0 0 0 0 0 NA 0 0 0 0 0 0 4 A 0 0 0 0 0 0 NA 0 0 0 0 0 0 NA 0 0 0 0 0 0 A 0 0 0 0 0 0 5 A 0 0 0 0 0 0 NA 0 0 0 0 0 0 NA 0 0 0 0 0 0 A 0 0 0 0 0 0 6 A 0 0 0 0 0 0 NA 0 0 0 0 0 0 NA 0 0 0 0 0 0 A 0 0 0 0 0 0

A = abraded; NA = non-abraded

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the test, the test substance was not considered to be a skin irritant.
Executive summary:

In a pre-GLP skin 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 a skin irritant.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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.
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
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)
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
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
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

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.

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

The key study (Posner, 1971) was performed in line with the Association of Food and Drug Officials of the United States, Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics (1959) pp 46-48, but not to GLP, with a sufficient level of detail to assess the quality of the study. The study was performed to a good standard in line with sound scientific principles and was assigned a reliability score of 2 in accordance with Klimisch (1997).

Eye Irritation

The key study (Posner, 1971) was performed in line with the Association of Food and Drug Officials of the United States, Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics (1959) pp 49-51, but not to GLP, with a sufficient level of detail to assess the quality of the study. The study was performed to a good standard in line with sound scientific principles and was assigned a reliability score of 2 in accordance with Klimisch (1997).


Justification for selection of skin irritation / corrosion endpoint:
Only one study available.

Justification for selection of eye irritation endpoint:
Only one study available.

Justification for classification or non-classification

Skin Irritation

The key study for skin irritation indicates that the test substance has no effect on skin irritation. Therefore the no classification is required in line with Directive 67/548/EEC and Regulation 1272/2008.

Eye Irritation

The key study for eye irritation indicates that the test substance has no effect on eye irritation. Therefore the no classification is required in line with Directive 67/548/EEC and Regulation 1272/2008.