Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
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 also not performed to GLP and the method used is a non-standardised guideline.

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 Food and Drug Officials of the United States, Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics, 1959, pp 54-56
Deviations:
not specified
GLP compliance:
no
Limit test:
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

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Weight at study initiation: 2-2.5 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Rabbits were prepared by clipping the trunk free of hair. Six rabbits were abraded over the entire shaved area with the exception of an area left unabraded. This area served as the control. The remaining rabbits were not abraded. Test substance was applied to each rabbit's back and then each was wrapped in a sleeve to allow the material to remain moist on the treated areas. After twenty-four hours, the rabbits were unwrapped and wiped free of any excess material.
Duration of exposure:
24 hours
Doses:
Approximately 8 mL of test substance
No. of animals per sex per dose:
12 animals (sex not specified)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days- Frequency of observations and weighing: At 24, 48 and 72 h and then daily throughout the 14 days.Evaluation of the skin reaction for erythema and edema was scored in line with the method followed.

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 8 other: mL
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
other: Very slight erythema in two rabbits at 24 hours, which was fully reversible. No behavioural abnormalities or signs of toxicity were observed.
Other findings:
Blood chemistries and urinalysis were within normal ranges.

Any other information on results incl. tables

There was very slight erythema evident in rabbits #4 and #6 at 24 hours. However, during the remainder of the test period, all animals showed no signs of irritation or abnormality. No behavioural changes nor evidence of toxicity were seen within the 14 day test period. Blood chemistries and urinanalysis are within normal ranges and the test substance was considered to be slightly to non-irritating.

Table 1: Readings

   Rabbit no.  Hours        Days                              
     24  48  72  4  5  6  7  8  9  10  11  12  13  14
 Erythema  1  0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Edema    0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Erythema  2  0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Edema    0  0  0  0  0  0  0  0  0  0  0  0  0  0
Erythema  3  0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Edema    0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Erythema  4  0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Edema    0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Erythema  5  0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Edema    0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Erythema  6  0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Edema    0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Erythema  7  0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Edema    0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Erythema  8  0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Edema    0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Erythema  9  0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Edema    0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Erythema  10  0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Edema    0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Erythema  11  0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Edema    0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Erythema  12  0  0  0  0  0  0  0  0  0  0  0  0  0  0
 Edema    0  0  0  0  0  0  0  0  0  0  0  0  0  0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the test, the dermal LD50 of the test substance was determined to be > 8 mL. The LD50 of the test substance was greater than 4 mL/kg bw (approximate).
Executive summary:

In a pre-GLP acute dermal toxicity study conducted 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 54-56, the acute dermal toxicity LD50 of the test substance was determined to be >8 ml (approximately 3.2-4 mL/kg bw) equivalent to 3200 to 4000 mg/kg bw.