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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Acceptable, study containing basic data which suggests that basic scientific principles have been met. This is sufficient to judge the results reliable as a contribution to the understanding of the toxicity of this substance. A number of observations missing but not considered critical bearing in mind the very low toxicity observed.

Data source

Reference
Reference Type:
publication
Title:
Range finding toxicity data: List VI
Author:
Smyth HF, Carpenter CP, Weil CS, Pozzani UC, Striegel BS
Year:
1962
Bibliographic source:
Am Ind Hyg Ass J, 23, 95

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Similar to one day cuff method of Draize (J Pharmac Exp Therap, 82, 377, 1944)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl acetate
EC Number:
205-500-4
EC Name:
Ethyl acetate
Cas Number:
141-78-6
Molecular formula:
C4H8O2
IUPAC Name:
ethyl acetate
Details on test material:
no data.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5-3.5kg
- Other: albino rabbits used.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Fur removed from entire trunk area by clipping
- % coverage:
- Type of wrap if used: impervious plastic film

OTHER
- Animals immobilised during exposure period.
Duration of exposure:
24 hours
Doses:
not specified
No. of animals per sex per dose:
4
Control animals:
other: no but a large number of other substances also tested which acted as reference materials.
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Mortality:
No data given on doses used or mortalities at respective dose levels. No information on times of death, symptoms or necropsy information.
Clinical signs:
other: No information on symptoms
Gross pathology:
No information on necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

In an acute dermal toxicity in rabbits in which key basic details were reported, an LD50 was not seen at the maximum tested dose of 20g/kg with exposure was under occluded conditions. The substance can be considered as not acutely toxic by the dermal route.

Synopsis

LD50>20g/kg