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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995-04-12 to 1995-05-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopropenyl acetate
EC Number:
203-562-7
EC Name:
Isopropenyl acetate
Cas Number:
108-22-5
Molecular formula:
C5H8O2
IUPAC Name:
isopropenyl acetate
Details on test material:
Name: Isopropenylacetate
Batch No.: 75/95
Chemical name: 1-Propen-2-ol, acetate
Physical state: clear watery liquid
Purity: 99.5%
Density: 0.93 g/ml
Storage: ambient, protected from light
Stability: till September 3, 1995

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Species:rat
Strain:Hsd/Cpb:WU
Source:Fa. Harlan Winkelmann GmbH, Gartenstr.27, 33178 Borchen
Date of receipt: March 8, 1995 (range finding; main test, females), March, 23, 1995 (main test, males)
Acclimatization period: at least 5 days
Animal selection: random
Animal identification:
with colored markings; cage labelled with dosage, sex, date of study initiation, project no
Weight range at study initiation: m: 271 - 289 g, f: 197 - 236 g

Housing: individual housing in cages (Makrolon type 11)
Illumination: artificial lighting (120 lux) from 7.00 a.m. - 7.00 p.m.
Temperature:22 ± 3 °C
Relative humidity: 30 -70 %
Measurement: twice daily








.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
A single dermal application of the test article was performed. The substance was held in contact with the skin with a porous gauze dressing and Elastoplast (Beiersdorf). The exposure period was 24 h. The test article was applied undiluted in a volume of 2.15 ml/kg.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
In each animal a number of clinical-toxicological signs were evaluated according to a modified Irwin-Screening procedure (Screening Methods in Pharmacology, R. A. Turner, 1965, p. 26). The animals were examined at the following post-treatment intervals: 10 min, 1 h, 2 h, 6 h, 24 h, and thereafter once daily up to day 14.
Statistics:
not reported

Results and discussion

Preliminary study:
no mortality at 2000 mg/kg
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: none
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Remarks on result:
other: none
Mortality:
no mortality was observed
Clinical signs:
no effects
Body weight:
Weight gains were normal in all animals.
Gross pathology:
no effects
Other findings:
No signs of erythema or oedema were observed.

Applicant's summary and conclusion

Interpretation of results:
relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Substance has a dermal LD 50 of > 2000 mg/kg bw
Executive summary:

An acute dermal toxicity study of isopropenyl acetate (99.5% pure) was conducted in the Wistar Hsd/Cpb:Wu rat in accordance with OECD Guideline 402 which yielded a dermal LD50 of > 2000 mg/kg body weight. Single 24 h semi-occlusive application of 2000 mg isopropenyl acetate/kg bw to the depilated dorsal skin of 5 males and 5 females was tolerated without remarkable findings. During the subsequent 14 days observation period, no animal dies, no skin changes or clinical signs were observed and body weight gain was normal. Terminal necropsy was without abnormal findings.