Registration Dossier
Registration Dossier
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EC number: 203-562-7 | CAS number: 108-22-5
Acute Toxicity: dermal
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:
- 1 995
- 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
- 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
Constituent 1
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:
- other: no effects
- 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.
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