Registration Dossier
Registration Dossier
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EC number: 203-533-9 | CAS number: 107-93-7
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-08-22 to 2012-09-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- trans-crotonic acid
- EC Number:
- 203-533-9
- EC Name:
- trans-crotonic acid
- Cas Number:
- 107-93-7
- Molecular formula:
- C4H6O2
- IUPAC Name:
- but-2-enoic acid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: DEBR 012553
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90
- Age at study initiation: Young adult rats, females were nulliparous and non-pregnant
- Weight at study initiation: 274-282 g (male), 239-265 g (female)
- Housing:animals were housed individually.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 47 days (females) and 5 days (males)
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Air changes (per hr):8-12 air exchanges/hour by central air-condition system
- Photoperiod (hrs dark / hrs light): Artificial light, from 6 am. to 6 pm
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: approximately 10 % of the total body surface area
- Type of wrap if used: semi-occlusive plastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing:using body temperature water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount applied:The test item was uniformly applied in a single dose to at least 10 % of the total body surface area
- For solids, paste formed: yes - Duration of exposure:
- 24 hours
- Doses:
- Pretest: 5, 50, 300 and 2000 mg/kg bw dose levels, Maintest: 2000 mg/kg bw
- No. of animals per sex per dose:
- Pretest: 2 female animals
Maintest: 5 female and 5 male animals - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs: individually 1 h and 5 h after dosing, and once each day for 14 days
Body weight: shortly before treatment (pretest) and shortly before treatment, on day 7 and on day 15 (maintest)
- Other examinations performed: gross pathology
Results and discussion
- Preliminary study:
- There were no deaths in preliminary study at 5, 50, 300 and 2000 mg/kg bw dose levels
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality
- Clinical signs:
- other: Neither male nor female animals treated at 2000 mg/kg bw showed behavioural changes and no systemic toxic signs were noted during the study. The test item caused dermal irritation symptoms as slight erythema, wounds and crusts that was fully reversible at
- Gross pathology:
- No macroscopic alterations of organs and tissues referred to the systemic toxic effect of the test item were seen during the necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present acute dermal toxicity study with the test item Crotonic acid, the obtained acute dermal LD50 value was greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats.
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