Registration Dossier
Registration Dossier
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EC number: 203-288-8 | CAS number: 105-34-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Methyl cyanoacetate
- EC Number:
- 203-288-8
- EC Name:
- Methyl cyanoacetate
- Cas Number:
- 105-34-0
- Molecular formula:
- C4H5NO2
- IUPAC Name:
- methyl 2-cyanoacetate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Hsd/Cpb:WU (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Age at study initiation: not stated in the report
- Weight at study initiation: 200-300 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 19.06.1995 To: 06.07.1995
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 10% of the skin surface of the animal
- Type of wrap if used: gauze bandaging secured with tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): corn oil MEH 56
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.77 ml/kg bw
- Concentration (if solution): undiluted test substance
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations (mortality, clinical signs): at 0.5, 1, 2, 3, 4, 5 and 6 h after dosing and once daily thereafter
- Frequency of weighing: day 0 (prior to dosing), day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: gross examination of organs at necropsy, organ weights
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: No clinical signs, including local skin reactions, were observed.
- Gross pathology:
- No substance-related alerations were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- In this acute dermal toxicity study in the rat a combined LD50 value of >2000 mg/kg bw was derived.
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