Registration Dossier
Registration Dossier
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EC number: 202-510-0 | CAS number: 96-49-1
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 17-June 19,1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study was performed according to following guidelines: OECD 402, EU Method B.3 and in compliance with GLP Regulations (German and OECD). No significant deviations can be observed from the study guidelines, which could have an impact on the performed study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- stability not reported
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- German Principles of GLP (1994), OECD, GLP regulations (1983)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Ethylene carbonate
- EC Number:
- 202-510-0
- EC Name:
- Ethylene carbonate
- Cas Number:
- 96-49-1
- Molecular formula:
- C3H4O3
- IUPAC Name:
- 1,3-dioxolan-2-one
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Ethylene carbonate
- Purity: > 99%
- Physical state: fine crystals
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstraße 27, 33176 Borchen
- Age at study initiation: adult
- Weight at study initiation: 200-300g
- Fasting period before study: no data
- Housing: in Makrolon type Ill cages, each cage containing one rat
- Diet (e.g. ad libitum): Ssniff R 10 diet in pelletform (laboratory standard rat diet), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: min.5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12h light, 12h dark
IN-LIFE DATES: From: 18-04-1996 To: 02-05-1996 (males), From: 05-06-1996 To : 16-05-1996 (females)
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorso-lumbar region (clipped free of fur)
- % coverage: app. 10%
- Type of wrap if used: no
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with cleaned corn oil and absorbent paper
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 10 (5 males and 5 females)
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: at least twice daily; weighing: day 0 , 7 , 14
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight, dermal response, macroscopic examination - Statistics:
- not applicable
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no mortality observed
- Mortality:
- -no deaths following a single dermal application of Ethylene Carbonate at 2000 mg/kg bw
- Clinical signs:
- other: - no signs of systemic reaction to treatment
- Gross pathology:
- -no macroscopic abnormalities were observed for animals killed on day 14
- Other findings:
- -no local dermal irritations at the treatment site were observed following removal of the dressings until the end of the observation period
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute lethal dermal dose to rats of Ethylene carbonate was found to be greater than 2000 mg/kg bw.
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