Registration Dossier
Registration Dossier
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EC number: 232-444-8 | CAS number: 8030-55-5 Extractives and their physically modified derivatives. It consists primarily of resins, essential oils, and usually cinnamic and benzoic acids. (Dipterocarpus, Dipterocarpaceae).
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Test was conducted according to methods similar to OECD guideline 402 (limit test) and was performed pre-GLP. A concise description of the protocol is available and results are reported clearly.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- Limit test
- GLP compliance:
- no
- Remarks:
- pre-GMP
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Gurjon oil
- IUPAC Name:
- Gurjon oil
- Details on test material:
- - Name of test material (as cited in study report): Gurjon oil
- Lot/batch No.: Confidential information
- Purity: No data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: not specified
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg
- Duration of exposure:
- 24h
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 10 animals per dose, sex not specified
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
Results and discussion
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- none
- Clinical signs:
- other: none
- Gross pathology:
- no effects reported
- Other findings:
- none
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Remarks:
- Based on CLP
- Conclusions:
- The dermal LD50 value of Gurjun oil in rabbits was established as exceeding 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not need to be classified according to the classification criteria outlined in annex 1 of CLP Regulation 1272/2008/EC (CLP).
- Executive summary:
10 Rabbits were dermally exposed to 5000 mg/kg bw dose of Gurjun oil. The animals were observed for 14 days. No symptoms or mortality were noted. The dermal LD50 value of Gurjon oil in rabbits was established as exceeding 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not have to be classified according to the classification criteria outlined in annex 1 of the CLP Regulation 1272/2008/EC.
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