Registration Dossier
Registration Dossier
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EC number: 294-461-7 | CAS number: 91722-61-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Juniperus mexicana, Cupressaceae.
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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 2017
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-GLP
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Juniper, Juniperus mexicana, ext.
- EC Number:
- 294-461-7
- EC Name:
- Juniper, Juniperus mexicana, ext.
- Cas Number:
- 91722-61-1
- Molecular formula:
- Not available since an UVBC substance.
- IUPAC Name:
- Essential oil of Cedarwood Texas obtained from the wood of Juniperus mexicana (Cupressaceae) by distillation
- Test material form:
- liquid
- Details on test material:
- CAS 91722-61-1
For specific details on test material if available - See in RSS
Name of test material (as cited in study report or in reference): Cedarwood Texas oil
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: EOA 75-12
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Not Specified
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- 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.
- 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 the CLP Regulation (1272/2008/EC).
- Conclusions:
- The dermal LD50 value of Cedarwood Texas 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 Cedarwood Texas Oil. The animals were observed for 14 days. No symptoms or mortality were noted. The dermal LD50 value of Cedarwood Texas Oil in rabbits was established as exceeding 5000 mg/kg body weight, under the conditions of this study.
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