Registration Dossier
Registration Dossier
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EC number: 947-090-6 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Cystus concrete and Cyste absolute are obtained from the same botanical source, the Cistus ladaniferus (Cistaceae).
- Reason / purpose for cross-reference:
- read-across source
- Principles of method if other than guideline:
- Standard acute method (limit test)
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- No data
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on dermal exposure:
- No data
- Duration of exposure:
- No data
- Doses:
- 5 000 mg/kg bw
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- No data
- Preliminary study:
- No data
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortality
- Clinical signs:
- No data
- Body weight:
- No data
- Gross pathology:
- No data
- Other findings:
- The test material adhered tightly to the skin and could not be removed with standard washing procedures. the skin surface was therefore obscured and initial erythema would have escaped detection.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS. Therefore, the registered substance is not considered toxic by dermal route.
- Executive summary:
In an acute dermal toxicity study (limit test), rabbits were given a single dermal application of the test item at 5000 mg/kg bw. Animals were observed for mortality and clinical signs for 14 days.
No mortality or clinical signs was observed.
In this study, the dermal LD50 of the test item was higher than 5000 mg/kg bw in rats.
Under the experimental conditions of this study, the test item is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS. Therefore, the registered substance is not considered toxic by dermal route.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
- Principles of method if other than guideline:
- Standard acute method (limit test)
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Labdanum
- EC Number:
- 283-893-1
- EC Name:
- Labdanum
- Cas Number:
- 84775-64-4
- IUPAC Name:
- Cyste absolute
- Test material form:
- not specified
- Details on test material:
- RIFM ID 358
Constituent 1
- Specific details on test material used for the study:
- No data
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on dermal exposure:
- No data
- Duration of exposure:
- No data
- Doses:
- 5 000 mg/kg bw
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- No data
Results and discussion
- Preliminary study:
- No data
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- No data
- Body weight:
- No data
- Gross pathology:
- No data
- Other findings:
- The test material adhered tightly to the skin and could not be removed with standard washing procedures. the skin surface was therefore obscured and initial erythema would have escaped detection.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
- Executive summary:
In an acute dermal toxicity study (limit test), rabbits were given a single dermal application of the test item at 5000 mg/kg bw. Animals were observed for mortality and clinical signs for 14 days.
No mortality or clinical signs was observed.
In this study, the dermal LD50 of the test item was higher than 5000 mg/kg bw in rats.
Under the experimental conditions of this study, the test item is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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