Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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EC number: 277-143-2 | CAS number: 72968-50-4 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus aurantium, Rutaceae.
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study was not conducted according to a guideline or under GLP conditions. The report is concise but considered acceptable as basic data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Two rabbits were exposed dermally for 48 hours to 10 ml/kg Orange Bitter. Mortality was evaluated.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- orange oil bitter
- IUPAC Name:
- orange oil bitter
- Details on test material:
- - Name of test material (as cited in study report): Orange Bitter
- Lot/batch No.: confidential
Constituent 1
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:
- 48 hours
- Doses:
- 10 ml/kg = 8.5 g/kg (relative density 0.8504)
- No. of animals per sex per dose:
- 2 (sex unspecified)
- Control animals:
- not specified
- Details on study design:
- No data
- Statistics:
- Not relevant
Results and discussion
- Preliminary study:
- Not performed
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 8.5 mg/kg bw
- Based on:
- test mat.
- Remarks:
- (calculated with relative density)
- Remarks on result:
- other: Mortality: 0/2
- Mortality:
- No mortality observed
- Clinical signs:
- other: No data
- Gross pathology:
- No data
- Other findings:
- No data
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, a LD50 of >8.5 g/kg Orange Bitter was established.
- Executive summary:
Two rabbits were exposed dermally for 48 hours to 8.5 gkg Orange Bitter. No mortality was observed. Under the conditions of this study, a LD50 of >8.5 g/kg Orange Bitter was established.
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