Registration Dossier
Registration Dossier
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EC number: 297-672-2 | CAS number: 93686-22-7 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus reticulata, x C. sinensis, Rutaceae.
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted according to methods similar to OECD 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:
- 1 971
- Report date:
- 1971
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Method described under Section 191.10 of the Final Order, Enforcement Regulations, Federal Register, Vol.26, No. 155, P. 7336, 12 August 1961
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Tangor, Murcote, ext.
- EC Number:
- 297-672-2
- EC Name:
- Tangor, Murcote, ext.
- Cas Number:
- 93686-22-7
- Molecular formula:
- This reference substance is a UVCB of the NCS type. It is a complex mixture of compounds and therefore molecular formula, molcular weight, and structural formula cannot be given.
- IUPAC Name:
- (4R)-1-methyl-4-(prop-1-en-2-yl)cyclohex-1-ene
- Test material form:
- liquid
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:
- no data
- Doses:
- 5.0 g/kg bw
- No. of animals per sex per dose:
- 6 (3 with intact skin, 3 with abraded skin)
- Control animals:
- not specified
- Details on study design:
- no data
- Statistics:
- no data
Results and discussion
- Preliminary study:
- not applicable
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 0/6
- Clinical signs:
- other: In 3 animals, dry cracked skin was noted.
- Gross pathology:
- no data
- Other findings:
- no data
Any other information on results incl. tables
| Dose (gram / kg) | No. Rabbits (Skin Intact) | Mortality | No. Rabbits (Skin Abraded) | Mortality |
| 5.0 | 3 | 0/3 | 3 | 0/3 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of tangerine oil in rabbits was > 5000 mg/kg bw under the conditions of this test.
- Executive summary:
To determine the percutaneous toxicity of Tangerine oil, an acute dermal toxicity study was performed on six albino rabbits according to a method described under Section 191.10 of the Final Order, Enforcement Regulations, Federal Register, August 1961. The LD50 of the test substance was > 5000 mg/kg bw. Therefore, the test substance does not have to be classified according to the EU classification criteria outlined in the CLP Regulation (1272/2008/EC).
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