Registration Dossier
Registration Dossier
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EC number: 284-521-0 | CAS number: 84929-38-4 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus nobilis, Rutaceae.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Study period:
- July 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- 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 acceptable as basic data. Furthermore, due to the read-across purpose it was given a Klimisch 2 rating, in accordance with the ECHA Practical guide #6 on the reporting of read-across in IUCLID. The justification for read across is provided in the attached background material of the chapter summary.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In this skin irritation test of Grapefruit Oil 10 rabbits were used. There are no data on the test system and study design. Mortality, symptomatology, and skin irritation are recorded.
- GLP compliance:
- no
- Remarks:
- pre-GLP
Test material
- Reference substance name:
- Grapefruit oil
- IUPAC Name:
- Grapefruit oil
- Details on test material:
- - Name of test material (as cited in study report): 73-21 Grapefruit oil
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Duration of treatment / exposure:
- No data
- Observation period:
- No data
- Number of animals:
- 10
Results and discussion
In vivo
- Other effects:
- No Symptomatology. Mortality: 1 out of 10 rabbbits died.
Any other information on results incl. tables
Slight redness - 6/10
Moderate redness - 2/10
Slight edema - 7/10
Moderate edema - 3/10
No information on scoring system used.
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Skin irritation results are as follows: Slight redness - 6/10; Moderate redness - 2/10; Slight edema - 7/10; Moderate edema - 3/10. No information on scoring system used is given. Based on these results, the substance is considered moderately irritating.
- Executive summary:
- In this skin irritation test of Grapefruit Oil 10 rabbits were used. No guideline has been followed and there are no data on the test system and study design. Mortality, symptomatology, and skin irritation are recorded. No symptoms have been observed. 1 out of 10 rabbits died. Skin irritation results are as follows: Slight redness - 6/10; Moderate redness - 2/10; Slight edema - 7/10; Moderate edema - 3/10. No information on scoring system used is given. Based on these results, the substance is considered moderately irritating.
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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