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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- 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. .
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- 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.
- Justification for type of information:
- Three in vivo skin irritation studies with 3 different NCSs showed that these could be considered irritating, while the study with orange oil did not result in skin irritation. D-Limonene is also known to be irritating. As D-limonene is present in all NCSs of this group at levels higher than the 20% threshold mentioned in the classification and labelling directive (1999/45/EC, DPD and 1272/2008/EC, CLP and as three studies showed evidence of skin irritation, these results are read across to the other NCSs and the whole group is considered irritating to the skin and classified as R38 or H315.
See also attached justification. - Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- other: Slight redness
- Basis:
- other: 6 out of 10 rabbits
- Time point:
- other: No information
- Remarks on result:
- other: No information on scoring system
- Irritation parameter:
- other: Moderate redness
- Basis:
- other: 2 out of 10 rabbits
- Time point:
- other: No information
- Remarks on result:
- other:
- Remarks:
- No information on scoring system
- Irritation parameter:
- other: Slight edema
- Basis:
- other: 7 out of 10 rabbits
- Time point:
- other: No information
- Remarks on result:
- other:
- Remarks:
- No information on scoring system
- Irritation parameter:
- other: Moderate edema
- Basis:
- other: 3 out of 10 rabbits
- Time point:
- other: No information
- Remarks on result:
- other:
- Remarks:
- No information on scoring system
- Other effects:
- No Symptomatology. Mortality: 1 out of 10 rabbbits died.
- Interpretation of results:
- moderately irritating
- Remarks:
- 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.
Slight redness - 6/10
Moderate redness - 2/10
Slight edema - 7/10
Moderate edema - 3/10
No information on scoring system used.
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
Resultsopen allclose all
- Irritation parameter:
- other: Slight redness
- Basis:
- other: 6 out of 10 rabbits
- Time point:
- other: No information
- Remarks on result:
- other: No information on scoring system
- Irritation parameter:
- other: Moderate redness
- Basis:
- other: 2 out of 10 rabbits
- Time point:
- other: No information
- Remarks on result:
- other:
- Remarks:
- No information on scoring system
- Irritation parameter:
- other: Slight edema
- Basis:
- other: 7 out of 10 rabbits
- Time point:
- other: No information
- Remarks on result:
- other:
- Remarks:
- No information on scoring system
- Irritation parameter:
- other: Moderate edema
- Basis:
- other: 3 out of 10 rabbits
- Time point:
- other: No information
- Remarks on result:
- other:
- Remarks:
- No information on scoring system
- 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:
- 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
