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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 272-842-9 | CAS number: 68917-63-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- Freund's complete adjuvant test
- Justification for non-LLNA method:
- A FCAT guinea pigs study is available and reliable to determine the sensitization potential of the substance
Test material
- Reference substance name:
- Terpenes and Terpenoids, sinpine
- EC Number:
- 272-842-9
- EC Name:
- Terpenes and Terpenoids, sinpine
- Cas Number:
- 68917-63-5
- IUPAC Name:
- Reaction mass of 1-methyl-4-(propan-2-ylidene)cyclohex-1-ene and 1-methyl-4-(prop-1-en-2-yl)cyclohex-1-ene and 2,6,6-trimethylbicyclo[7.1.1]hept-2-ene and 1-isopropyl-4-methylcyclohexa-1,4-diene
- Test material form:
- not specified
1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: FCA
- Concentration / amount:
- 5%
- Day(s)/duration:
- 0, 4, 9 days
- Adequacy of induction:
- not specified
Challenge
- Route:
- epicutaneous, open
- Vehicle:
- not specified
- Concentration / amount:
- 1, 3 and 10%
- Day(s)/duration:
- 35 days
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 19
- Challenge controls:
- none
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- not relevant
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: single challenge
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 13
- Total no. in group:
- 19
- Clinical observations:
- not reported
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- other: single challenge
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 7
- Total no. in group:
- 19
- Clinical observations:
- not reported
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- other: single challenge
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 5
- Total no. in group:
- 19
- Clinical observations:
- not reported
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Challenge tests with the highest nonirritant and two lower concentrated alcoholic solutions of SinPine P three and five weeks after the initial intradermal injection are positive in 12/20, 8/20; 4/20 and 13/19, 7/19, 5/19 guinea pigs respectively.
Under conditions of the FCAT Sinine P is a moderate sensitizer for this animal species.
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.
