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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 903-982-7 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Supporting study. Test method similar to OECD guideline 406. The substance was no sensitizing.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- (A scientific review (peer reviewed). No data on GLP)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- A human maximization study was carried out with 5% (3450 µg/cm2) fenchyl acetate in petrolatum on 25 (10 male:15 female) healthy volunteers. The author of the study report is Dr. Klingman - coauthor of the maximization test adopted by OECD.
- GLP compliance:
- not specified
- Type of study:
- other: Human maximization test
- Species:
- human
- Sex:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5 % (3450 µg/cm2)
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5 % (3450 µg/cm2)
- No. of animals per dose:
- 25 (10 male:15 female) healthy volunteers.
- Details on study design:
- Application was under occlusion to the same site on the forearms of all subjects for five alternate-day 48-hour periods. Patch sites were pretreated for 24 h with 5% aqueous sodium lauryl sulfate (SLS) under occlusion. Following a 10 day rest period, challenge patches were applied under occlusion to fresh sites for 48 h. Challenge applications were preceded by 1-hour applications of 10% aqueous SLS under occlusion. Challenge sites were read on removal of the patch and 24 h thereafter.
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- test chemical
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: Not classified (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The substance was no sensitizing.
- Executive summary:
A human maximization (Kligman, 1966) study was carried out with 5% (3450 µg/cm2) fenchyl acetate in petrolatum on 25 (10 male:15 female) healthy volunteers. Application was under occlusion to the same site on the forearms of all subjects for five alternate-day 48-hour periods. Patch sites were pretreated for 24 h with 5% aqueous sodium lauryl sulfate (SLS) under occlusion. Following a 10 day rest period, challenge patches were applied under occlusion to fresh sites for 48 h. Challenge applications were preceded by 1-hour applications of 10% aqueous SLS under occlusion. Challenge sites were read on removal of the patch and 24 h thereafter. No sensitization reactions (0/25) were observed.
Reference
No sensitization reactions (0/25) were observed.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Supporting study. A human maximization (Kligman, 1966) study was carried out with 5% (3450 µg/cm2) fenchyl acetate in petrolatum on 25 (10 male:15 female) healthy volunteers. Application was under occlusion to the same site on the forearms of all subjects for five alternate-day 48-hour periods. Patch sites were pretreated for 24 h with 5% aqueous sodium lauryl sulfate (SLS) under occlusion. Following a 10 day rest period, challenge patches were applied under occlusion to fresh sites for 48 h. Challenge applications were preceded by 1-hour applications of 10% aqueous SLS under occlusion. Challenge sites were read on removal of the patch and 24 h thereafter. No sensitization reactions (0/25) were observed.
Justification for classification or non-classification
One of the impurities of this multiconstituent substance, dipentene, is included in Table 3 of Annex VI of CLP Regulation (harmonised classification and labelling) and it is classified as:
Skin Sensitizer Category 1, H317.
Taking into account that the concentration of this impurity is higher than 1%, the substance is classified as:
Skin Sensitizer Category 1, H317.
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.
