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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 221-043-3 | CAS number: 2983-37-1
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1982
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
- Type of sensitisation studied:
- skin
Test guideline
- Qualifier:
- no guideline followed
Method
- Type of population:
- general
- Subjects:
- 29 healthy, male and female volunteers
- Route of administration:
- dermal
- Details on study design:
- A maximization test was carried out with test material at 12% in petrolatum on 29 healthy, male and female volunteers.
Application was done 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 hours with 7.5% aqueous sodium lauryl sulfate (SLS) under occlusion for the initial patch only.
Following a ten to fourteen day rest period, challenge patches were applied at 12% under occlusion to fresh sites for 48 hours.
Challenge applications were preceded by 30 minute applications of 7.5% aqueous SLS under occlusion on the left side whereas the test material was applied without SLS treatment on the right side. A fifth site challenged with petrolatum served as control.
Results and discussion
- Results of examinations:
- No effects
Applicant's summary and conclusion
- Conclusions:
- under the conditions of this test, no sensitization effects were observed
- Executive summary:
A maximization test was conducted using 12% test material in petrolatum. Occluded applications were made to the same site on the forearms of 29 subjects for five alternate-day 48 hour periods.
Patch sites were pretreated for 24 hours with 7.5% aqueous sodium lauryl sulfate (SLS) under occlusion for the initial patch only.
Following a ten to fourteen day rest period, challenge patches were applied under occlusion to fresh sites for 48 hours.
Challenge applications were preceded by 30 minute applications of 7.5% aqueous SLS under occlusion on the left side whereas the test material was applied without SLS treatment on the right side. A fifth site challenged with petrolatum served as control. No sensitization effects were observed.
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.
