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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 246-495-9 | CAS number: 24851-98-7
Endpoint summary
Administrative data
Description of key information
Human Repeated Insult Patch Test (FDA-US), 100 humans tested (m+f, general poulation), no signs of irritation and sensitization (Klimish 1)
Human Repeated Insult Patch Test (FDA-US), 111 humans tested (m+f, general polulation), no signs of irritation and sensitization (Klimish 1)
Human Maximisation Test (no official guideline followed), 25 humans tested (f, 18-32 years old), no signs of irritation (Klimish 4)
Additional information
Human Repeated Insult Patch Test studies (HRIPT) is a study that can detect weak sensitizers that require multiple applications to induce a cell-mediated (Type IV) immune response sufficient to cause an allergic reaction. HRIPT isa reproducible, standardized, quantitative patch evaluation procedure generally accepted to demonstrate that a particular material can be applied safely to human skin without significant risk of adverse reactions.
Two HRIPTs covering the composition range of the substance were performed using a minimum of 100 appropriate human subjects (male + female, general population). There were no deviations from the test guideline (US-FDA) and both tests were selected as key study.
Under the conditions employed in this study, there was no evidence of both sensitization and irritation of the substance, even in rough test conditions, as occlusive testing is a severe condition improving dermal exposure & penetration, therefore facilitating dermal reactions.
A synopsis of a Human Maximization test performed on 25 people with the substance confirms the result of the HRIPTs.
In conclusion, the substance can be applied safely, at least to the concentration tested in that studies (20%), to human skin without significant risk of adverse reactions.
Table 1: Human Skin sensitization studies
Test Guideline |
Test concentrations |
N° of humans/ dose |
Klimishcode |
Result |
HRIPT |
20% in DEP |
100 (m+f) |
1 |
Not sensitizing in humans |
HRIPT |
20% in DEP/EtOH |
111 (m+f) |
1 |
Not sensitizing in humans |
Human Maximization Test |
10 % in withe petrolatum |
25 (f) |
4 |
Not sensitizing in humans |
HRIPT: Human Repeated Insult Patch Test DEP: DiethylPhtalate EtOH: Ethanol m/f: male/female |
||||
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.
