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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 208-401-4 | CAS number: 526-95-4
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitisation potential of gluconic acid was assessed in a GLP-compliant study performed according to OECD Guidelines for the Testing of Chemicals No. 429 (local lymph node assay) (Bradshaw, 2009). In the main study, groups of 4 mice were tested with the undiluted test material or diluted test material at concentrations of 50 or 25% v/v in dimethyl formamide. The mice were treated daily with an application of 25 µL of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days. Another group of four mice received the vehicle alone in the same manner. Five days following the first topical application of the test material all mice were injected via the tail vein with 250 µL of phosphate buffered saline containing 3H-methyl thymidine (3HTdR). Five hours following the administration of 3HTdR all mice were killed. A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation. The incorporation of 3HTdR was counted by beta-scintillation. Since treatment with the test material did not result in at least a 3-fold or greater increase in 3HTdR incorporation compared to control values, the test substance was considered to be non-sensitising under the conditions of the test. In addition, there were no deaths and no signs of systemic toxicity reported, and body weight changes between Day 1 and Day 6 were similar among test and control animals.
Migrated from Short description of key information:
Gluconic acid was reported to be non-sensitising to skin in a local lymph node assay conducted in mice in a GLP-compliant study performed according to test guidelines.
Justification for classification or non-classification
The substance does not meet the criteria for classification and labelling for this endpoint, as set out in Regulation (EC) NO. 1272/2008.
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.
