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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 500-311-6 | CAS number: 120498-03-5
Endpoint summary
Administrative data
Description of key information
The repeated toxicity was investigated with a Sub-chronic (13 week) oral toxicity study in rats following the FDA guideline for testing food addtives (Toxicological Principles for the Safety Assessment of Direct Food Additives and Colour additives used in food; US Food and Drug Administration Bureau of Foods, 1982). The study was performed in GLP.
20 females and 20 males per dose group were treated at the following doses: 5, 13 and 24 mg/kg b.w.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 24 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
The dietary administraion of UVASORB HA88 for 13 weeks to rats did not cause any changes nasopharynx, lungs, mediastinal lumph nodes, liver and meenteric lymph nodes. No test substance particles were encountered in any organ examined. Also, in none of these organs foreign body reaction was seen.
Justification for classification or non-classification
Basing on the results above reported, REGULATION (EC) No 1272/2008 (EU Regulation on Classification, Labelling and Packaging of substances and mixtures) would indicate the following:
Repeated Toxicity
Classification : Not classified
Signal word : -
Hazard statement (Oral) : -
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.
