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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 439-070-6 | CAS number: 125005-87-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 3 000 mg/kg bw/day
Additional information
Rats exposed to gellan gum at 5% in diet consumed the test diet at rates which declined over 10 weeks of treatment but were generally markedly above 3g test substance/kg/day:
- P generation males 6.0-3.0 g/kg/day, females 4.2-4.1 g/kg/day
- F1 generation males 6.5-2.8 g/kg/day, females 6.7-3.5 g/kg/day.
These high intakes had no detectable adverse effect on fertility (or development). It is reasonable to assume that Diutan, a biogum closely similar to gellan gum, would show a similar absence of toxicity to reproduction.
Short description of key information:
The close chemical analogue gellan gum has been tested for fertility/reproductive toxicity in a 2-generation rat feeding study. Exposure at levels up to 5% in diet (corresponding to intake in excess of 3g/kg/day in the highest exposure group) produced no evidence of treatment-related adverse effect on fertility or other reproductive parameters.
Effects on developmental toxicity
Description of key information
The close chemical analogue gellan gum has been tested for developmental toxicity in a rat teratology study. Exposure at levels up to 5% in diet (corresponding to intake of approximately 3.9g/kg/day in the highest exposure group) produced no evidence of maternal toxicity, embryo/foetal toxicity or developmental toxicity.
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 3 900 mg/kg bw/day
Additional information
Pregnant female rats exposed during the period of organogenesis to gellan gum at 5% in diet consumed the test diet at rates which corresponded to a mean daily intake of approximately 3.9 g test substance/kg/day. No significant maternal toxicity or adverse effects on indices of embryo/foetal toxicity or developmental parameters were seen.
It is reasonable to assume that Diutan, a biogum closely similar to gellan gum, would show a similar absence of developmental toxicity.
Justification for classification or non-classification
Reliable test data for a very close chemical analogue have demonstrated an absence of reproductive toxicity. No classification of Diutan for reproductive toxicity is therefore appropriate.
Additional information
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.
