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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 276-431-5 | CAS number: 72162-23-3 The high-boiling fraction separated by distillation from the products obtained from the reaction of nitric acid with cyclododecanol and cyclododecanone. Composed primarily of dodecanedioic acid, undecanedioic acid, and sebacic acid.
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
In a reproductive/developmental screening test (oral administration of 50; 100; 1000 mg/kg bw ) in rats no indication of adverse effects on development was noted. This is supported in a read-across approach data were considered from studies performed with the disodium salt of sebacic acid the C10 analog of dodecandioic acid with both rats and rabbits at dose levels of 500 and 1000 mg/kg bw/d, for rats and rabbits respectively.
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
No adverse effects on fertility were noted in a combined repeat dose reproductive toxicity test.
Also no adverse effects were noted on reproductive organs in other repeated dose studies.
Short description of key information:
A read-across reproductive/developmental screening test of dodecanedioic acid (oral administration of 50; 100; 1000 mg/kg bw ) in rats gave no indication of adverse effects on fertility or development .
Effects on developmental toxicity
Description of key information
Reproductive/developmental screening test (oral administration of 50; 100; 1000 mg/kg bw ) was performed in rats. No indication of adverse effects on development.
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
No developmental toxicity as observed in a screening test in rats at dose levels of up to 1000 mg/kg bw/day (4.3 mmol/kg bw/day) dodecanedioic acid.
Toxicity to reproduction: other studies
Additional information
No developmental toxicity was observed in a screening test in rats at dose levels of up to 1000 mg/kg bw/day (4.3 mmol/kg bw/day) dodecanedioic acid which is a major chemical in Corfree® M1.
This observation is supported by read-across to developmental toxicity studies with the disodium salts of C10 -homologue dicarboxylic acid, decanedioic acid (sebacic acid), at dose levels of 500 mg/kg bw/day (2.0 mmol/kg bw/day corresponding to 460.6 mg/kg bw/day dodecanedioic acid) in rats and 1000 mg/kg bw/day (4.06 mmol/kg bw/day corresponding to 935 mg/kg bw/day dodecanedioic acid) in rabbits where also a lack of developmental toxicity was demonstrated.Justification for classification or non-classification
No adverse effects were noted on fertility or development, therefore no classification regarding reproductive toxicity is required.
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.
