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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 246-376-1 | CAS number: 24634-61-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Species:
- rat
- Quality of whole database:
- acceptable
Additional information
A recent two-generation reproduction toxicity study of Sorbic acid following oral administration to rats, carried out in 2004 according to the guidelines of the OECD 416 (2001), EC method B.35 (88/302/EEC) and IV.C.9.a. Guidelines for Reproduction Studies, FDA Redbook (2000), also showed no effects on reproduction parameters up to the highest dose of 3 000 mg/kg bw/d.
The extrapolation from sorbic acid to potassium sorbate is considered not to be restricted in any way, since the determinant of potential toxicity is the "sorbate" anion.
Short description of key information:
A 2-generation reproductive toxicity study of sorbic acid via oral
administration on rats and 3 teratogenecity studies, one in rabbits with
sorbic acid and two in pregnat mice and rats with potassium sorbate were
conducted. Collectivelly, observations showed no teratogenic effects.
Justification for selection of Effect on fertility via oral route:
Well conducted and according to the guidelines of the OECD 416
(2001), EC method B.35 (88/302/EEC).
In addition, an extended one generation reproductive toxicitiy study (OECD 443) was conducted upon recomendation by EFSA. A NOAEL for systemic toxicity and reporductive performance in the adult parental animals and for offspring was established at 30000ppm.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Species:
- rabbit
- Quality of whole database:
- acceptable
Additional information
No treatment-related maternal or developmental effects were observed at 300 mg/kg/day in rabbits administered Sorbic Acid.
No teratogenic effects have been observed in pregnant mice and rats administered Potassium Sorbate. Mice were administered Potassium Sorbate at doses of 4.6-460.0 mg/kg body weight, while the rats received doses of 3.4-340.0 mg/kg body weight. Doses were administered orally on days 6-15 of gestation. No significant effects were noted on nidation or on maternal or fetal survival in either mice or rats.
The extrapolation from sorbic acid to potassium sorbate is considered not to be restricted in any way, since the determinant of potential toxicity is on the "sorbate" anion.
Justification for selection of Effect on developmental
toxicity: via oral route:
well conducted and according to the guidelines of the OECD 414
(2001), EC method B.31 (1988)
Justification for classification or non-classification
According to regulation (EC) No 1272/2008, sorbic acid and potassium sorbate are not classified as reproductive toxicants.
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.
