Registration Dossier
Registration Dossier
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EC number: 300-338-1 | CAS number: 93925-36-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
The key information is a resultant of weight of evidence evaluation based on two sources concerning alkyl lactate esters.
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Based on read-across and weighed evidence of studies with lactate analogues and the direct metabolites.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 200 mg/m³
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Not assignable.
Effect on fertility: via dermal route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 3 619 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Not assignable.
Additional information
These studies are the most representative of the list of studies used as weighed evidence.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on weighed evidence data of studies with analogue alkyl lactates and the direct metabolites (fatty alcohols), there is no evidence of potentially adverse effects on reproductive parameters due to exposure to the product containing both long chain alkyl lactates and fatty alcohols. Hence, there is no reason for classification as hazardous for reproduction.
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.
