Registration Dossier

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
Justification for selection of Effect on fertility via oral route:
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.