Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
600 mg/m³
Study duration:
subacute
Species:
rat
Quality of whole database:
Based on tests with shorter chain alkyl lactates.

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEC
75 mg/m³
Study duration:
subacute
Species:
rat
Quality of whole database:
Based on tests with shorter chain alkyl lactates.

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
500 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Low (not assignable).

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Study duration:
subacute
Species:
rat
Quality of whole database:
Low (not assignable).

Additional information

Justification for classification or non-classification

The effect concentration for an analogue of alkyl lactates ( 2-ethylhexyl-L-lactate) was above the classification limit of 0.2 mg/L (> 200 mg/m³) for inhalatory exposure of aerosol or mist. Local effects of repeated respiratory exposure to a concentration of 75 mg/m³ included slight focal hyperplasia of the nasal respiratory epithelium, including hyperplasia of goblet cells. In case of dermal exposure, the effect concentration for an analogue of alkyl lactates (Cetyl lactate) was above the classification limit of 200 mg/kg bw/d (> 500 mg/kg bw/d).