Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information
not relevant
Additional information

Methyl lactate is rapidly hydrolysed into lactic acid and methanol in vivo.

Lactic acid is a ubiquitous and essential molecule of life, found in all higher animals, and many micro-organisms. It is also found in many food items. Developmental toxicity is not a relevant end point for such a substance since there is no way of lowering exposure below minimum required levels or normal (or even abnormal) internal levels.

Methanol can elicit adverse effects on the reproductive system and on fertility and fecundability in males and females and can trigger developmental toxicity in females. However, it is clear that this occurs at levels that can only be achieved by deliberate oral consumption. In the context of potential exposure resulting from occupational or consumer use of methyl lactate resulting methanol exposure appears unlikely to present human health hazards.

Therefore, submitting a reprotox study is not relevant.


Short description of key information:
Methyl lactate is rapidly hydrolysed into lactic acid and methanol in vivo.
Lactic acid is a ubiquitous and essential molecule of life, found in all higher animals, and many micro-organisms. It is also found in many food items. Developmental toxicity is not a relevant end point for such a substance since there is no way of lowering exposure below minimum required levels or normal (or even abnormal) internal levels.
Methanol can elicit adverse effects on the reproductive system and on fertility and fecundability in males and females and can trigger developmental toxicity in females. However, it is clear that this occurs at levels that can only be achieved by deliberate oral consumption. In the context of potential exposure resulting from occupational or consumer use of methyl lactate resulting methanol exposure appears unlikely to present human health hazards.
Therefore, submitting a reprotox study is not relevant.

Effects on developmental toxicity

Description of key information
Ethyl lactate is rapidly hydrolysed into lactic acid and ethanol in vivo.
Lactic acid is a ubiquitous and essential molecule of life, found in all higher animals, and many micro-organisms. It is also found in many food items. Developmental toxicity is not a relevant end point for such a substance since there is no way of lowering exposure below minimum required levels or normal (or even abnormal) internal levels.
In extremis, ethanol can elicit adverse effects on the reproductive system and on fertility and fecundability in males and females and can trigger developmental toxicity in females. However, it is clear that this occurs at Body Ethanol Levels that can only be achieved by deliberate oral consumption of alcoholic beverages. In the context of potential exposure resulting from occupational or consumer use of ethyl lactate resulting ethanol exposure appears unlikely to present human health hazards.
Therefore, submitting a developmental toxicity study is not relevant.
Effect on developmental toxicity: via dermal route
Dose descriptor:
NOAEL
3 619 mg/kg bw/day
Additional information

Ethyl lactate is rapidly hydrolysed into lactic acid and ethanol in vivo.

Lactic acid is a ubiquitous and essential molecule of life, found in all higher animals, and many micro-organisms. It is also found in many food items. Developmental toxicity is not a relevant end point for such a substance since there is no way of lowering exposure below minimum required levels or normal (or even abnormal) internal levels.

Neither ethyl lactate nor ethylhexyl lactate show signs of developmental toxicity in appropriate tests. Read across to other alkyl chain lactic acid esters is possible. Methyl lactate is not expected to be a developmental toxicant.

Justification for classification or non-classification

Ethyl lactate is rapidly hydrolysed into lactic acid and ethanol in vivo.

Lactic acid is a ubiquitous and essential molecule of life, found in all higher animals, and many micro-organisms. It is also found in many food items. Developmental toxicity is not a relevant end point for such a substance since there is no way of lowering exposure below minimum required levels or normal (or even abnormal) internal levels.

In extremis, ethanol can elicit adverse effects on the reproductive system and on fertility and fecundability in males and females and can trigger developmental toxicity in females. However, it is clear that this occurs at Body Ethanol Levels that can only be achieved by deliberate oral consumption of alcoholic beverages. In the context of potential exposure resulting from occupational or consumer use of ethyl lactate resulting ethanol exposure appears unlikely to present human health hazards.

Therefore, no classification for effects on fertility and developmental toxicity/teratogeniticy is required.

Additional information