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Toxicological information

Specific investigations: other studies

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Administrative data

Endpoint:
specific investigations: other studies
Type of information:
other: expert statement
Adequacy of study:
supporting study
Study period:
2009
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Expert statement

Data source

Reference
Reference Type:
other: expert statement
Title:
Unnamed
Year:
2009

Materials and methods

Principles of method if other than guideline:
Investigation based on information (studies) provided by PURAC and information available in the public domain (literature).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Details on results:
The results presented make clear that lactate esters are rapidly hydrolysed by esterases in a number of mammalian tissues, including nasal olfactory epithelium, liver, skin, intestinal mucosa, and blood.

Applicant's summary and conclusion

Conclusions:
Data on the toxicity of lactic acid and the alcohols should play an important role when the human health hazards of lactate esters have to be assessed. Depending on anticipated routes and levels of exposure, they can make toxicity testing with the lactate esters themselves redundant
Executive summary:

The influence of hydrolysis of the esters on the systemic exposure was investigated by ENVIRON, based on information provided by PURAC and information available in the public domain. The information laid down in the report is meant to serve as a background document when information on the toxicological properties of lactic acid and the alcohols is used to supplement or substitute information on the esters themselves. The results presented make clear that lactate esters are rapidly hydrolysed by esterases in a number of mammalian tissues, including nasal olfactory epithelium, liver, skin, intestinal mucosa, and blood. Chemical hydrolysis is much slower. No data are as yet available on the hydrolysis of lactate esters under the conditions prevailing in the stomach (low pH). Rapid hydrolysis is not restricted to lactate esters, but has also been observed for a series of other esters, which are used as food flavours. Thus the results obtained with the lactate esters fit within a general pattern. It may be assumed that upon oral exposure at relatively low dose levels, systemic exposure to lactate esters consists largely, probably entirely of exposure to lactic acid and the alcohol. In particular, the esterase activity in the intestinal mucosa, the liver and the blood, will prevent any significant exposure to the parent ester when doses are low in comparison to the available esterase activity. The esterase activities in the skin and in the blood, also point to systemic exposure to lactic acid and alcohol upon dermal exposure. Taken together, data on the toxicity of lactic acid and the alcohols should play an important role when the human health hazards of lactate esters have to be assessed. Depending on anticipated routes and levels of exposure, they can make toxicity testing with the lactate esters themselves redundant.