Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

Short description of key information on bioaccumulation potential result: 
In accordance with REACh (Regulation (EC) No 1907/2006) Annex VIII section 8.8.1, a toxicokinetics study is not required as assessment of the toxicokinetic behaviour of the substance has been derived from the relevant available information. This assessment is located within the endpoint summary for toxicokinetics, metabolism and distribution.

Key value for chemical safety assessment

Additional information

Lactic acid is a major component of corn steep liquor (CSL).

Considering the physicochemical properties of lactic acid [i.e., low molecular weight (90.0774 g/mol) and negative log Pow value (-0.72)], absorption via the inhalation, oral, and dermal routes is expected to be high. Given the low vapour pressure of 0.0813 mm Hg (approximately 0.010 kPa) at room temperature, exposure via inhalation is likely to be of low relevance. Nonetheless, the presence of lethargy in the acute inhalation study in rats [1] supports the contention that the substance can be absorbed via the respiratory route. Absorption via the oral route is supported by clinical and histopathological findings in rats following administration of acute high doses of lactic acid that included ataxia, prostration, irregular breathing, and loose stools [2,3]. Chronic (2-year) administration of calcium lactate in the drinking water of rats resulted in no gross or histopathological changes [4]. Acute dermal exposure of rabbits to lactic acid did not result in any systemic effects [5], suggesting that dermal absorption may be low. For the purposes of risk assessment, however, given the lack of information for this route of exposure, dermal absorption is considered to potentially be 100%.

 

Lactic acid is a normal intermediary of mammalian metabolism and has well-established metabolic pathways after normal consumption in humans. It arises from glycogen breakdown, from amino acids, and from dicarboxylic acids such as succinate. Given all of the above, and the fact that lactic acid is readily excreted in the urine, it is not expected that lactic acid will bioaccumulate to any degree.

References

[1] Unknown, 1987 (cited in HPV dataset)

[2] Unknown, 1984 (cited in HPV dataset)

[3] Unknown, 1983 (cited in HPV dataset)

[4] Maekawa et al., 1991

[5] Unknown, 1983 (cited in HPV dataset)