Formic acid, manufacture of, by-products from

Endpoint summary

Description of key information

Skin sensitisation data are available for the components.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The reaction mass of 2,2-bis(formyloxymethyl)propane-1,3-diyl diformate and formic acid consists of formic acid, propylidynetrimethanol-esters and pentaerythritol-esters. The toxicity of the propylidynetrimethanol-esters and pentaerythritol-esters is predicted to be comparable to propylidynetrimethanol and pentaerythritol respectively. Data from skin sensitisation studies on formic acid, propylidynetrimethanol and pentaerythritol are considered appropriate to meet the REACH Annex VII-X data requirements for the reaction mass of 2,2-bis(formyloxymethyl)propane-1,3-diyl diformate and formic acid.

Formic acid

The skin sensitisation potential of formic acid has been evaluated in guinea pigs using the Buehler test, conducted according to OECD Test Guideline 406 (BASF, 2002). None of the 20 Guinea pigs of the test group developed contact dermatitis when treated with formic acid in distilled water (concentration: 7.5 % during induction and 2% durig challenge). No skin sensitising effects were observed in the study.

Propylidynetrimethanol

The skin sensitisation potential of propylidynetrimethanol has been evaluated in a modified local lymph node assay (LLNA/IMDS – Intergrated Model for the Differentiation of Skin Reactions) in mice conducted according to OECD Test Guideline 429 (Bayer, 2010). In the study, propylidynetrimethanol was tested in mice at concentrations between 2 and 50 %. No sensitising potential was observed at doses up to 50%. No indication of non-specific (irritant) activation was detected in the study.

Pentaerythritol

No evidence of skin sensitisation was seen in a Local Lymph Node Assaa (LLNA).

The reaction mass of 2,2-bis(formyloxymethyl)propane-1,3-diyl diformate and formic acid

Formic acid does not have the potential to cause skin sensitisation. In addition, neither propylidynetrimethanol nor pentaerythritol have the potential to cause skin sensitisation. Based on read-across, propylidynetrimethanol-esters and pentaerythritol-esters are similarly predicted to lack the potential for skin sensitsation. Due to the lack of skin sensitation potential demonstrated for its components, the reaction mass of 2,2-bis(formyloxymethyl)propane-1,3-diyl diformate and formic acid is also predicted to lack skin sensitisation potential.

Migrated from Short description of key information:
Formic acid, propylidynetrimethanol and pentaerythritol do not have the potential to induce skin sensitisation based on skin sensitisation studies or read-across. On this basis, the reaction mass of 2,2-bis(formyloxymethyl)propane-1,3-diyl diformate and formic acid is not predicted to have any skin sensitisation potential.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

No skin sensitising effects were observed in sensitisation studies conducted using formic acid, propylidynetrimethanol or di-pentaerythritol. No skin sensitisation potential is predicted for esters of propylidynetrimethanol or pentaerythritol. The reaction mass of 2,2-bis(formyloxymethyl)propane-1,3-diyl diformate and formic acid is therefore not predicted to have potential to cause skin or respiratory sensitisation. The substance does not meet the criteria for classification as a skin or a respiratory sensitiser according to Regulation 1272/2008/EC.