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EC number: 701-284-5
CAS number: 2137881-70-8
Skin sensitisation data are available for the components.
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.
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.
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
evidence of skin sensitisation was seen in a Local Lymph Node Assaa
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.
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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