Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Bisphenol F Diglycidylether (BPFDGE) was positive for the induction of dermal sensitization in the mouse Local Lymph Node Assay (LLNA). Based on an EC3 value of 0.7% BPFDGE is considered to be a strong dermal sensitizer. Following ECHA guidance this EC3 value is converted to an EC3 value of 175 ug/cm2 and is considered the LOAEL for the induction of dermal sensitization the mouse LLNA for BPFDGE. 

In 2 guinea pig maximization test of Magnusson and Kligman 75-100% of the test animals showed positive responses at 24 and 48 hours after removal of the challenge patches. From this GLP sensitization test it can be concluded that BPFDGE is a sensitizer. The Buehler method was employed to evaluate the dermal sensitization potential of DER 354. 80% had a positive response and under the conditions of this study, the test material caused delayed hypersensitivity in guinea pigs.

For acute toxicity there are multiple studies for skin sensitization that have been performed with the substance described as “formaldehyde, oligomeric reaction products with 1-chloro-2,3-epoxypropane and phenol (CAS# 9003-36-5). Depending on the conditions of the reaction, the formation products can results oligomers up to the polymer molecular weight range and structure. Two of these substances are DEN 438 and EPIKOTE 155.

In the guinea pig maximization tests of Magnusson and Kligman the DEN 438 test material produced a 15% sensitization rate (3 of 20 animals) and was classified as a mild sensitizer to guinea pig skin and the EPIKOTE 155 had no sensitization response. The higher molecular weight range material has less sensitization potential, however, because the low molecular weight moieties can have a high sensitization potential the substance described as “formaldehyde, oligomeric reaction products with 1-chloro-2,3-epoxypropane and phenol (CAS# 9003-36-5) is classified as a skin sensitizer.


Migrated from Short description of key information:
From the six sensitization tests it can be concluded that BPFDGE is a sensitizer.

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
No data

Justification for classification or non-classification