Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A modified LLNA (IMDS; OECD TG 429) was performed on 6 female NMRI mice per dose group using test substance of 0 % (vehicle control), 2 %, 10 % and 50 %. Due to the viscosity of the test item it was not possible to pipette the test item pure, which limited the maximum dose to 50 %.

Compared to vehicle treated animals, none of the parameters measured in the substance treated groups, i.e. cell counts and weights of the draining lymph nodes, ear swelling and ear weights, reached or exceeded the "positive levels" defined for this assay. Therefore, no indication for a skin sensitizing effect after administration of a concentration up to and including 50 % was seen. No indication for a non specific (irritant) activation was detected either. Overall, the concentration of 50 % turned out to be the NOEL for the parameters investigated in this study.


Justification for selection of skin sensitisation endpoint:
Only one study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

For the substance no data on respiratory sensitisation are available. Moreover, the two main components 2,2'-iminodiethanol (DEA; CAS No 111-42-2) and 2,2-bis(4-hydroxyphenyl)propane (BPA; CAS No 80-05-7) also lack of data regarding this endpoint. With respect to BPA the 2008 updated EU RAR concluded:"... based on the lack of reports of cases of respiratory sensitisation, there are no grounds for concern for this endpoint."

Justification for classification or non-classification

According to Regulation (EC) No 1272/2008, Annex I, no classification is warranted for skin sensitisation.

The highest concentration tested in an LLNA with negative outcome was 50 % due to the viscosity of the test item, which did not allow to pipette the test item pure. Although the NOEL of the study for the sensitisation parameters was therefore 50 %, it is not expected that higher concentrations would have a sensitising potential. This is supported by the data for two of the components of the substance: 2,2'-iminodiethanol (DEA; CAS No 111-42-2) was not sensitizing, when tested in a GPMT (cp. OECD SIDS 2007), and for 2,2-bis(4-hydroxyphenyl)propane (BPA; CAS No 80-05-7), although being legally classified as Skin Sens. 1, the available LLNAs on skin sensitisation do not support a sensitising potential (Bayer AG, 2002 and 2003, see ECHA disseminated data). The 2008 updated EU RAR concluded with respect to these LLNAs that they "does not confirm the previously reported evidence of a skin sensitising potential of BPA."

Additionally, the two other main components of the substance (Mannich Bases 1 and 2) revealed no protein binding alert for skin sensitization in QSAR analysis (OECD Toolbox, version 3.3.0.132).

Summarizing, the available data neither reveal an indication for a skin sensitizing potential for the substance itself nor for constituents of the substance and therefore classification for skin sensitisation is not warranted.