Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

The reaction mass of phenol and 4,4'-isopropylidenediphenol (BPA) contains phenol and BPA.

For considerations on the analogue approach used please refer to the reporting form attached to section 13 of the IUCLID.

PHENOL:

In the EU-RAR on phenol (2006; Section 4.1.2.5, page 88) it was concluded that phenol did not cause any signs of skin sensitisation in the tests conducted.  

In a modified Buehler test in guinea pigs (Itoh, 1982) no skin sensitization was detected after repeated dermal exposure to phenol. In accord, the results in a mouse ear swelling test suggested no sensitizing properties of phenol (Descotes, 1988).

BPA:

The 2003 EU RAR on BPA concluded that based on the findings from the most robust animal study, BPA may possess a skin sensitisation potential, albeit a limited one, and that the available data suggest that BPA is considered capable of producing skin sensitisation responses in humans.

The 2008 updated EU RAR concluded: "Overall the new information does not confirm the previously reported evidence of a skin sensitisation potential of BPA. While the data do not exclude a skin sensitising activity of BPA at high concentrations (>30%), there is no evidence that this is a concern for workers in current BPA manufacturing plants (such workers are believed to represent the group most likely to be exposed to BPA in dust)."

There is no significant new information on the skin sensitisation of BPA that was not discussed in the 2003 or 2008 EU RARs.


Migrated from Short description of key information:
The reaction mass of phenol and 4,4'-isopropylidenediphenol (BPA) contains phenol and BPA. Phenol did not cause skin sensitisation in a modified Buehler test and in a mouse ear swelling test. Sensitisation studies on BPA led to mainly negative results, but as BPA has been assigned an official classification with R43 according to DSD, this classification will also be assigned to the reaction mass for the time being.

Respiratory sensitisation

Endpoint conclusion
Additional information:

The 2003 EU RAR concluded that there are no data from which to evaluate the potential of BPA to be a respiratory sensitiser.

The 2008 updated EU RAR concluded the same thing, but added: "However, based on the lack of reports of cases of respiratory sensitisation, there are no grounds for concern for this endpoint."

There is no significant new information on the respiratory sensitisation of BPA that was not discussed in the 2003 or 2008 EU RARs.


Migrated from Short description of key information:
No information available

Justification for classification or non-classification

The reaction mass will be classified as R43 according to DSD and Skin Sens 1 according to CLP based on its content in BPA, which is, despite the contrary conclusion of the EU RAR, classified R43 according to Annex 1 of Regulation 67/548/EEC and Skin Sens. 1 according to Annex VI of Regulation (EC) No 1272/2008.