Reaction mass of 4,4'-isopropylidenediphenol and phenol

Endpoint summary

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 as Skin Sens. 1 according to Annex VI of Regulation (EC) No 1272/2008

 

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation, other

Remarks:

LLNA, non-LLNA

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that the properties of the target substance Reaction mass of phenol and 4,4’-isopropylidenediphenol can be predicted by studies conducted with the source substances phenol, 4,4’-isopropylidenediphenol (BPA), and 2-acetone, polymer with phenol, because the target substance Reaction mass of phenol and 4,4’-isopropylidenediphenol contains phenol (40-45%, typical concentration ca. 40%) and 4,4’-isopropylidenediphenol (BPA) (20-40%, typical concentration ca. 33%) as main constituents. Both constituents are data rich substances with distinct hazard properties, so that mainly data on the constituents have been applied to characterize the Reaction mass of phenol and 4,4’-isopropylidenediphenol. Since this is a common approach in mixture hazard assessment, is reasonable to apply it also to multi-constituent substances.
Additionally, some data from a structurally related substance (2-acetone, polymer with phenol) containing the same constituents/impurities at different concentrations are available, which are applied to characterize the environmental fate and ecotoxicity of the impurities present in the Reaction mass of phenol and 4,4’-isopropylidenediphenol.

This read-across hypothesis corresponds to scenario 2 - different compounds have qualitatively and quantitatively the same type of effects - of the read-across assessment framework i.e. properties of the target substance Reaction mass of phenol and 4,4’-isopropylidenediphenol are predicted to be similar to those of the source substances phenol, 4,4’-isopropylidenediphenol (BPA), and 2-acetone, polymer with phenol.

Therefore, read-across from the available studies with the source substances is considered as an appropriate adaptation to the standard information requirements of the REACH Regulation for the target substance Reaction mass of phenol and 4,4’-isopropylidenediphenol, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.


2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
please refer to justification for read-across attached to Iuclid section 13

3. ANALOGUE APPROACH JUSTIFICATION
please refer to justification for read-across attached to Iuclid section 13

4. DATA MATRIX
please refer to justification for read-across attached to Iuclid section 13

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reading:

1st reading

Group:

test chemical

Remarks on result:

no indication of skin sensitisation

Remarks:

Phenol

Parameter:

EC3

Test group / Remarks:

BPA

Remarks on result:

other: not sensitising in LLNA and photoreactive LLNA; however, harmonised classification as Skin Sens 1

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

Conclusions:

No experimental data are available for the target substance Reaction mass of phenol and 4,4’-isopropylidenediphenol. However, based on the general principles of mixture toxicology, data on the main constituents of this multi-constituent substance are used as surrogate. Due to the legal classification of BPA as Skin Sens 1 the target substance Reaction mass of phenol and 4,4’-isopropylidenediphenol is classified as skin sensitiser (Cat 1).

Endpoint conclusion

Additional information:

No experimental data are available for the target substance Reaction mass of phenol and 4,4’-isopropylidenediphenol. However, based on the general principles of mixture toxicology, data on the main constituents of this multi-constituent substance are used as surrogate. A justification for read-across is attached to Iuclid section 13.

 

Data on 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).

 

Data on 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.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

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, 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.

 

Justification for classification or non-classification

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