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:

Results from the LLNA study OECD 429 and from various OECD 406 studies on BPS do not show skin sensitizing potential on pigs and mice tested.1 2 3

No data are available on the salified phenol sulfonic acid, benzenesulfonic acid, 4-hydroxy-, sodium salt (1:1), CAS 825-90-1.4

Data on salified sulphonated phenols (similar substances called hydrotropes), can be considered.

A category approach evaluation is available on sodium xylenesulphonate. The estimated irritant property of this substance can be helpful (in read across as well) to understand the irritant property of sodium sulphonated phenols, part of the intermediate DCB 58%.

Sodium xylenesulphonate is a non skin sensitizer.5 

References:

1ECHA Registration Dossier CAS 80-09-1;

2SIDS INITIAL ASSESSMENT PROFILE, CAS 80-09-1, CoCAM 4, 16-18 April 2013;

3EPA, U.S. Environmental Protection Agency, Bisphenol A alternatives in thermal paper, Final Report, January 2014.

4HPV Assessment Report On Hydroxybenzenesulphonic acid CAS No. 1333-39-7, 2004, NOTOX.

5ECHA Registration Dossier, Sodium xylenesulphonate, CAS 1300 -72 -7.


Migrated from Short description of key information:
Skin: non sensitizer

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin sensitization

In order to classify the whole mixture for the skin sensitization, the available classification and the results of the reported studies of every known component has been taken into account.

4,4'-sulfonyldiphenol (BPS): non classified

Benzenesulfonic acid, 4-hydroxy-, sodium salt (1:1)- hydrotropes, sodium xylenesulphonate (category approach): non classified

2,4'-sulfonyldiphenol: non classified (C&L ECHA Inventory).

phenol: non classified.

Approximately 48% of the organic part of the intermediate under registration is composed of BPS.

Approximately 14% of the organic part of the mixture is the salified form of the phenol sulfonic acid (p-APS), benzenesulfonic acid, 4-hydroxy-, sodium salt (1:1).

Actually, this substance is completely salified, and therefore, a category approach based on the hydrotropes should be taken into account for a more realistic classification of the whole intermediate mixture DCB, that it is in the neutralized form.

2,4'-sulfonyldiphenol is present at 6%, but it is not considered sensitizer.

Phenol is present at concentration of 1.8% (for the evaluation of the skin sensitization potential the presence between 0.01% to 1% shall be taken into account), but it is not classified.

According to the CLP Regulation 1272/2008/EC, 3.4 section, point 3.4.3.3, Table 3.4.5, generic concentration limits shall be used to determine if the mixture is considered to be a non skin sensitizer.

Based on the information available, the intermediate DCB 58% is not classified as a skin sensitizer.