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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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Name:
sodium cumenesulphonate
Type of composition:
boundary composition of the substance
State / form:
solid: bulk
>= 80 - <= 100 % (w/w)
Reference substance:
sodium cumenesulphonate
Reference substance:
sodium cumenesulphonate
This impurity is considered relevant for the classification and labelling of the substance
Reference substance:
sodium cumenesulphonate
This impurity is considered relevant for the classification and labelling of the substance
Name:
sodium cumenesulphonate
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Related composition:
sodium cumenesulphonate
>= 80 - <= 100 % (w/w)
Reference substance:
sodium cumenesulphonate
Reference substance:
sodium cumenesulphonate
This impurity is considered relevant for the classification and labelling of the substance
Reference substance:
sodium cumenesulphonate
This impurity is considered relevant for the classification and labelling of the substance
PBT status:
the substance is not PBT / vPvB
Justification:

Annex XIII of the REACH Regulation (1907/2006) lays down the criteria for the identification of persistent, bioaccumulative and toxic substances (PBT substances), as well as the information that must be considered for the purpose of assessing the P, B, and T properties of the substance. The criteria require that all available information is to be used, employing a weight-of-evidence approach. Substances must meet all three criteria to be considered PBT.

This substance sodium cumenesulphonate(CAS No 28348-53-0, EC No248-983-7)is from the category of hydrotropes.

Hydrotropes are not persistent (P) not bioaccumulative (B) and not toxic (T) based on standard test guideline results. 

 

 

Persistence Assessment:

 

The substance sodium cumenesulphonate is biodegradable (> 60% THCO2 within 28 days), more than 60% after 6 days. Biodegradation constitutes the primary elimination mechanism from the environment. Studies with sodium cumenesulphonate demonstrate rapid and complete biodegradation under aerobic conditions and sodium cumenesulphonate is considered to be readily biodegradable according to OECD criteria.

There is no known anaerobic biodegradation data on sodium cumenesulphonate. Due to the presence of the sulphonated aromatic group, sodium cumenesulphonate is not expected to biodegrade to a significant extent under anaerobic conditions. However, considering their ready aerobic biodegradability and their low potential for adsorption to sediment solids (log Kow), the presence of sodium cumenesulphonate in anaerobic environments is expected to be negligible.

Therefore, sodium cumenesulphonate is not persistent.

 

Bioaccumulation Assessment:

 

QSAR estimation using the BCFBAF v3.01 of the EPISUITE 4.1 indicate that the BCF of sodium cumenesulphonate is 3.16 L/kgwwt. This is well below the threshold for Bioaccumulation (B) for the PBT determination.

Fish bioconcentration studies conducted at two exposure concentrations with sodium xylenesulfonate and sodium toluene sulfonate reported BCF values of <2.3.

These experimental and estimated BCF values suggest that sodium cumenesulphonate has a low potential for bioaccumulation.

Therefore,sodium cumenesulphonateis not bioaccumulative.

 

 

 

Toxicity Assessment:

None of the long-term NOECs for marine or freshwater organisms are 0.01 mg /L.  Sodium cumenesulphonateis not classified as carcinogenic (Category 1 or 2), mutagenic (Category 1 or 2), or toxic for reproduction (Category 1, 2 or 3). There is no evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC.

Therefore sodium cumenesulphonate does not meet the PBT criteria for toxicity.

 

Summary and overall Conclusions on PBT or vPvB:

Properties Based on the data collected and the discussion above, of sodium cumenesulphonate does not meet the criteria for either PBT or VPvB as it is readily biodegraded in the environment, has a very low bioaccumulation potential, low chronic aquatic toxicity and is not classified as carcinogenic, mutagenic, or toxic for reproduction or for chronic toxicity.