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PBT assessment

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PBT assessment: overall result

Reference
Name:
Benzenesulfonic acid, mono-C10-13-alkyl derivs., compds. with ethanolamine (LE composition)
Type of composition:
legal entity composition of the substance
State / form:
other: Paste
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Assessed composition:MEA-LAS (LE composition)

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 a 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.

The registered substance MEA-LAS easily dissociates into MEA (cation) and LAS (anion) ions in aqueous conditions. According to the registration dossier of MEA, it was found not to be a PBT compound. 

A PBT assessment was performed for the UVCB substance itself, as well as for the constituent that would represent a worst-case for lipophilicity (C13-LAS).

1) C10-13 LAS (UVCB - Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts -(CAS No. 68411 -30 -3, EC No. 270 -115 -0)),

2) C13-LAS homologue (the most lipophilic active ingredient – typically 18.5% of C10-13 LAS) (CAS No. 26248-24 -8, EC No. 247-536-3).

Assessment of P/vP:

 

C10-13 LAS (UVCB): the substance was found to be readily biodegradable in the OECD 301B CO2 Evolution test, with 85% biodegradability in 29 days. Therefore, the substance is not persistent (section 4.1.2.1.1. of the CSR).

C13 LAS: Biodegradation kinetics in river water and sediments found to be similar to C10, C11, C12 (Larson et al., 1990).  The commercial product with C13 in it is readily biodegradable.

Conclusion on P/vP: C10-C13 LAS and C13-LAS are readily biodegradable. The experimental demonstration that all homologues of LAS are biodegradable is consistent with the understanding of the biochemistry and pathways of the LAS biodegradation process.

Assessment of B/vB:

 

The bioaccumulation potential in fish was evaluated for the C10-13 LAS (UVCB – calculated as a weighted average value), as well as for the C13-homologue.

 

Estimation of BCF based on the Tollset al. 1997; Tolls, 1998 in vivo fish studies: In a flow-through study with fathead minnows (Tolls et al. 1997; Tolls, 1998), the mixture consisted of (where C indicates the length of the carbon chain; –[number] indicates the sulfophenyl group position, and –[in] indicates the sulfophenyl group was positioned on an internal carbon): C10-2, C11-2, C12-2, C13-2, C10-in, C11-in, C12-in, C13-in, average chain-length 10.6.

The resulting lipid normalized steady-state BCFs for the individual components in the mixtures ranged from 2.8 L/kg (C10-in) to 914 L/kg (C13-2). BCFs increased with increasing alkyl chain length for a given isomer and were higher when the p-sulfophenyl moiety was positioned closer to the terminal carbon of the alkyl chain.

 

In a flow-through study with rainbow trout (Tolls et al. 2000), the mixture in the study consisted of C10 -2, C11 -2, C12 -2 and C13 -2 with an average chain-length of 10.6. Whole body BCF values ranged from 1.4 L/kg (C10-2) to 372 L/kg (C13-2) for individual components of the LAS mixture. BCFs increased with increasing alkyl chain length. 

Estimation of BCF values for the registered commercial mixture: BCF values were determined for fathead minnow and rainbow trout using the mass percent of each individual chain length in the mixture as described in the Substance Identity Profile and measured C10 to C13 LAS BCF values from above (Tolls et al. 1997, Tolls 1998, Tolls et al. 2000). Estimated mixture BCF values using 2-phenyl isomers as a conservative approach were 250 L/kg and 103 L/kg for fathead minnow and rainbow trout, respectively. These estimates and equations will be updated following the completion of a new C13 LAS bioaccumulation study currently underway.

 Species  Approach  Isomer  BCF (L/kg)
 Fathead minnow Calculation based on measured C10-2 phenyl to C13-2 phenyl BCF values, mass percent of each chain-length in the mixture   C10-13 LAS Commercial mixture 250 
 Rainbow trout Calculation based on measured C10-2 phenyl to C13-2 phenyl BCF values, mass percent of each chain-length in the mixture  C10-13 LAS Commercial mixture  103 
 Fathead minnow Measured C10-2 phenyl to C13-2 phenyl BCF values; chain-length  C13 -2  914
Rainbow trout   Measured C10-2 phenyl to C13-2 phenyl BCF values; chain-length C13 -2   372

Conclusion on B / vB properties: C10-13 LAS (UVCB) and C13 LAS are not B and not vB based on a BCF ≤ 2,000 L/kg. A final in vivo BCF test (OECD 305) with bluegill sunfish on C13 is ongoing.

 

 

Assessment of T:

None of the aquatic organisms tested in chronic test shows a NOEC <0.01 mg/l for C10-13 LAS (UVCB) or for the C13 homologue (see Table below). 

LAS is 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, LAS does not meet the PBT criteria for toxicity.

Overall conclusion: Based on the data collected and the discussion below, none of the three substances evaluated meet the criteria for either PBT or vPvB. This is justified by the fact that none of the substances meets the P or the T criteria. C10-13 LAS and C13 LAS do not qualify as B. The substances are also not classified as carcinogenic, mutagenic, or toxic for reproduction or for chronic toxicity.