Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

Reference
Name:
Sulfuric acid, (C12-alkyl) esters, sodium salts
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Related composition:
Composition 7
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

The PBT assessment for CAS 151-21-3 is based on the criteria set out in the "Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment" (ECHA, 2008).

 

Persistence (P) Assessment:

A substance is not considered to be persistent if it can be demonstrated that it has potential to degrade (via photolysis, hydrolysis and/or biodegradation). Several studies using standardized test guidelines could demonstrate the ready biodegradability of the substance (95% after 28 days based on CO2 evolution, OECD 301 B). Therefore, CAS 151-21-3 does not meet the Persistent (P) or very Persistent (vP) criteria.

 

Bioaccumulation (B) Assessment:

The value of log Pow at 20 ºC is ≤ -2.03. Available data indicate that CAS 151-21-3 has a very low potential for bioconcentration and the substance will not accumulate to significant levels in the aquatic environment. Therefore, CAS 151-21-3 does not meet the Bioaccumulative (B) or very Bioaccumulative (vB) criteria.

 

Toxicity (T) Assessment:

Environmental Toxicity:

According to Annex XIII of REACH Regulation (EC) No 1907/2006, a substance is considered to be toxic in terms of PBT criteria if long-term NOEC values for aquatic organisms are lower than 0.01 mg/L. The NOEC value based on chronic experimental data on daphnids was 0.88 mg/L. This value exceeds the toxicity criterion and therefore, CAS 151-21-3 is not considered as a toxic substance regarding ecotoxicological endpoints.

 

Human Health Toxicity:

Carcinogenicity: the available data on CAS 151-21-3 do not warrant classification for carcinogenicity under Directive 67/548/EEC or GHS/CLP.

Mutagenicity: the available data indicate that CAS 151-21-3 is not genotoxic or mutagenic and do not warrant classification for carcinogenicity under Directive 67/548/EEC or GHS/CLP.

Reproductive Toxicity: there is no evidence that CAS 151-21-3 causes reproductive or developmental toxicity. The available data indicate that members of the alkyl sulfate category are not toxic to reproduction and do not warrant classification under Directive 67/548/EEC or GHS/CLP.

Chronic toxicity: due to the results of the relevant mammalian toxicity studies CAS 151-21-3 is not classified as Xn, R48 or STOT RE.

 

The substance is considered not to be PBT or vPvB on the basis of the provided relevant data.