Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

The PBT assessment of C8-14AS TEA (CAS 85665-45-8) 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). A study using standardized test guideline is available for C8-14AS TEA (CAS 85665-45-8) that could demonstrate the ready biodegradability of the substance (92% biodegradation after 30 days based on O2 consumption, OECD 301 D). Therefore, C8-14AS TEA (CAS 85665-45-8) does not meet the Persistent (P) or very Persistent (vP) criteria.

 

Bioaccumulation (B) Assessment:

The log Pow value was determined to be ≤ -0.76. The available data indicates that C8-14AS TEA (CAS 85665-45-8) has a very low potential for bioconcentration and the substance will not accumulate to significant levels in the aquatic environment. Therefore, C8-14AS TEA (CAS 85665-45-8) 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 0.172 mg/L. This value exceeds the toxicity criterion and therefore, C8-14AS TEA (CAS 85665-45-8) is not considered as a toxic substance regarding ecotoxicological endpoints.

Human Health Toxicity:

Carcinogenicity: the available data on C8-14AS TEA (CAS 85665-45-8) do not warrant classification for carcinogenicity under Directive 67/548/EEC or GHS/CLP.

Mutagenicity: the available data indicate that C8-14AS TEA (CAS 85665-45-8) 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 C8-14AS TEA (CAS 85665-45-8) 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, C8-14AS TEA (CAS 85665-45-8) 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.