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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

The target substance 2 -decyltetradecanoic acid was demonstrated to be readily biodegradable but failing the 10 -day-window in an OECD guideline 301 B-test.

Therefore the substance is not considered to be persistent (P).

All Category members including 2 -decyltetradecanoic acid have calculated BCF of 3.162, meaning the BCF, meaning the BCF << 2000, therefore the substances are considered not to be bioaccumulative according to the PBT-criteria.

Toxicity Aquatic toxicity tests do not indicate that any of the Category members including 2 -decyltetradecanoic acid meets the criteria to be regarded as toxic (T).

The short-term toxicity of the source substance 1, Reaction mass of n-undecanoic-acid and 2-methyl-decanoic-acid and 2-ethyl-nonanoic-acid and 2-propyl-octanoic-acid and 2-butyl-heptanoic-acid, was assessed in two main trophic levels of fresh water organisms (invertebrates and algae). For Daphnia, a 48h-EC50 of 16 mg/l (95% confidence interval between 13 and 19 mg/l) was obtained. In a study with a fresh water algae, the source substance 1, Reaction mass of n-undecanoic-acid and 2-methyl-decanoic-acid and 2-ethyl-nonanoic-acid and 2-propyl-octanoic-acid and 2-butyl-heptanoic-acid inhibited growth rate and yield significantly at a time weighted average concentration of 4.2 mg/L and higher, resulting in an NOErC (72h) of 1.3 mg/L. The EC50 for growth rate inhibition (72h-ErC50) was 13 mg/L (95% confidence interval ranging from 11 to 15 mg/l). The estimated ErC10 (72h) was 2.7 mg/L (95% confidence interval between 2.0 and 3.5 mg/l). In a short term toxicity study to invertebrates with the Category member 2, 2 -butyloctanoic acid, the 48h-EC50 to Daphnia magna was found to be 31 mg/l (95% confidence interval between 22 and 42 mg/l). The Category member 3, 2 -decyltetradecanoic acid, showed no toxicity in the range of water solubility.

Furthermore all Category members including 2 -decyltetradecanoic acid are not classified as carcinogenic, germ cell mutagenic, or toxic for reproduction or STOT.

Hence the substance does not meet the criteria to be regarded as a PBT or vPvB substance.

An emission characterisation for 2 -decyltetradecanoic acid is not needed because it is not a PBT.