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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 substance is readily biodegradable. The test material, zinc 3,5-bis(α-methylbenzyl)salicylate, attained 84% degradation after 28 days and therefore can be considered as readily biodegradable under the strict terms and conditions of the OECD Guidelines. The study was continued for a further 7 days after which time the test material had attained 94% degradation. Therefore, the substance is not considered to be persistent.

The log Kow of the substance is < 3 therefore it is not considered to be bioaccumulative.

Two long term aquatic toxicity studies are available for two relevant trophic levels, algae and aquatic invertebrates. The 72h NOEC for algae is 1.6 mg/L and the 21d NOEC for Daphnia is 0.32 mg/L. Both these values are > 0.01 mg/L.

The substance is not classified as either carcinogenic, mutagenic or toxic for reproduction.

There was no evidence of specific target organ toxicity in the two repeated dose toxicity studies therefore the substance is not classified as either STOT RE 1 or as STOT RE 2.

In summary, the substance does not fulfil the requirements of Annex XIII, Para 1.3 based on evaluation of available data, and cannot be considered as “T” for the purposes of the assessment.

Summary and overall Conclusions on PBT or vPvB Properties

The substance cannot be considered to fulfil all the criteria for Persistence, Toxicity or Bioaccumulation, as specified in REACH Annex XIII. As such, the substance cannot be considered a PBT or vPvB substance, based on the available data.