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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

The substance does not meet the criteria to be classed as a PBT or vPvB substance, based on both screening criteria and Annex XIII criteria.

Persistence Assessment:

P criteria:

– the half-life in marine water is higher than 60 days, or

– the half-life in fresh- or estuarine water is higher than 40 days, or

– the half-life in marine sediment is higher than 180 days, or

– the half-life in fresh- or estuarine water sediment is higher than 120 days, or

– the half-life in soil is higher than 120 days

No relevant half-life data is available from hydrolysis or simulation studies, Therefore the assessment of the P/vP criteria was based on the screening criteria of ready biodegradation.

The test item can be considered to be readily biodegradable under the strict terms and conditions of OECD Guideline No 301B as

it attained 82% degradation after 28 days and satisfied the 10-Day window validation criterion, whereby 60% degradation must be attained within 10 days of the degradation exceeding 10%.

Based on the screening criteria, the substance is not a P or vP substance as it is readily biodegradable.

Bioaccumulation Assessment:

B criteria: BCF > 2000.

vB criteria: BCF >5000

No experimental bioaccumulation data is available to compare against the criteria for B or vB. No experimental study is considered feasible or applicable to conduct.

Based on the initial screening criteria for B/vB (where log Kow >4.5 indicates bioaccumulation) the substance could be considered to meet either the B or vB criteria based on substance components having predicted log Kow values >4.5 . However, further assessment of the substance components indicate that bioaccumulation may not be significant for the substance components and that the B/vB criteria may not be met (refer to bioaccumulation section for full details of assessment).

Predicted BCF values for individual components were significantly below 2000 (worst case BCF 356.7), indicating that the B and vB criteria are not met.

Therefore, it may be considered that the substance does not meet the B or vB criteria.

Toxicity Assessment:

T critera:

– the long-term no-observed effect concentration (NOEC) for marine or freshwater organisms is less than 0.01 mg/l, or

– the substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2) or toxic for reproduction (category 1, 2, or 3) according to Directive 67/548/EEC or as carcinogenic (category 1A, 1B or 2), germ cell mutagenic (category 1A or 1B) or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008, or

– there is other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC or specific target organ toxicity after repeated exposure (STOT-RE category 1 or 2) according to Regulation EC No 1272/2008.

The substance has a long-term NOEC greater than 0.01 mg/l, based on the 21 day Daphnia reproduction test NOEC (immobilization and reproduction) of 320 mg/L loading rate WAF. At this loading rate there were no significant mortalities (immobilization) observed in the parental generation (P1) and that there were no significant differences (P ≥0.05) between the control and the 320 mg/L loading rate WAF test group in terms of numbers of live young produced per adult by Day 21.

The substance is not classified as carcinogenic, mutagenic or toxic for reproduction based on available study data.

The substance is not classified for chronic toxicity (either R48 or STOT RE) based on available study data.

The substance does not therefore meet the 'T' criteria.