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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:

Persistence:

The substance is readily biodegradable, the substance achieved > 60% degradation over the period of 28 days and the requirements for the 10 day window were met. The test substance is therefore not persistent.

Bioaccumulation

A QSAR was conducted using EPISuite which shows the test material to have a negative partition coefficient. This shows the test material is not likely to bioaccumulate in aquatic organisms

Toxicity:

The substance can not be considered as toxic due to the following results:

The substance has been tested at a concentration of 4040 mg/kg (this represents 2000 mg/kg active ingredient (ai)) in both the acute oral and acute dermal study. There were no effects seen in either study and due to this the LC50 values were set to > 2000 mg/kg (ai). No effects were seen when tested as an eye or skin irritant and no effects were noted when the substance was tested for skin sensitisation. No toxic related effects were seen in the 28 day study.

Three genetic toxicity studies also showed no effects these included the AMES, Chromosome aberration study and a mouse micronucleus study.

Three short term aquatic toxicity studies were conducted, no effects were seen at all in both the Fish and Daphnia studies which led to an EC50 > 1000 mg/kg ai, slight affects were seen at very high concentrations in the algal study, the ECr50 value was set to 790 mg/kg ai. This does not affect the classification of the substance in anyway and therefore the substance can be classed as not toxic.

In conclusion from the results of all the testing the substance can be classed as not classified.

The substance is not persistent in the environment, is not likely to bioaccumulate and is not toxic, therefore the test material is not a PBT substance.