Registration Dossier
Registration Dossier
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EC number: 235-849-8 | CAS number: 13007-85-7
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistance:
The substance is not persistent in the environment as the test material was found to be readily biodegradable in water. The 28 day ready biodegradation study showed the test material achieved > 60% degradation after 28 days and the criteria regarding the 10 day window was met.
Bioaccumulation:
The Log Kow has been calculated as negative, it is therefore unlikely that the test material will bioaccumulate in the environment.
Toxicity:
The test material is not toxic due to the following:
The test material has been tested via the two most appropriate routes of exposure (oral and dermal routes). Testing via the inhalation route is not applicable as only 4.98% of the test material has a particle size of < 100 µm. The vapour pressure is also very low. The LC50 values for both the acute oral and acute dermal study was set to > 2000 mg/kg.
The substance was not classed as a skin or eye irritant and is not a sensitiser to the skin. An AMES study has been conducted and confirms the test material is not mutagenic.
Additional information is available on the surrogate material. The surrogate material has been investigated using the studies listed above, however the following additional data is also available:
A Chromosome aberration study and a mouse micronucleus study also suggests the test material is not mutagenic.
Three short term aquatic toxicity studies were conducted, no effects were seen at all in both the Fish and Daphnia studies and therefore the EC50 value was determined to be > 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 the results above show the test material to be not toxic. The test material is not classified in respect to human health or towards the environment.
In conclusion for the test material to be considered a PBT substance, all three criteria (Persistance, bioaccumulation and toxicity) must be met. In this case none of the three criteria are met and therefore the test material is not considered to be a PBT substance.
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