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PBT assessment

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PBT assessment: overall result

Reference
Name:
Registrant composition
Type of composition:
legal entity composition of the substance
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Persistence

The test item attained 0% biodegradation after 28 days and therefore cannot be considered to be readily biodegradable. The substance was found not to be readily biodegradable and hydroylsis testing was not feasible on the basis of poor water solubility. In the absence of any data to the contrary it must be assumed the substance possesses P or vP properties.

 

Bioaccumulation

The screening criteria indicates the substance may be bioaccumulative or very bioaccumulative based on the Log Kow value which is >6.2 however the test substance has a very high molecular weight and no higher tier studies are available (ie experimental bioaccumulation testing) therefore insuffcient data are available to permit a definitive conclusion.

According to the ECHA guidance Chapter R.7c and R.11: endpoint specific guidance it suggests that substance which have a high molecular weight above 700 are an indicator for considering that the substance is not a vB substance. High molecular weight substances can either be too lipophilic or too hydrophilic to pass through membranes making it very difficult for the test item to be absorbed into the skin. The test item LA-63P is a UVCB substance which is made up of 4 components, 3 out of the 4 components have a molecular weight >1000 and the lowest molecular weight component has a molecular weight of 980.

Also according to the Arnot and Gobas model (2006) ionic substances with a Log Kow >7 show a decrease in Log BCF value which leads to a decrease in bioaccumulation. The test item has a Log Kow >6.2. with the possibility of being >7.

For Bioaccumulation no conclusion can be reached based on the available data.

Toxicity

No long term aquatic toxicity data are available however no toxcity was seen at any trophic level during acute aquatic toxicity testing. There are no data available to assess carcinogenicity. For mutagenic effects all in-vitro studies were concluded negative. In the reproductive toxicity screening study no reproductive effects were seen and no development effects were seen in the absence of possible toxic effects seen in maternal animals. There was no evidence of any significant organ damage during the 28day repeat dose oral study .

Based on the data above the substance does not meet criteria for T properties.

 

Overall it is concluded that the substance is not a PBT substance.