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PBT assessment

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PBT assessment: overall result

Reference
Name:
418-310-3
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Persistence

The test item attained 1% 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 a prediction for bioaccumulation was concluded based on QSAR data.

The prediction of the potential for bioaccumulation of HP-10 was performed with VEGA NIC 1.1.4 (CAESAR, Meylan, KNN), ToxRead 0.11beta, BCFBAF 3.01 (EpiSuite) and US EPA T.E.S.T. 4.2.

Please see table below for Bioaccumulation results:

Model

Log BCF [L/kg]

Log Kow

Reliability

US EPA TEST

3.35

-

Low

CAESAR (VEGA)

1.12

7.69

Low

Meylan (VEGA)

1.09

13.2

Low

KNN/Read-Across (VEGA)

2.04

-

Low

BCFBAF (EPI Suite)

0.5

15.43

Low

ToxRead

2.06

13.2

Low

 

There is uncertainty in all predictions and therefore confidence in the results is also low. However, with five out of six models predicting BCFs less than 2000 L/kg there is an argument for a weight of evidence that HP-10 is likely to be not bioaccumulative.

Please refer to section 5.3.1 for all Bioaccumulation robust study summaries.

A bioaccumulation study was conducted on HP-10 however the study is scored as reliabilty 3. Therefore this study cannot be used to confirm the Bioaccumulation however the study can be used as supporting data in addition to the QSAR results.

This study also indicates that HP-10 is not bioaccumulating.

For Bioaccumulation it can be concluded the substance is not Bioaccumulating based on the available data.

Toxicity

No long term aquatic toxicity data are available however no toxicity 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 and in-vivo studies were concluded negative. In the reproductive toxicity screening study no reproductive effects were seen and no development effects were seen. 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 or a vPvB substance.