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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:

Assessment of PBT/vPvB Properties

The assessment of PBT/vPvB properties has been done on the basis of the data available from the testing programme, in order to evaluate the PBT/vPvB properties of the substance. The assessment refers to the principles laid down in the “Guidance on information requirements and chemical safety assessment Parc C: PBT Assessment and Chapter 11: PBT Assessment”.

Persistent Assessment

 

The persistence assessment has been done using the following data:

Water

Ready biodegradability study: the substance is not considered ready biodegradable under the condition applied in a OECD 301D test, because it did not reach the pass level (60% biodegradation)(only 11.7 after 28 d) in the 10-day window. However the substance showed a maximum value of 11 % of biodegradation under this period, leading to consider that some initial biotic degradation started during the test.

 

Hydrolysis versus pH:

The substance is not considered to hydrolyse easily as t1/2 (pH 7): 15.8 yr at 25 °C and t1/2 (pH 9): 15.8 yr at 25 °C were predicted.

The persistence in the water compartment cannot be totally excluded on the basis of the over-mentioned criteria even if a preliminary biodegradation has been observed. Nevertheless the environmental distribution assessment shows that 1,2-dichloropropane is expected to distribute primarily in air .

No degradation products are expected as no hydrolytic behaviour has been recorded.

Based on the available data, the substance meets the criteria of Annex XIII of Regulation EC 1907/2006 for the classification as “Persistent”.

Bioaccumulation Assessment

 

The bioaccumulation assessment was performed based on the following data:

Partition Coefficient octanol/water (Pow): Log Pow values are lower than the threshold level of 4.5 as indicated in the PBT assessment guidance.

Bioaccumulation test (BCF data): The carp (fish)(freshwater) test with flow-through method for a Total uptake duration of 42 d(as for OECD Guideline 305 C, Bioaccumulation: Test for the Degree of Bioconcentration in Fish) resulted in a BCF value of 0.5 — 7.

Therefore, a direct comparison with Annex XIII criteria cannot be done with the available data, but a direct comparison is possible with screening criteria for B or vB as described in the PBT Guidance.

Based on the available data, the substance does not meet the criteria of Annex XIII of Regulation EC 1907/2006 for the classification as“Bioaccumulative”

Toxicity Assessment

 

The toxicity assessment has been performed using the following information:

a) Evidence of classification from mammalians studies: the substance is not classified as a toxic chemical;

b) Classification for carcinogenesis, mutagenesis or reproductive toxicity: the substance is not a CMR;

c) Acute eco-toxicological studies performed at the solubility levels:

- Acute toxicity in fish :        LC50= 139 mg/L

- Acute toxicity in daphnia : 48 h EC50= 2.7 mg/L

- Acute toxicity in algae: EC50 > 7.95 mg/L; NOEC = 7.95 mg/L

All acute data from eco-toxicological experimental studies are well higher than 0.01 mg/L set by the guidance and leading to a classification due to the daphnia acute study result values.

Based on the available data, the substance does not meet the criteria of Annex XIII of Regulation EC 1907/2006 for the classification as “Toxic”.

Summary and overall conclusions on PBT or vPvB properties

 

The assessment of PBT/vPvB properties has been done on the basis of the data available from the testing programme.

An overall estimation of the available data/information lead to consider that they do not allow a direct comparison with all the criteria in Annex XIII but nevertheless indicates that the substance does not have these properties on the whole.

Conclusion :

the substance is not a PBT or vPvB substance.

Emission Characterisation

Because the substance does not fulfil the PBT and vPvB criteria, no emission characterisation has been performed.