Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates

PBT assessment

PBT assessment: overall result

Reference

Name:

Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates

Type of composition:

boundary composition of the substance

State / form:

liquid

Reference substance:

Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates

Reference substance:

Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates

Reference substance:

Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates

PBT status:

the substance is not PBT / vPvB

Justification:

The PBT Assessment for the substance is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (2017).

Persistence assessment

Two GLP guideline studies according to OECD 301 F and B are available investigating the ready biodegradability of the substance. In both studies the pass level was not reached within 28 days therefore the OECD criteria for being readily biodegradable were not fulfilled (0% after a prolonged test duration of 56 d in the key study). Based on these results it can be considered that the substance is potentially not mineralized under environmental conditions and thus persistency in the environment can not be excluded. Based on these two results the substance is considered to be potentially P/vP.

Bioaccumulation assessment

Based on the results of a weight of evidence approach, the test substance is regarded as not B and not vB (see document "WoE for the assessment of bioaccumulation" attached to chapter 13 IUCLID).

Toxicity assessment

According to Annex XIII of REACH Regulation (EC) No 1907/2006, a substance is considered to be toxic in terms of PBT criteria if long-term NOEC values for aquatic organisms are lower than 0.01 mg/L. In the absence of chronic toxicity data, the acute E(L) C50 values from standard toxicity test (REACH Annexes VII to X) can be used for the assessment of the T criterion. A substance is considered to potentially meet the criteria for T when an acute E(L) C50 value from a standard E(L) C50 toxicity test (REACH Annexes VII to X) is less than 0.1 mg/L. All E(L)C50 values determined in short-term toxicity with fish, daphnia and algae are above this value and the NOEC derived by the algae toxicity test above 0.01 mg/L. Hence the substance does not fulfill the screening T-criteria for the aquatic environment.

The substance is not classified as carcinogenic, mutagenic or toxic for reproduction.

Nevertheless the present information is considered insufficient for a definite conclusion on classification and labelling for sub-chronic effects. A 90 d sub-chronic study (oral) is proposed for an analogue substance. The result of this study will be used to finally assess the T criterion of this substance.