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PBT assessment

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PBT assessment: overall result

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Name:
Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-, C12-13-branched alkyl esters
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-, C12-13-branched alkyl esters
Reference substance:
Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-, C12-13-branched alkyl esters
Reference substance:
Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-, C12-13-branched alkyl esters
PBT status:
the substance is not PBT / vPvB
Justification:

The biodegradability of Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-, C12-13-branched alkyl esters was assessed in a CO2 -evolution test according to the OECD 301B guideline (July 1992). The degradation extent of the test item was 64.2 % within 35 days after acidification. The degradation after 28 days was 54.0%. According to the Revised Introduction to the OECD Guidelines for Testing of Chemicals, Section 3 the test item can be classified as inherently biodegradable.

The BCFBAF version 3.01 programme of the EPI Suite software (v 4.10) was used to predict either a log BCF of 2.19 (BCF of 153 L/kg wet-wt) (linear C12 -component), 2.26 (BCF 181 L/kg wet-wet) (branched C12 -component), 1.78 (BCF 59.7 L/kg wet-wt) based on a regression estimate or a log BAF of - 0.01 (BAF of 0.966 L/kg wet-wt) (linear C12 -component), log BAF -0.01 (BAF = 0.972 L/kg wet-wt) (C12 -branched component), log BAF -0.04 (BAF = 0.91 L/kg wet-wt) (C13 -branched component) based on the Arnot-Gobas upper trophic model both usingthe smiles codes of Butanedioic acid, 2,3 -dihydroxy-[R-(R*,R*)]-C12 -linear alkyl esters, Butanedioic acid, 2,3 -dihydroxy-[R-(R*,R*)]-C12 -branched alkyl esters and Butanedioic acid, 2,3 -dihydroxy-[R-(R*,R*)]-C13 -branched alkyl ester representing Butanedioic acid, 2,3 -dihydroxy-[R-(R*,R*)]-C12 -13 -branched alkyl ester. Because the Arnot-Gobas upper trophic model takes also into account metabolism of the substance by the organism it is lower. The QSAR-data are supported by the results of the pharmacokinetics. Butanedioic acid, 2,3 -dihydroxy-[R-(R*,R*)]-C12 -13 -branched alkyl esters will be hydrolysed, absorbed and efficiently metabolised into water soluble metabolites, which is supported by the molecular structure of Butanedioic acid, 2,3 -dihydroxy-[R-(R*,R*)]-C12 -13 -branched alkyl esters and its physico-chemical properties.

It is concluded that Butanedioic acid, 2,3 -dihydroxy-[R-(R*,R*)]-C12 -13 -branched alkyl esters will not accumulate in the body.

A group of 20 Brachydanio rerio was used, of which 10 were treated with the similar substance Butanedioic acid, 2,3-dihydroxy-di-C14-C15 alkyl esters at a concentration (100 mg/L dispersion concentration) exceeding the solubility of the substance, 10 were used as a control, kept in the same conditions without adding the test material. During the study no toxic symptoms or mortality were observed in the treated and the control group. The LC50 was > 100 mg/L. It is likely that the test substance has similar toxicological properties.

An acute immobilisation test with Daphnia magna (STRAUS) was conducted with the test item according to OECD 202. According to the results of the test, the EL50 (48 h) for immobilisation was supposed to be > 100 mg/L (nominal). The corresponding NOELR (48 h) was 20.7 mg/L (nominal).

No statistically significant inhibitory effects on any parameter (growth rate, yield) were observed at any of the test item loading rates in an algae test, including the highest test item loading rate of 100 mg/L (nominal) at test end. Thus the overall LOELR was not determinable and the overall NOELR was observed to be at 100 mg/L (nominal).

The EL10-, EL20- and EL50-value for growth rate (ErL10, 20, 50) and the EL10-, EL20- and EL50-value for yield (EyL10, 20, 50) were > 100 mg/L (nominal).