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PBT assessment

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PBT assessment: overall result

Reference
Name:
2,2-bis[[3-(dodecylthio)-1-oxopropoxy]methyl]propane-1,3-diyl bis[3-(dodecylthio)propionate]
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

The substance does not screen as PBT or vPvB on the following basis:

“P”

Ready biodegradability was assessed using the carbon dioxide (CO2) evolution test (modified Sturm test). The relative biodegradation values calculated from the measurements performed during the test period revealed no significant biodegradation of the test substance (4% and 6%, based on ThCO2). In conclusion, the substance was designated as not readily biodegradable.

“B”

 

The substance was tested within a bioaccumulation study. The mean concentration of the test substance in test solution during 28 days of the exposure period was 0.200 mg/L for the first concentration level and 0.0182 mg/L for the second concentration level, and these were sufficiently close to the nominal values. The test substance concentration in test fish was < 1.27 μg/g for the first concentration level and < 1.50 μg/g for the second concentration level. The bioconcentration factor (BCF) was < 7 folds for the first concentration level and < 84 folds for the second concentration level. Based on above results, it is considered that the bioaccumulation level of the test substance in fish is low.

“T”

The substance is highly insoluble in water. In consequence exposure to three aquatic species (algae, daphnia and fish) have been investigated at nominal concentrations. The toxicological examination of freshwater fish, daphnia and algae provided the following results:

LC50 > 100 mg/l WAF in fish

EC50 > 100 mg/l WAF in daphnia

EC50 > 100 mg/l WAF in algae

The substance is not classified on the basis of these results and no further toxicological examination is considered appropriate to determine that hazard of the substance.

The substance has been assessed for genetic toxicity utilising in vitro assays with and without metabolic activation. All endpoints demonstrated a lack of mutagenic response. The reproduction/developmental screening test provided a result NOAEL 1000 mg/kg bw/day for reproduction effects.

The NOAEL for Systemic toxicity in adult rats was considered to be 60 mg/kg bw/day in an OECD 422 study. The substance therefore screens as “T” on this basis.