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Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB

The PBT Assessment forethyl 3,5-dichloro-4-hexadecyloxycarbonyloxybenzoateis based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).

Persistence (P/vP) Assessment:

Based on the results in an enhanced ready biodegradability test according to OECD Guideline 301 B and GLP, the target compound is considered as ultimately biodegradable (67% biodegradation in 60 days). Therefore, based on a screening test, the compound does not met the P/vP criterion.

Bioaccumulation assessment (B/vB):

As there is no experimental data available evaluating the bioaccumulation of ethyl 3,5-dichloro-4-hexadecyloxycarbonyloxybenzoate, a scientifically accepted calculation method was used for further assessment (BCFBAF v3.01, EPISuite™ (US EPA)). The estimated BCF (11.5-251 L/kg ww) and BAF (1878 L/kg ww) values indicate that AF-366 shows potential for bioaccumulation in aquatic organisms. However, the criterion for bioaccumulation according to Annex XIII of the REACH Regulation (1907/2006/EC) (BCF >= 2000 L/kg) was not met with the model calculations. Therefore, the target substance is not considered as bioaccumulative.

Toxicity assessment (T):

No adverse effects were observed in acute aquatic studies up to a nominal concentration of 100 mg/L on the three trophic levels, fish, daphnia, and algae. The target substance did not cause any adverse effects on fish survival (LC50 > 100 mg/L, nominal) or aquatic invertebrates mobility (EC50 > 100 mg/L, nominal) after 96 and 24 hours, respectively. The results from the algae study showed a slight increase in biomass and growth rate in the treatment replicates compared to controls (72h-EC50 >100 mg/L, nominal; NOEC >= 100 mg/L, nominal). Based on the available information, the substance is considered to be not toxic to aquatic organisms within the range of its water solubility (≤ 0.078 mg/L), all acute and chronic effects were > 0.01 mg/L.Moreover,3,5-dichloro-4-hexadecyloxycarbonyloxybenzoateis not classified as carcinogenic, mutagenic, toxic for reproduction, germ cell mutagenic or toxic for reproduction and does not bear specific target organ toxicity after repeated exposure according to the consolidated version of Regulation (EC) No. 1272/2008 (and further ATPs). Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the test substance is not considered to meet the T-criterion.

Overall conclusion:

Based on the assessment described in the subsections above the submission substance is not a PBT / vPvB substance.


According to Annex XIII of the REACH Regulation (EC) No 1907/2006, a PBT substance has to meet all three of the criteria for persistence, bioaccumulation and toxicity, as listed in part 1 of Annex XIII, and a vPvB substance has to meet all criteria for persistence and bioaccumulation, as listed in part 2 of Annex XIII. Based on the relevant data provided and discussed, the substance is not identified as PBT or as a vPvB substance.

Likely routes of exposure: