3β-hydroxyandrost-5-en-17-one acetate

PBT assessment

PBT assessment: overall result

Reference

Name:

T008506

Type of composition:

legal entity composition of the substance

State / form:

solid: particulate/powder

Related composition:

T008506

Reference substance:

T008506

PBT status:

the substance is not PBT / vPvB

Justification:

Persistency assessment

The persistency assessment is based on the screening criteria in Annex XIII of the REACH Regulation. The biodegradation potential of the test substance has been assessed in a OECD 301B study (Timmer, 2017). The results reveal that the test substance degrades and the substance is considered to be readily biodegradable. It can therefore be concluded that based on the criteria mentioned above the substance is not persistent in the environment. The substance is concluded to be not P/vP.

Bioaccumulation assessment

Based on the OECD 117 guideline study (Ciric, 2017), the Log Kow of the test item was determined to be 5.1 at neutral pH. This value is slightly higher than the threshold value of log Kow ≤ 4.5. Considering the extremely low water solubility value of T008506, the rapid environmental biodegradation and the influence of lipid solubility on the bioconcentration of hydrophobic substances such as T008506, it can be assumed that bioaccumulation in aquatic organisms is not expected.

This is supported by BCF values <2000 L/kg (BCFBAF v3.01, Arnot-Gobas, including biotransformation). However a conservative approach was followed and the substance was classified as potentially B/vB.

Toxicity assessment

The toxicity assessment is based on the screening criteria in Annex XIII of the REACH Regulation. A substance fulfils the toxicity criterion (T) when:

- the long term no observed effect concentration (NOEC) for marine or freshwater organisms is less than 0.01 mg/L.

- the substance is classified as carcinogenic (category 1A or 1B), mutagenic (category 1A or 1B) or toxic for reproduction (category 1A, 1B or 2); or

- there is other evidence of chronic toxicity, as defined by the classifications STOT (repeated exposure), category 1 (oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) or category 2 (oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume, according to Regulation (EC) No 1272/2008.

The available aquatic toxicity data for fish, invertebrates and algae show that T008506 does not meet the Annex XIII T criteria based on the available data on its toxicity to pelagic organisms. Based on an OECD 201 study (Tobor-Kaplon, 2017) it is concluded that the test item does not meet the Toxic (T) criteria since the EC10 and NOEC values were > 0.32 and ≥ 0.32 mg/L respectively. The test substance however is classified as reproductive toxicant Cat. 1B, hence the substance is concluded to fulfill one of the "T" criteria.

It can be concluded that based on the criteria mentioned above the substance fulfills the "T" and "B" criteria but not the "P" criteria, therefore the substance is not a PBT nor a vP/vB substance.