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PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Imwitor 375 is not a PBT/vPvB substance based on the reliable laboratory testing information available.

Persistence (P)

A reliable ready biodegradability study for the read-across substance Imwitor 372 is available and demonstrated ready biodegradability over a 28-day period according to OECD test guideline 301D. The test substance was degraded by 68 % after 28 days of incubation with the 10-day window being waived for UVCB substances. The argumentations for the read-across from Imwitor 372 (source) to Imwitor 375 (target) are presented in the assessment report 'Read-across justification from Imwtor 372 (CAS 91744-38-9), castor oil (CAS 8001-79-4), medium chain triglycerides (CAS 73398-61-5) to Imwitor 375 (CAS 91744-23-9)' in section 13. Imwitor 375 is classified as readily biodegradable and it is concluded that the substance is not persistent (not P or vP).

Bioaccumulation (B)

No studies are available for bioaccumulation and this endpoint is not a requirement for Annex IX of the REACH Regulation. However, published information is available on the read-across substance Medium chain glycerides (CAS 73398-61-5) supported by the read-across justification report in section 13 of this CSR. In summary, due to the properties of the category members Fatty Acid Glycerides, their bioaccumulation in aquatic organisms is assumed to be low. As Fatty Acid Glycerides are readily biodegradable and have very low water solubility (< 1 mg/L), only low concentrations in the aquatic environment and thus a low exposure of aquatic organisms can be expected. Therefore, the substance does not meet the B and vB criteria.

Toxicity (T)

Imwitor 375 does not display toxic effects at the maximum loading rate of 100 mg/L WAF in a long-term algae study or in short-term aquatic ecotoxicity studies conducted at three trophic levels. In addition, Imwitor 375 is not classified as toxic to human health. Therefore, it is concluded that Imwitor 375 is not toxic (not T).