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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB

PBT/vPvB criteria and justification

Persistence (P) Assessment:

According to the screening criteria for PBT a substance is not considered to be persistent if it can be demonstrated that it is readily biodegradable but failing the 10 -day window. The Information requirements technical guidance R11, states that if a substance does not meet the criteria for a readily biodegradable substance then it is considered potentially Persistent or Very Persistent (P/vP) and more data is required to make a classification. R11 also reports that if a substance meets the criteria of 60%/70% degradation in an extended ready biodegradation test (no more than 60 days) then it can be shown that the substance is not persistent in the environment and the designation of P/vP does not apply.

The key study for P1400 is an OECD 310: Ready Biodegradability – CO2 in sealed vessels (Headspace Test) performed in 2019. During this study P1400 attained a mean level of biodegradation (based on % ThIC) of 82% at 60 days, and the results showed good replication. Less than 60% degradation was achieved within the 10-day window, so P1400 is classified as readily biodegradable but failing the 10 -day window.

In a second key study the biodegradability of P1400 was investigated in accordance with OECD 301F. Averages of the percentage biodegradation of the test item by BOD were 91% on Day 28, and 52% at the end of the 10-day window. The results showed that the test item can be considered readily biodegradable, but failing the 10-day window. The test item can be assumed not to be inhibitory on the activated sludge microorganism at the applied concentration level of 100 mg/L.

As such, Santicizer Platinum P1400 is by default not Persistent (P) and/or very Persistent (vP).

Bioaccumulation (B) Assessment:

According to the screening criteria for PBT substances with a log Kow of >4.5 cannot be screened out as not bioaccumulative (B) and/or very bioaccumulative (vB). As the calculated log Kow of Santicizer Platinum P1400 is 4.56 the bioaccumulation endpoint cannot be waived. However, ECHA's Guidance on Information Requirements and Chemical Safety Assessment R7c Endpoint Specific Guidance (2008) indicates that before commissioning a new vertebrate test alternative sources of data on the bioaccumulation potential of a chemical should be used. As such, the R11 Information Requirements specify that further data on bioaccumulation is not required to be generated.

A Bioconcentration Factor (BCF) of 1439 L/kg (log BCF of 3.158) was calculated using this the QSAR in Episuite v 4.11.

P1400 is therefore not Bioaccumulative (B) and/or very Bioaccumulative (vB).

Toxicity (T) Assessment:

As P1400 is not P/vP or B/vB a toxicity assessment is not required. However, P1400 is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), toxic for reproduction (category 1A, 1B, or 2) or specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008. The data on ecotoxicity shows that P1400 is non-toxic to aquatic organisms following log-term exposure at the limit of water solubility. Therefore does not have a long-term no-observed effect concentration (NOEC) or EC10 for marine or freshwater organisms of less than 0,01 mg/l.

P1400 does not meet the criteria for Toxicity (T).

Conclusion of PBT/vPvB assessment

The available data showed that P1400 is not P/vP, B/vB and not T.