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PBT assessment

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PBT assessment: overall result

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Name:
Santicizer 278®
Type of composition:
legal entity composition of the substance
State / form:
other: Oily liquid
Related composition:
Santicizer 278®
Reference substance:
Santicizer 278®
Reference substance:
Santicizer 278®
Reference substance:
Santicizer 278®
Reference substance:
Santicizer 278®
Name:
Santicizer 278®
Type of composition:
boundary composition of the substance
State / form:
other: Oily Liquid
Reference substance:
Santicizer 278®
Reference substance:
Santicizer 278®
Reference substance:
Santicizer 278®
Reference substance:
Santicizer 278®
PBT status:
the substance is not PBT / vPvB
Justification:

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 has potential to degrade (via photolysis, hydrolysis and/or biodegradation).

The ready biodegradability of the Santicizer® 278 was determined in a 28-day biodegradation study performed in accordance with OECD 301B. The test item is readily biodegradable under the strict terms and conditions of the test.

As such, Sancticizer® 278 is by default considered 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® 278 is 7.0 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 used. In addition, as Santicizer® 278 is readily biodegradable it is not classified as persistent. As such, the R11 Information Requirements specify that further data on bioaccumulation is not required to be generated.

The Bioconcentration Factor (BCF) of Santicizer 278 was calculated using the "modified Connell" parabolic equation provided in the R.7c Information Requirements guidelines and using the estimated log Kow of 7.0. A Bioconcentration Factor (BCF) of 45709 l/kg (log BCF of 4.66) was calculated using this equation.

Sancticizer® 278 is therefore potentially Bioaccumulative (B) and/or very Bioaccumulative (vB).

Toxicity (T) Assessment:

As Sancticizer® 278 is not P/vP but potentially B/vB a toxicity assessment is not required. However, Santicizer® 278 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 Sancticizer® 278 is non-toxic to aquatic organisms following long-term exposure at the limit of water solubility. Therefore, it 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.

Sancticizer® 278 does not meet the criteria for Toxicity (T).

Conclusion of PBT/vPvB assessment

The available data showed that Sancticizer® 278 is not P/vP, potentially B/vB but not T.

Sancticizer® 278 is therefore not PBT or vP/vB.