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EC number: 701-008-3
CAS number: -
criteria and justification
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).
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
such, Sancticizer® 278 is by default considered not Persistent (P)
and/or very Persistent (vP).
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.
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.
278 is therefore potentially Bioaccumulative (B) and/or very
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.
278 does not meet the criteria for Toxicity (T).
of PBT/vPvB assessment
available data showed that Sancticizer® 278 is not P/vP, potentially
B/vB but not T.
278 is therefore not PBT or vP/vB.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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