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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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: 

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).

In a key OECD Guideline 301B ready biodegradability study (ABC Laboratories Ltd., 2016b), the mean percent theoretical CO2 produced by test substance (Santicizer P1700) was 31.1% by Day 29 of the study. Since the biodegradation value was less than 60%, Santicizer P1700 cannot be classified as readily biodegradable, but may be inherently biodegradable. The read-across analogue Santicizer 278 is readily biodegradable.

Without further data it is not possible to say whether the substance would be persistent or not.

The default conclusion for an inconclusive persistence assessment is that the substance may potentially be P/vP.

Bioaccumulation (B) Assessment: 

Santicizer P1700 has a log Kow of 4.36 and as such can be screened as not B/vB according to the R.11 information requirement guidance.

Santicizer P1700 can therefore be considered not B/vB

Toxicity (T) Assessment: 

Environmental Toxicity (T): 

No toxic effects have been detected in short or long term ecotoxicological studies at the limit of solubility for the substance.

Human Health Hazards Assessment (T) 

Santicizer P1700 is not classified for any human health endpoints and is not considered CMR.

The substance Santicizer P1700 is not considered T based on human health or environmental end-points.

Conclusion of PBT/vPvB assessment 

Santicizer is considered P/vP based on a lack of conclusive biodegradation data. It is however not classified as B/vB due to it’s low log Kow of 4.36. It also does not meet the criteria for T. Therefore, Santicizer P1700 is not classified as PBT or vP or vB.