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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Persistence

Each component of the reaction mass of 2,4-bis(xylylazo)resorcinol, 2,4-bis[(4-dodecylphenyl)azo]resorcinol, and 2-[(4-dodecylphenyl)azo]-4-(2,4-xylylazo)resorcinol is estimated to be not readily biodegradable based on the QSAR US EPI SUITE BIOWIN outputs.

Therefore the substance does meet the “P” criterion. 

 

Bioaccumulation

The log kow for the substance was determined to be > 6.5 by HPLC estimation. In accordance with the screening criteria for bioaccumulation in the ECHA Guidance (Chapter R.11 PBT Assessment) the substance would screen as a potential bioaccumulative substance. The likely reliability of the log Kow is however, considered to diminish above a value of 6, as noted in Appendix R.11-1 Annex 1 of ECHA guidance on PBT assessment. Substances with log Kow between 4.5 and 6 are considered likely to be highly accumulating; however no substantial bioconcentration is assumed having a log Kow value greater than 6. For compounds having a log Kow greater than 6, a gradual decrease of BCF is observed and it has been hypothesised within the published literature that a high log Kow is more an effect of solubility than a tendency of the substance to be lipophilic.

On the basis of the available information the substance is not considered to be bioaccumulative.

 

Toxic

The substance is not classified as a Carcinogen, Mutagenic, Reproductive/developmental toxicant. The substance is however classified as STOT RE 2 on the basis of effects shown in a OECD 422 study using rats, where vital organs such as the oesophagus, stomach, thymus, thyroid gland and parathyroid gland.

The substance is therefore considered to meet the criteria for “T”.

 

Conclusions

The substance meets the criteria for Persistence based on the estimated biodegradability of the primary components of the substance, additionally the substance is concluded to be Toxic from the assignment of the STOT RE 2 classification in accordance with the principles set out by the CLP Regulation. Bioaccumulation is not predicted for the substance on the basis of the log Kow > 6.5 and the gradual decrease of BCF being hypothesised.

Overall the substance is not considered to be a PBT/vPvB substance.