Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

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Additional information

Determination of the potential for bioaccumulation follows Guidance on Information Requirements and Chemical Safety Assessment Chapter R.16: Environmental Exposure Estimation (ECHA, 2012). Chapter R.16 and REACH Annex IX states that there may be bioaccumulation potential if log Kow is >3. Experimentally measured Log Kow for Hydrotrope Category substances range between -3.18 to 0.07. The likelihood of bioaccumulation is very low and the requirement for further testing is waived.

In addition, scientific evidence in the published literature indicates that bioaccumulation of the test substance in the aquatic environment is unlikely. Experimental studies carried out in accordance with OECD Guideline 305C were considered to be reliable (Klimisch 2) in the evaluation of two hydrotrope category substances by the OECD SIDS SIAR Report (2006) authors. Both aquatic tests determined bioconcentration factors of <2.3.

The requirement for bioaccumulation testing in the aquatic environment (REACH Annex IX) is waived based on the weight of evidence from the measured Log Kow values of -3.18 to 0.07 for Hydrotrope Category substances and the two bioaccumulation in fish studies with reported BCF of less than 2.3. The likelihood of bioaccumulation is considered to be very low. Based on the evidence confirming bioaccumulation is unlikely to occur in aquatic organisms, the endpoint for terrestrial organisms is also waived.