Registration Dossier

Administrative data

Endpoint:
long-term toxicity to birds
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Avian toxicity data is used in the assessment of secondary poisoning risks for the aquatic and terrestrial food chains. Exposure of birds is generally only considered for the fish and earthworm food chains following the release of a susbtance via a sewage treatment works. If the secondary poisoning assessment shows no conern for secondary poisoning then further investgation of chronic avian toxicity is unnecessary (ECHA Guidance on Information Requirements and Chemical Safety Asessment, Chapter R.7c, v 3.0 June 2017).

Based on the available information, there is no indication of a bioaccumulation potential and, hence, secondary poisoning is not considered relevant.
The substance has a partition coefficient (n-octanol/water) of log Pow -0.45. The substance is therefore considered to have low potential to bioaccumulate in aquatic organisms. No specific mechanism of uptake apart from lipophilic partitioning is known. The low adsorption coefficient of log Koc <1.25 indicates the substance has low potential for adsorption and accumulation in soil (or sediment) and therefore bioaccumulation in terrestrial organisms is not anticipated to be of concern.

The substance also hydrolyses rapidly in water (estimated half-life <2 minutes) which further limits the bioaccumulation potential. The proposed hydrolysis product, Hydroxyethyl sulphate, is also expected to have low bioaccumulation potential and low potential for adsortion to soils, based on predicted log Pow -3.95 and log Koc <1.

Therefore, it is considered that there is a low exposure potential to birds and that a long-term or reproductive toxicity to birds test is not necessary.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion