Registration Dossier

Administrative data

Endpoint:
fish early-life stage toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
Step 1: Evaluation of information.
The substance is soluble and stable in water, not subject to hydrolysis and not readily biodegradable. The substance would clearly be persistent in the environment.

Following acute exposure to fish, Daphnia, algae or aquatic microorganisms the substance displays a complete lack of effects to any of the species. All exposures were concluded as limit tests. The substance is not toxic to any aquatic organisms.

The substance has an extremely low partition coefficient, with a log Pow of -0.1. Furthermore, the BCF is measured as 7.7, so the substance would not be bioaccumulative in the environment.

PBT assessment
Assessed composition:
Overall conclusion: Based on the assessment described in the subsections above the submission substance is not a PBT / vPvB substance.
Justification:
The substance is soluble and stable in water. It is not prone to degradation due to hydrolysis, achieving a half life in excess of 1 year. Furthermore, under the conditions of the ready biodegradation test, the substance is not prone to ready biodegradation. The substance is considered to be persistent.
The substance is soluble and stable in water. In the log kow screening test, the substance achieved a log Pow of -0.1.
The substance is considered to have no potential for bioaccumulation.
The substance is soluble and stable in water. All data prepared to assess the pot6ential toxicity of the substance to aquatic species achieved limit values. No toxicity was observed upto the available concentrations tested.
The mutagenic potential has been assessed in vitro and in vivo. The substance displays no potential for mutagenicity and this is suggestive that the substance is no likely to carcinogenic. Furthermore, toxicity of high dose animals has been observed in the screening reproductive toxicity test, but the data has determined a clear No adverse effect level and the data does not display effects of reproductive toxicity.
Data are available from subacute exposure only. The data do not, however, identify any hazard for which chronic assessment is considered relevant and the substance is not classified for repeated dose toxicological effects.
The substance is not unduly toxic.
On the basis of the available data the substance is not a PBT substance.

Step 2: Classification and Labelling.
Although the substance is persistent, a complete absence of effects noted by exposure to three trophic levels of aquatic organism means that the substance is not classified for environmental effects.

Step 3: Derivation of the PNEC.
Due to a complete absence of effects to aquatic organisms, Derived No Effect Concentrations cannot be derived since the concentration at which effects may occur exceeds the limit of measurement required under OECD compliant test guidelines. Similarly, PNECs cannot be derived as the concentration for no effects also exceeds the limit of measurement required under OECD guidelines.

In accordance with Column 1 and 2 of Annex IX assessment under Annex I of the REACH regulation indicates an absence of effects and determines that further investigation of effects is not required. It can be adequately predicted that effects in chronic exposure will exceed the maximum limit of exposure required under OECD test guidelines.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion