Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
In accordance with section 9.2.2.1 column 2 of the Annex VIII of the REACH Regulation, the test item has not been tested for toxicity to fish. Indeed, the test item is expected to show a very low solubility and no toxicity to fish based on available information on other aquatic organisms.
These points are elaborated in the two following paragraphs.

1) Cistus concrete has not been tested for determination of solubility due to identified technical issues. However, during OECD 202 study on the test item, a TOC analysis has been performed in order to provide an indication of the concentration of dissolved organic material in the WAFs. Every effort was made to solubilize the soluble fraction during WAF preparation, but analytical results indicated that amounts of organic compounds from the test item dissolved in the water phase were not very significant (in fact unquantifiable for the test loading rate of 10 mg.L-1), except at the loading rate of 1000 mg.L-1 where the test item was probably in excess and where presence of residual particles was suspected.

2) The acute toxicity of Cistus concrete to Daphnia magna has been assessed during a study following OECD guideline.
After 24 and 48 hours of exposure, no immobilisation of the test animals was observed in the control and the nominal test concentration 10 mg.L-1 (loading). Only one daphnid was immobilised at the loading rate 100 mg.L-1. A residual particle of the non-soluble fraction was probably the cause of this immobilisation (physical effect) rather than a potential toxicity due to the test substance (no effects on other daphnids at the same loading rate). The 24 and 48-hour EL50 was therefore > 100 mg test item.L-1 (loading).
The acute toxicity of Cistus concrete to algae has been derived from experimental data on substance Labdanum Gum. Based on available data on aquatic toxicity and on solubilization of both substances, it is expected that these substances exhibit the same behavior in aquatic mediums. 72h-ErL50 of Cistus concrete to aquatic algae is determined to be >1000 mg/L.
Regarding these data, the test item is not expected to show a toxic effect to fish at the tested loading rates.
Considering the absence of toxic effects on aquatic invertebrates and algae at tested highest loading rates and the apparent low solubilisation of the test item, toxicity to fish is not expected, therefore it is not deemed necessary to perform a study on vertebrate.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion