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 did not exhibit toxic effect to aquatic invertebrates and algae during experimental short-term ecotoxicity studies.
 These points are elaborated in the two following paragraphs.

1) Labdanum gum has not been tested for determination of solubility due to identified technical issues. However, DOC measurements and quantification of two constituents during ecotoxicological studies give sufficient information to conclude on insolubility of the substance. COD analyses during acute toxicity tests of the substance to Daphnia magna (OECD 202, LPL, 2016) and to P. subcapitata (OECD 201, LPL, 2016) indicate that unquantifiable organic compounds were found in WAF at loading rates below 100 mg/L.
The low variation in COD measurements (less than 1 mg O2.L-1) during OECD 202 study between control samples and samples with loading rates from 1 to 100 mg test item.L-1 indicates that constituents of the test item are poorly solubilised.

2) The acute toxicity of Labdanum Gum to Daphnia magna has been assessed during a study following OECD guideline 202. After 48 hours of exposure, no immobilisation of the test animals was observed in the control and the nominal test loading rates of 1.0 and 10 mg.L-1. Only 10% immobilisation was observed at the nominal test loading rate of 100 mg.L-1 but this was probably not a substance related effect. The 24 and 48-hour EC50 was therefore > 100 mg test item.L-1 (loading).
The substance was also tested to assess its ability to generate toxic effects in Pseudokirchneriella subcapitata following OECD guidance 201. No inhibition of algal growth relative to control values was observed in any of the test loading rates (100 and 1000 mg.L-1). ECx values could not be determined. The 72h-NOEC was > 1000 mg test item.L-1 (loading rate). Regarding these data, the test item is not expected to show a toxic effect to fish at the tested loading rates.
These results are compliant with the expected insolubility of the substance as developed in the paragraph above. 

Considering the absence of toxic effects on aquatic invertebrates and algae at tested highest loading rates and the apparent low solubilisation of constituents of the substance, 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