Registration Dossier

Diss Factsheets

Ecotoxicological information

Toxicity to soil microorganisms

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
toxicity to soil microorganisms
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
According to REGULATION (EC) No 1907/200, Annex XI, toxicity testing to terrestrial soil microorganisms was waived based on the available data and weight of evidence. Further testing is regarded as scientifically not justified. Based on the information currently available on the substance, the substance is not considered to be a PBT or vPvB. Aquatic acute toxicity was assessed at 3 trophic levels; fish, aquatic invertebrates (Daphnia) and aquatic plants (algae). The respective EC50/LC50 values for fish, Daphnia and algae, indicated the test material was unlikely to be toxic to the aquatic environment owing to the low aqueous solubility and lack of toxicity observed in aquatic species up to the limit of aqueous solubility. The test material also has a low partition coefficient (Log Kow 2.3), indicating that bioaccumulation is not expected in the aquatic environment. No toxicity was observed in the activated sludge respiration inhibition test, indicating low potential for toxicity to sewage treatment plant micro-organisms. Thus, the test item is also not expected to induce toxicity in terrestrial organisms.
During use as thermal developer the substance is included in three-dimensional matrices and completely retained, therefore, no direct or indirect release into the terrestrial compartment is expected. The thermo paper will not be recycled (legal requirement in Europa) and the STP sludge will be burned and no exposure is expected afterwards.
However, a study to determine the long-term toxicity to terrestrial invertebrates (OECD 222) is planned in order to generate useful and reliable data which will be sufficient for the soil risk assessment.

Description of key information

Key value for chemical safety assessment

Additional information