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:
JUSTIFICATION FOR DATA WAIVING
In accordance with Annex IX, section 9.1, column 2 of REACH Regulation, long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms.
Based on the available environmental test data, the substance is not considered to have any adverse effects. Short term tests with several species are available (acute fish study, Klimisch 2; OECD TG 203; acute daphnia study, Klimisch 2, OECD TG 202; algae growth inhibition study, Klimisch 2, OECD TG 201). All tests were performed using either direct application of the test substance (acute fish study) or water accommodated fractions (acute daphnia and algae study). The following results were obtained in the short term toxicity studies:
LL50 (fish) > 1000 mg/L (nominal; precipitation observed)
EL50 (daphnia) ≥ 10000 mg/L (nominal)
EL50 (algae) > 1000 mg/L (nominal)
No abnormal behaviour was observed for fish and daphnia. No growth inhibition was observed for algae at the highest tested loading. The algae test further resulted in an extrapolated EL10 of 41 mg/L. This value was plausible, because the inhibitory effect showed a relatively weak dose-response relationship, with no unequivocal dose response discernible from 100 to 400 mg/L.
Based on the above results the test substance does not need to be classified and labelled according to Regulation (EC) No. 1272/2008.
According to Regulation (EC) No 1907/2006 (REACH) Article 14(4), no additional steps on chemical safety assessment are needed, because the test substance does not fulfil the criteria for any of the hazard classes listed in part 4 (a) to (d). In conlusion, the chemical safety assessment showed no need to further investigate the long-term aquatic toxicity.
Furthermore the test substance is composed of quartz (SiO2) and chalk (CaO). Both are natural constituents of different type of soils (e.g. sand) and can be found ubiquitous in nature. Observations show that environmental organisms show a high tolerance towards constituents of sand. Therefore an adverse effect on environmental organisms can be excluded and a test is scientifically not justified.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion