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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Short-term toxicity to fish:

The acute lethal toxicity (LC50) of Amine fluoride 297 (Olaflur) to Poecilia reticulata (Guppy) was investigated under static conditions over a period of 96 h. 7 fish per concentration were exposed to the test substance. The nominal active ingredient (a.i.) concentration of Aminfluorid 297 Olaflur as selected by a range finding test was 0.1, 0.2, 0.4, 0.8 and 1.6 mg/L, respectively. The individual test concentrations were prepared by dilution of a stock solution. No chemical analysis of test concentrations was conducted.

In the definite test all fish died at the nominal test concentration of 0.4, 0.8 and 1.6 mg/L after 24 h exposure. At 0.2 mg/L all fish had died after 48 h of exposure. No mortality was observed at 0.1 mg/L and in the control after 96 h exposure. Other toxic effects than mortality, e.g. loss of coordination, hypoactivity and swimming on the back, were seen at 0.2 mg/L and higher concentrations. Based on these data it was not possible to calculate the LC values by regression analysis. Therefore, the nominal lethal concentration (LC50) of Aminfluorid 297 Olaflur to Poecilia reticulata was calculated as the geometric mean of the highest concentration causing no mortality (0.1 mg/L) and the lowest concentration producing 100 % mortality (0.2 mg/L) to be 0.15 mg/L. The no-observed-effect concentration (NOEC) was 0.1 mg/L. 100 % mortality (LC100) was seen at the nominal concentration of 0.2 mg/L.

Short-term toxicity to aquatic invertebrates:

The purpose of this study was to evaluate the influence of the test item Olaflur on the mobility respectively survival of Daphnia magna. Young Daphnia were exposed in a static test to the test item for 48 hours, added to test water at a range of concentrations. The test item concentration of the test solutions was measured by HPLC/MS/MS method at the start and at the end of the test. The nominal test item concentrations were 0.063; 0.125; 0.25; 0.5, 0.75 and 1 mg test item/L (63; 125; 250; 500; 750 and 1000 ug/L). The highest nominal concentration was 1 mg/L (1000 ug/L). At the start of the test the measured concentrations at the nominal concentrations of 0.125, 0.25, 0.5, 0.75 and 1 mg/L were above the quantification limit (the limit of quantification of the analytical method was 19.3 ug/L that equivalent with 0.0193 mg/L) of the analytical method; however, these measured test item concentrations were 31-64 % of the nominal only. Due to the adsorptive properties of Olaflur, pre-conditioning of the test vessels was necessary. In the main experiment, results obtained from reference samples (without Daphnia), in which a good recovery was noted even at the end of the test period, supported the assumption that the test item adsorbs to the biological material (the daphnids). So, these additional investigations revealed that the low recovery was due to the presence of test organisms and not due to limited homogeneity or stability in the test medium. This is also supported by the observations made in the long-term Daphnia study with the free amine base of the fluoride salt (= Olaflur). This leads to the conclusion that the organisms were fully exposed to the bulk concentration of the test substance during the test. Thus, all effect values are therefore given based on the nominal test item concentrations (for details see Section 6.1.4).

Long-term toxicity to aquatic invertebrates:

A flow-through life-cycle toxicity test with Daphnia magna was perfromed according to OECD guideline 211. The cladoceran, Daphnia magna, was exposed to Olaflur at the following nominal concentrations 13, 25, 50, 100 and 200 µg/L corresponding to the mean measured concentrations of 11, 18, 42, 83 and 180 µg/L under flow-through conditions for 21 days. There were no statistically significant treatment-related effects on reproduction or growth at concentrations ≤180 µg/L in comparison to the negative control. Survival was the most sensitive biological endpoint measured in the study. Daphnids exposed to Olaflur at a mean measured concentration of 180 µg/L had a biologically meaningful reduction in survival in comparison to the negative control.
Consequently, the overall NOEC for the study was determined to be 83 µg/L and the LOEC was determined to be 180 µg/L. The EC10 value for survival was estimated to be 81 µg/L, with a 95% confidence interval of 51 to 129 µg/L, while the EC20 value was estimated to be 127 µg/L, with a 95% confidence interval of 70 to 174 µg/L. The EC50 value for survival was empirically estimated to be greater than the highest test concentration, since there was less than a 50% decrease in survival in any treatment group in comparison to the negative control. Since there was less than 10% inhibition in any treatment for the reproduction and growth endpoints in comparison to the negative control, the IC10 and IC20 values were empirically estimated to be >180 µg/L, the highest concentration tested.

Toxicity to aquatic algae and cyanobacteria:

The test substance, Olaflur, was tested in a toxicity test with the freshwater algae Raphidocelis subcapitata according to OECD Guideline 201. The algae were exposed to the test item for 72 hours at concentrations of 6.3, 13, 25, 50 and 100 µg/L which corresponds to the geometric mean measured test item concentrations of 3.4, 5.4, 8.0, 14 and 39 µg/L. After 72 hours of exposure, inhibition of cell density in the 3.4, 5.4, 8, 14, and 39 µg/L treatment groups was 4, 18, 86, 99, and 100%, respectively, relative to the negative control. Inhibition of yield in the 3.4, 5.4, 8, 14, and 39 µg/L treatment groups was 4, 18, 86, 99, and 100%, respectively, relative to the negative control. Inhibition of growth rate in the 3.4, 5.4, 8, 14, and 39 µg/L treatment groups was 1, 4, 35, 83, and 100% respectively, relative to the negative control.  Mean cell density and mean yield, were significantly reduced (Dunnett’s t-test; p ≤ 0.05) in the 5.4, 8.0, 14, and 39 mg/L treatment groups at 72 hours, when compared to the negative control. Mean growth rate was significantly reduced (Jonckheere-Terpstra Step-Down Trend test; p ≤ 0.05) in the 5.4, 8.0, 14, and 39 mg/L treatment groups at 72 hours, when compared to the negative control. Effects were evaluated based on cell density, yield, and growth rate. The 72 hour EC50, EyC50, and ErC50 values were determined to 6.5, 6.3, and 9.5 µg/L, respectively. The 72 hour ErC10 was determined to be 5.7 µg/L and the NOEC was determined to be 3.4 µg/L.

Toxicity to microorganisms:

Seven concentrations of the test item ranging from 10000 to 10 mg/L (nominal) were tested. Duration of the test was three hours. Activated sludge taken from a domestic sewage treatment plant and washed before usage, was used as inoculum. The dry matter was determined as 3.70 g suspended solids/L, giving a concentration of 1.48 g suspended solids/L in the test.

3,5-Dichlorophenole was used as positive control. Four concentrations were tested; an EC50 of 6.7 mg/L (95% confidence interval: 5.7 – 7.6 mg/L) was determined, which lies within the demanded range of 5 – 30 mg/L. All treatments, except for the lowest concentration (10 mg/L), showed inhibition of the respiration rate of the activated sludge. A dose-response-relationship could be established.

For the determination of the biological results, all inhibition values were evaluated. The mean of the O2-consumption of the controls was determined as 24.2 mg/L*h (standard deviation 1.1 mg/L*h). This means that the range of O2-consumption for the determination of the NOEC is 22.0 – 26.4 mg/L*h. Therefore, treatment 32 mg/L (O2-consumption rate 23.3 mg/L) was stated as NOEC.

All validity criteria were met. For the estimation of the EC50s of test item and positive control, the fits showed good statistical correspondence of the data with the dose-response-equation. Variation of the controls was below the recommended limit of 15%. Inhibition in the treatments 10000 – 1000 mg/L Olaflur was in a range of 100 – 85 %. In these treatments, pH was acidic (4.9 – 6.6). But in the treatment containing 316 mg/L test item, pH was 7.87, which is in the same range as in the controls. Nevertheless, 66 % inhibition was observed. Therefore, it is concluded that the inhibition values in the upper treatments are not (or at least not solely) caused by the low pH value. The result of the test can be considered valid. The EC50 to activated sludge was determined to be 240 mg/L.