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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Short-term toxicity to fish

In the key study, performedusing Oncorhynchus mykiss, the LC50 (96 h) was determined to be 1.7 mg/L. The highest test concentration resulting in 0 % mortality was determined to be 1.0 mg/L, the lowest test concentration resulting in 100 % mortality was determined to be 3.2 mg/L and the NOEC was reported as 1.0 mg/L (OECD Guideline No. 203 referenced as Method C.1 of Commission Directive 92/69/EEC). In a supporting study, performed using Oncorhynchus mykiss, the LC50 (96 h) was reported as 1.7 mg a.i./L. The NOEC was determined to be 1.3 mg a.i./L. (equivalent or similar to EPA OTS 797.1400 Fish Acute Toxicity Test).

Long-term toxicity to fish

In a study performed using Pimephales promelas, the 33-d NOEC was determined to be 0.455 mg a.i./L (nominal) based on post-hatch survival. The NOEC for growth (length, wet weight, dry weight) was ≥ 1 mg a.i./L (OECD TG 210).

Short-term toxicity to aquatic invertebrates

In the key study, performed using Daphnia magna Strauss, the EC50 (48 h) was determined to be 2.5 mg/L and the NOEC was reported as 1.0 mg/L at 48 hours (OECD Guideline No. 202 referenced as Method C.2 of Commission Directive 92/69/EEC). In a supporting study, performed using Daphnia magna, the EC50 (48 h) was reported as 4.3 mg a.i./L. The NOEC was determined to be 1.6 mg a.i./L (TSCA Test Standard 797 -1300; equivalent or similar to EPA OTS 797.1300 Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids).

Long-term toxicity to aquatic invertebrates

In a study performed using Daphnia magna, taking all biological parameters and assessed endpoints into account, the 21-d NOEC was determined to be ≥ 2 mg a.i./L (OECD TG 211).

Toxicity to aquatic algae

In a study performed using Desmodesmus subspicatus (previous name: Scenedesmus subspicatus) the EbC50 (72 h) value based on biomass was determined to be 45mg/L and the ErC50 (24-48 h) value based on growth rate was determined to be 42 mg/L. The No Observed Effect Concentration (NOEC) was reported as 15 mg/L (OECD 201 and EU Method C.3).

Additional information

Short-term toxicity to fish

In the key GLP study performed according to OECD 203 and EU Method C.1 (Handley et al, 1994) Oncorhynchus mykiss were exposed to five nominal concentrations of test material plus dechlorinated laboratory tap water control as the control for 96 hours under semi-static conditions. Ten fish were placed into the test chamber for each treatment group and the control group. Nominal concentrations of test item selected following a range-finding study were 1.0, 1.8, 3.2, 5.6 and 10 mg/L. Verification of test item concentration took place at 0, 24 and 96 hours using a spectrophotometric method. Chemical analysis showed the measured test concentrations to be near nominal and LC50 values were calculated in terms of nominal concentrations. No abnormalities were detected in the control group or the 1.0 mg/L test item group during the 96 hour test period. However, abnormalities were reported at other test concentrations and all fish in the 3.2, 5.6 and 10.0 mg/L test groups died during the study. The LC50 (96 h) value was determined to be 1.7 mg/L. The highest test concentration resulting in 0 % mortality was determined to be 1.0 mg/L, the lowest test concentration resulting in 100 % mortality was determined to be 3.2 mg/L and the No Observed Effect Concentration (NOEC) was reported as 1.0 mg/L.

In a non-GLP supporting study (Collins, 1993) Oncorhynchus mykiss were exposed to seven nominal concentrations of active ingredient plus reconstituted, deionised, well water as the control for 96 hours under static conditions. These systems were maintained in duplicate and ten fish were placed into the test vessel for each replicate (20 fish per treatment level and the control group). Based on the results of a preliminary study, nominal concentrations of 0.47, 0.79, 1.3, 2.3, 3.6, 6.0 and 10 mg a.i./L were chosen for the definitive study. Analytical monitoring of active ingredient concentration was not performed. Mortality of 100 % was observed among fish exposed to 3.6, 6.0 and 10 mg a.i./L after 24 hours exposure. No mortality or sublethal effects (e.g. loss of equilibrium) were observed at test termination for fish exposed to 0.47, 0.79 and 1.3 mg a.i./L test concentrations. Based on these data it was established that the effects observed were dose dependent and the LC50 (96 h) was reported as 1.7 mg a.i./L. The No Observed Effect Concentration (NOEC) was determined to be 1.3 mg a.i./L.

Long-term toxicity to fish

The chronic toxicity of the registered substance to the early-life stages of the fathead minnow (Pimephales promelas) was determined in a GLP study performed according to OECD TG 210 (Hills, 2022).

Newly fertilised (<24 hours old) eggs of Pimephales promelas were exposed to the registered substance to 28 days post hatch (33 days in total) at nominal concentrations of 0 (dilution water control) 0.043, 0.094, 0.207, 0.455 and 1.0 mg a.i./L. A flow-through dosing design was used with 4 replicates per treatment. The test was performed at a nominal temperature of 25 ± 1.5°C. 

To confirm the actual exposure concentrations being achieved, the concentrations of eight components of the registered substance in the test solutions were measured using a LC-MS/MS method. Measurement of three of the major individual components of the registered substance (C12, C14 and C18-α-sulfo, 1-methyl esters, sodium salts) using this method was validated in a separate study. The method also measured C16-α-sulfo, 1-methyl esters, sodium salts (which did not meet the acceptance criteria of the method validation study) and four of the minor individual components of the registered substance (C12, C14, C16 and C18-α-sulfo, disodium salts) but measurement of these components using this method was not validated. 

A single replicate test vessel from each treatment was sampled and measured at each time point. Samples of the dosing stock solutions were taken and measured on Day -3 (pre-exposure). 

Measured concentrations of the four major individual components during the exposure were as follows:

- C12-α-sulfo, 1-methyl esters, sodium salts ranged between 60-98% of nominal;

- C14-α-sulfo, 1-methyl esters, sodium salts ranged between 57-102% of nominal;

- C16-α-sulfo, 1-methyl esters, sodium salts ranged between 55-132% of nominal;

- C18-α-sulfo, 1-methyl esters, sodium salts ranged between 55-314% of nominal. 

The variability of the measured concentrations in the test aquaria was thought to be due to the properties of the UVCB test substance as the dosing stock solution and dilution water flow rates into the mixing chambers were confirmed to be within ±10% at each timepoint throughout the test (with exceptions as noted). Additionally, the concentrations of the four major and four minor components of the test substance were measured in the dosing stock solutions on Day -3 (pre-exposure) and ranged between 86-120% of nominal. 

Measured concentrations of the fortified recovery samples for the four major individual components during the exposure (Table 2) were as follows:

- C12-α-sulfo, 1-methyl esters, sodium salts ranged between 81-111% of nominal;

- C14-α-sulfo, 1-methyl esters, sodium salts ranged between 87-110% of nominal;

- C16-α-sulfo, 1-methyl esters, sodium salts ranged between 87-112% of nominal;

- C18-α-sulfo, 1-methyl esters, sodium salts ranged between 89-117% of nominal. 

As multiple components of the test substance were measured, nominal concentrations were used for calculation and reporting of results, with measured concentrations for each individual component presented separately. 

The range of percentage hatch success across all replicates in the test was 90 to 100%. The mean percentage hatch success across all replicates in the dilution water control was 98%. No significant differences (p <0.05) were found between the dilution water control and the treatment concentrations for hatch data (Chi2 2x2 Table Test with Bonferroni correction).

The range of percentage survival post-hatch across all replicates was 72 to 94%. The mean percentage survival post-hatch in the dilution water control was 90%. A significant difference (p > 0.05) was found between the dilution water control and the nominal 1.0 mg a.i./L concentration (Chi2 2x2 Table Test with Bonferroni correction). 

The total lengths of the fry in the dilution water control ranged from 10.77 to 25.81 mm with a mean of 22.05 mm. The mean length of the dilution water control exceeded the 18 mm typical control minimum mean total length requirement of the OECD 210 TG. No significant differences (p <0.05) were found between the mean total length (per replicate) of the dilution water control and the nominal 0.043, 0.094, 0.207, 0.455 and 1.0 mg a.i./L test concentrations (Multiple Sequentially-rejective Welch t-test after Bonferroni-Holm correction).

The wet weights of the fry in the dilution water control ranged from 0.00961 to 0.16421 g with a mean of 0.10388 g. No significant differences (p <0.05) were found between the wet weight in the dilution water control and the nominal 0.043, 0.094, 0.207, 0.455 and 1.0 mg a.i./L test concentrations (Multiple Sequentially-rejective Welch t-test after Bonferroni-Holm correction). 

The calculated dry weights of individual fry (estimated using the dry weight of the pooled fry from each replicate) in the dilution water control ranged from 0.01863 to 0.02279 g with a mean of 0.02130 g. No significant differences (p <0.05) were found between the dry weight of the dilution water control and the nominal 0.043, .0.094, 0.207, 0.455 and 1.0 mg a.i./L test concentrations (Multiple Sequentially-rejective Welch t-test after Bonferroni-Holm correction).

Based on these findings, the following NOEC/LOEC were reported:

Survival (post-hatch): NOEC = 0.455 mg a.i./L; LOEC = 1 mg a.i./L

Growth (length): NOEC ≥ 1 mg a.i./L; LOEC > 1 mg a.i./L

Growth (wet weight): NOEC ≥ 1 mg a.i./L; LOEC > 1 mg a.i./L

Growth (dry weight): NOEC ≥ 1 mg a.i./L; LOEC > 1 mg a.i./L

Short-term toxicity to aquatic invertebrates

In the key GLP study performed according to OECD 202 and EU Method C.2 (Handley et al, 1994) Daphnia magna were exposed in duplicate to nine nominal concentrations of test material plus reconstituted water as the control for 48 hours under static conditions (20 animals per concentration; 10 daphnids per replicate). Nominal concentrations of test item selected following a range-finding study were 1.0, 1.8, 3.2, 5.6, 10, 18, 32, 56 and 100 mg/L. Verification of the control, 1.0, 3.2, 10, 32 and 100 mg/L test item concentrations took place at 0 and 48 hours using a spectrophotometric method. Chemical analysis showed the measured test concentrations to be near nominal and LC50 values were calculated in terms of nominal concentrations. The EC50 (48 h) value was determined to be 2.5 mg/L and the No Observed Effect Concentration (NOEC) was reported as 1.0 mg/L at 48 hours.

In a non-GLP supporting study (Collins, 1993) Daphnia magna were exposed to seven nominal concentrations of active ingredient plus fortified well water as the control for 48 hours under static conditions. Five replicates were established for each test concentration and the control. Five daphnids were placed into each vessel (four replicates containing test item plus the control vessel). Based on the results of a preliminary study, nominal concentrations of 1.6, 2.6, 4.3, 7.2, 12 and 20 mg a.i./L were chosen for the definitive study. Analytical monitoring of active ingredient concentration was not performed. After 24 hours exposure, 100 % immobilisation was observed among daphnids exposed to the two highest concentrations (12 and 20 mg a.i./L). At test termination (48 hours), immobilisation was observed among daphnids exposed to the 4.3 and 7.2 mg a.i./L treatment levels. The levels of immobilisation were 55 % and 90 % respectively. Immobilisation of 5 % was observed among daphnids exposed to the 2.6 mg a.i./L treatment level. Sublethal effects (e.g. lethargy, erratic behaviour) were observed among several of the mobile daphnids exposed to the 4.3 mg a.i./L treatment level. No immobilisation or sublethal effects were observed among daphnids exposed to the remaining concentration tested (1.6 mg a.i./L). Based on these data it was established that the effects observed were dose dependent and the EC50 (48 h) was reported as 4.3 mg a.i./L. The No Observed Effect Concentration (NOEC) was determined to be 1.6 mg a.i./L.

Long-term toxicity to aquatic invertebrates

The chronic toxicity of the registered substance to D. magna was determined in a GLP study performed according to OECD TG 211, Daphnia magna Reproduction Test (Nelson, 2022). 

D. magna (Clone A), < 24 hours old were exposed to the registered substance for 21 days at nominal concentrations of 0 (control) 0.09, 0.20, 0.43, 0.90 and 2.0 mg a.i./L. A semi-static (renewal every day) test design was used with ten replicates per treatment. The nominal test temperature was 20 -24, kept constant within ± 2 °C. 

To establish the concentrations achieved eight components of the registered substance in the test solutions were measured using a liquid chromatography – mass spectrometry (LC-MS/MS) method. The analytical method was successfully validated for the analysis of three of the major individual components of the test substance (C12, C14 and C18-α-sulfo, 1-methyl esters, sodium salts). The method also measured C16-α-sulfo, 1 methyl esters, sodium salts (which did not meet the acceptance criteria of the method validation study) and four of the minor individual components of the test substance (C12, C14, C16 and C18-α-sulfo, disodium salts) but measurement of these components using this method was not validated. 

The individual pooled sample of each test concentration replicate was sampled for each treatment and measured at each time point.

Measured concentrations of the four major individual components during the exposure were as follows:

- C12-α-sulfo, 1-methyl esters, monosodium salts ranged between 35-144% of nominal;

- C14-α-sulfo, 1-methyl esters, monosodium salts ranged between <LOQ-126% of nominal;

- C16-α-sulfo, 1-methyl esters, monosodium salts ranged between <LOQ-104% of nominal;

- C18-α-sulfo, 1-methyl esters, monosodium salts ranged between <LOQ-124% of nominal.

Throughout the study the analysis of the monosodium-C12component was inconsistent, with notable levels of response drift during the analytical sequences. Frequent placement of suitable concentration quality control standards allowed assessment of the level of response drift and subsequent adjustment of the analytical results for the study samples and other unknown solutions in accordance with Scymaris’ standard operating practice. In some instances, the associated acceptance criteria were not fully met. Therefore, these data should be treated with caution but are included for consistency.

On Day 13 and Day 14 Mono-C12 failed to meet all critical analytical method validity criteria. The following criteria failed: response drift throughout run. All samples, following response drift were quantified using bracketing standards quantitation which did not fully pass acceptance criteria. The only part of the test sequence where the response drift could not be accounted for was used to analyse the spike samples (and DWC sample), therefore, these results are not reported. All other data passed the acceptance criteria with the use of bracketing standards quantitation.

Measured concentrations of the fortified recovery samples for the four major individual components during the exposure were as follows:

- C12-α-sulfo, 1-methyl esters, monosodium salts ranged between 45-221% of nominal;

- C14-α-sulfo, 1-methyl esters, monosodium salts ranged between 81-104% of nominal;

- C16-α-sulfo, 1-methyl esters, monosodium salts ranged between 82-113% of nominal;

- C18-α-sulfo, 1-methyl esters, monosodium salts ranged between 89-117% of nominal. 

As multiple components of the test substance were measured, nominal concentrations were used for calculation and reporting of results, with measured concentrations for each individual component presented separately.

No significant difference in survival of P0 generation D. magna was found between the control and all the exposure concentrations. One mortality was observed in the nominal 0.09 mg a.i./L concentration on day 8 and in one of the replicates of exposure treatment was observed to be paler than the control and 8 aborted eggs were observed in the test vessel. In the nominal 0.43 mg a.i./L concentration, one mortality was observed on day 6. A further two mortalities were observed over days 13 and 14, resulting in 30% mortality in the exposure concentration by study end. One mortality was observed in the nominal concentration 0.90 mg a.i./L on Day 6 followed by one further mortality on Day 13. The nominal concentration of 2.0 mg a.i./L had one mortality on each of days 9 and 19.

The results obtained from the survival analysis, based on nominal concentrations, are as follows:

NOEC ≥ 2.0 mg a.i./L; LOEC > 2.0 mg a.i./L; EC50 > 2.0 mg a.i./L; EC20 = 0.388 mg a.i./L; 95 % confidence limits = 0.286 mg a.i./L - N.D

The P0 D. magna in all nominal measured test concentrations released their first offspring between days 7 – 9. In the dilution water control the first offspring were released between days 8 – 9. The surviving D. magna in the dilution water control and nominal 0.09, 0.20, 0.90 and 2.0 mg a.i./L concentrations had at least five broods by the end of the study. The surviving D. magna in nominal 0.09 mg a.i./L concentration had completed four broods by the end of the study. Aborted eggs were visible on the bottom of the vessel Day 12 in one replicate of the nominal 0.90 mg a.i. /L concentration.

The mean number of offspring produced per surviving P0 D. magna at test end in the exposure concentrations ranged from 102 to 132. No statistically significant difference (reduction) in reproduction (p < 0.05) was found between the control and exposure concentrations.

The results obtained from the reproduction analyses, based on nominal concentrations, are as follows:

NOEC ≥ 2.0 mg a.i./L; LOEC > 2.0 mg a.i./L; ECx values not determined

The mean number of offspring produced per P0 D. magna in the start of the test which did not die

accidently or inadvertently during the test ranged from 92 to 119. No statistically significant difference (reduction) in reproduction (p < 0.05) was found between the dilution water control and exposure concentrations.

The results obtained from the reproduction analyses, based on nominal concentrations, are as

follows:

NOEC ≥ 2.0 mg a.i./L; LOEC > 2.0 mg a.i./L; ECx values not determined

The results obtained from the length analyses, based on nominal concentrations, are as follows:

NOEC < 0.09 mg a.i./L; LOEC = 0.09 mg a.i./L; EC50 > 2.0 mg a.i./L; EC20 > 2.0 mg a.i./L

A statistically significant difference in length (reduction) was found between the control and all exposure concentrations, however, due to the lack of dose response observed and the ECx values

were greater than 2 mg a.i./L the results are not considered statistically or biologically reliable.

Taking all biological parameters and assessed endpoints into account, there was no effect observed of the registered substance. The determined 21-d NOEC and LOEC was ≥ 2.0 and > 2.0 mg a.i./L, respectively.

Toxicity to aquatic algae

In a key GLP study performed according to OECD 201 and EU Method C.3 (Handley et al, 1994) the freshwater alga, Desmodesmus subspicatus (previous name Scenedesmus subspicatus) was exposed to five nominal concentrations of test material plus mineral medium as the control for 72 hours under static conditions. Nominal concentrations of test item selected following a range-finding study were 6.25, 12.5, 25, 50 and 100 mg/L. Verification of test item concentration took place at 0 and 72 hours using a spectrophotometric method. Chemical analysis showed that test item concentration declined from 90-100 % of nominal at 0 hours to 59-81 % of nominal at 72 hours. This effect was considered to be due to adsorption of the test material to the glassware and/or the algal cells in the test cultures and, to give a worst case analysis of the data, EC50 values were calculated based on the 72-hour measured concentrations. The EbC50 (72 h) value based on biomass was determined to be 45mg/L and the ErC50 (24-48 h) value based on growth rate was determined to be 42 mg/L. The No Observed Effect Concentration (NOEC) was reported as 15 mg/L.