Registration Dossier

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Short-term toxicity to fish

The toxicity of KMPS triple salt to aquatic organisms was tested in three short term toxicity test to fish. To Rainbow Trout in a semi static test according to OECD 203, to the marine species Sheepshead minnows according to the US EPA guideline 850.1075. and to the Zebra fish in a semi static test also according to the OECD Guideline 203.

The acute toxicity test in rainbow trout was performed according to OECD 203 without deviations. Fish were exposed for 96 h to 5 different concentrations. The LC 50 was calculated to be 53 mg/L. The acute toxicity of KMPS triple salt to Sheepshead minnows was determined in a static dose-response 96-h test according to the US EPA guideline 850.1075. with an LC 50 of 1.09 mg/L. An acute toxicity test in Brachydanio rerio was performed according to OECD 203 under semi-static conditions. Fish were exposed for 96 h to 6 different concentrations in order to derive a LC50. The test medium was daily renewed. The 48- and 96h LC50 were both found to be 42.3 mg/L.

Long-term toxicity to fish

The study assessing the potential effects of KMPS triple salt on Sheepshead minnow embryos and fry during an early life-stage exposure was performed according to the US EPA guideline 850.1400.

Due to the limitations of the analytical method, the monitoring of the test substance concentration was not performed. However, stock solutions were analysed. Results are based on nominal concentrations.

Hatching success in the control was 89% and ranged from 85 to 93% in the test item treatments without significant differences to the control. Post hatch survival of fry in the control was 97% and ranged from 2 to 96% in the treatments, with significant effects in the highest concentration. Blotted wet weight was significantly reduced at 444 and 889 µg/L, while mean length was not significantly different compared to the control.

NOEC = 222 µg KMPS triple salt/L blotted wet weight

LOEC = 444 µg KMPS triple salt/L blotted wet weight

Short-term toxicity to aquatic invertebrates

Short term toxicity of KMPS triple salt to aquatic invertebrates was tested in two key studies and one supporting study. The acute toxicity test to Daphnia magna according to the EU Guideline C2 and the OECD 202 was tested in a semi static test. The acute toxicity of KMPS triple salt to Mysid shrimp was determined in a semistatic dose-response 96-h test according to the US EPA guideline 850.1035. The acute toxicity of Caroat to Daphnia magna was determined in a static-test system according to the OECD Guideline No. 202, with an exposure period of 24 h.

The acute toxicity test in Daphnia magna was performed according to EU Guideline C2 and the OECD 202 without deviations. Daphnids were exposed for 48 h to 5 different concentrations in order to derive an EC 50 of 3.5 mg/L

The acute toxicity of KMPS triple salt to Mysid shrimp was determined in a semistatic dose-response 96-h test according to the US EPA guideline 850.1035. The 96-h LC50 was determined to be 1180 µg KMPS triple salt/L with a confidence interval of 1070 - 1290 µg KMPS triple salt/L.

The acute toxicity of Caroat to Daphnia magna was determined in a static-test system according to the OECD Guideline No. 202, with an exposure period of 24 h. The calculated EC 50 was 5.3 mg/L.

Long term toxicity to aquatic invertebrates

The potential of KMPS triple salt for acute and chronic effects on saltwater mysids (Americamysis bahia) exposed for 28 days in a life-cycle test was investigated according to the US EPA guideline no. 850.1350 under flow-through conditions. Toxicological endpoints were survival, growth and reproduction.

After 28 days of exposure mean survival of the first generation mysids were 93, 95, 98, 99, 92 and 0% in the control, 33.3, 66.7, 133, 267 and 533 µg KMPS triple salt/L treatments, respectively, with statistically significant reduction at the highest concentration. The 96-h survival of juvenile mysids was not statistically significant different compared to the control in all treatments. The total young per female was not statistically significant different from the control at any treatment. The second brood was not statistically significant compared to the control.

NOEC = 267 µg KMPS triple salt/L adult and juvenile survival, adult body length, offspring per female

LOEC = 533 µg KMPS triple salt/L adult survival, > 267 µg KMPS triple salt/L juvenile survival, adult body length, offspring per female

EC50 (adult survival) = 367 µg KMPS triple salt/L with a 95% confidence interval of 358 to 378 µg KMPS/L

Toxicity to aquatic algae and cyanobacteria

The acute toxicity of KMPS triple salt to aquatic algae was tested in two key studies. One acute toxicity test was performed according to the EU Guideline C.3 and to the OECD 201. The second test was performed according to the US EPA guideline 850.5400, 1996.

The acute toxicity test in algae was performed according to the EU C.3 and OECD 201 Guidelines without deviations. The test system was static and Selenastrum capricornutum was used as test organism. Algae were exposed for 72 h to 5 different concentrations in order to derive an EC50. The EC50 for growth rate was calculated to be ErC50(0-72 hours) > 1.0 mg/L.

The acute toxicity of KMPS triple salt to the marine diatom was determined in a static dose-response 96-h test according to the US EPA guideline 850.5400, 1996. The EC50 for growth rate was determined to be 0.556 mg/L with a NOEC for growth rate of 0.444 mg/L.

Toxicity to microorganisms

For the determination of the toxicity to microorganisms a key and a supporting study are available. The key study was conducted according to the OECD Guideline 209. In the supporting study the toxicity of KMPS triple salt to the gram negative bacterium Pseudomonas putida was determined in a growth inhibition test according to the guideline of the German Umweltbundesamt: "Bewertung wassergefährdender Stoffe: Bestimmung der akuten Bakterientoxizität".

In the key study activated sludge from Eye Sewage Treatment Works for the treatment of domestic sewage was used. The test revealed an EC20, EC50 and an EC80 of more than 100 mg/L. In the toxicity test of KMPS triple salt to the gram negative bacterium Pseudomonas putida an EC50 of 179 mg/L was calculated.

Classification and Labelling

Based on aquatic toxicity test results obtained, KMPS (triple salt) is classified and labelled as R 52 according to Directive 67/548/EC (DSD) and not classified according to Regulation 1272/2008/EC (CLP).

Justification

The acute toxicity tests in algae and diatoms were performed according to guideline OECD 201, without deviations. The test systems were static and Selenastrum capricornutum (freshwater) and Skeletonema costatum (marine) were used as test organisms. Algae and diatoms were exposed for 72 h to 5 different concentrations in order to derive EC50-values. It is important to note that the marine test is likely to overestimate the toxicity to KMPS, because in salt water oxidation of KMPS generates chlorine from sodium chloride, increasing the biocidal activity of test solutions. Further, as results obtained from these exponential test systems cannot be used without logarithmic transformation, only growth rate ErC50-values are relevant (TGD, 2003). Based on the behaviour of KMPS in sea water and the marginal ErC50-values obtained (> 1 mg/L), classification and labelling with N, R50 or Acute env. tox. cat. 1, H400, according to Directive 67/548/EC (DSD) and Regulation 1272/2008/EC (CLP), respectively, do not apply.

The 96 hour LC50for rainbow trout of 53 mg/l qualifies for R52 (harmful to aquatic organisms) and the Daphnia 48 hour EC50of 3.5 mg/l suggests that R51 should be applied, according to Directive 67/548/EC (DSD). However, KMPS readily decomposes in natural environments and does require the R53 risk phrase. Hence R50 is not required and since R51 is not used by itself, but only in the combination R51/R53 (which is not scientifically justified), R52 applies. According to Regulation 1272/2008/EC (CLP), KMPS is not classified for acture environmental toxicity. Based on the fact that the substance is considered rapidly degradable and chronic data is available for all three trophic levels, with the most stringent outcome of a 37-day NOEC in Cyprinodon variegatus of 0.222 mg/L, a Cat 3 (H412: harmful to aquatic life with long lasting effects) is warranted according to Regulation 1272/2008/EC (CLP) and ATP 02.