Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 toxicity of the registered substance to fish ( zebrafish) was determined according to OECD-Guideline for Testing of Chemicals No. 203 ( 1992). A static limit test with a water accommodated fraction was conducted. The preparation method has been chosen with regard to the test item properties and in accordance with the relevant OECD guidance document (2000). Duration of the test was 96 h. Seven fish were exposed to the water accommodated fraction and the control. Water quality parameters pH-value, temperature and oxygen-saturation measured after 0, 24, 48, 72 and 96 h were determined to be within the acceptable limits. Specific test item analysis of the test media was carried out via GC-MS. Effects are given as nominal loading level (LL). As no mortality was observed at a loading level of 4 mg/L, the NOEL (no observed effect loading) as well as the LL50 are greater than 4 mg/L (Cognis, 2006).

Long-term toxicity to fish:

Long-term toxicity to fish was waived. In Annex IX of Regulation (EC) No 1907/2006, it is laid down that chronic toxicity tests shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on fish. According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as dangerous according to Directive 67/548/EEC or Directive 1999/45/EC or is assessed to be a PBT or vPvB. The hazard assessment reveals neither a need to classify the substance as dangerous to the environment, nor that it is a PBT or vPvB substance, nor that there are any further indications that the substance may be hazardous to the environment. Therefore, and for reasons of animal welfare, a long-term toxicity study in fish is not provided.

Short-term toxicity to aquatic invertebrates:

The Acute Immobilisation of the registered substance to Daphnia magna (STRAUS) was determined according to OECD Guideline 202 (2004). The study was conducted with 6 loading levels of the water accomodated fraction ranging from 0.625 to 20.0 mg/L in a geometric series with a dilution factor of 2 under static conditions over a period of 48 h. All loading levels and the control were analytically verified via GC-MS after 0 h (new media) and 48 h (old media). All effect values are given based on the loading levels of the water accommodated fraction.

The EL10- and EL50-values after 24 and 48 h were calculated by sigmoidal dose-response regression. A reference test was carried out with potassium dichromate as reference item. The EC50-value of the reference item at 1.67 mg/L after 24 h was within the prescribed concentration range of 1.0 - 2.5 mg/L according to AQS P 9/2 (05/1996) for daphnids clone 5 cultured in Elendt M4 medium (DIN 38412 - L 30). Water quality parameters pH-value and dissolved oxygen concentration were determined to be within the acceptable limits. The validity criteria of the test guideline were fulfilled. The EL50 (48h) was determined as 4.01 mg/L (Cognis, 2006). However, the determined EL50 is far above the solubility limit of the substance. Therefore, this result is considert not relevant for classification.

Toxicity to aquatic algae and cyanobacteria:

The toxicity of the regsistered substance to the unicellular freshwater green alga Desmodesmus subspicatus was determined according to the principles of OECD 201. The aim of the study was to assess the effects on growth rate and biomass production over a period of 72 h. The study was conducted under static conditions with an initial cell density of nominally 10E03 - 10E04 cells/mL. Based on the results of a range-finding test, the study was conducted as a limit test with the water accommodated fraction (WAF, 100 mg/L). Per definition of the WAF all terms related to concentration levels were given as loading levels because partly dissolved compounds and mixtures cannot be related to concentrations. Six replicates were tested for the test item WAF and control. Environmental conditions were determined to be within the acceptable limits. The loading of the test substance was analysed at test start and test end via GC-MS. All effect values are given based on the nominal loading levels of the test item. The registered substance did not show any (growth rate and biomass) algae toxicity at the loading level of 100 mg/L (Cognis, 2006).

Toxicity to microorganisms:

The effect of the registered substance on the respiration rate of an activated sludge according to the OECD guideline 209 after an incubation duration of three hours was investigated. Due to the low water solubility of the test substance, a WAF (water accommodated fraction) was used for testing. As inoculum microorganisms from a sewage treatment plant mainly fed with municipal wastewater were used. The respiration rate of the activated sludge incubated with the WAF of the registereed substance was found to be 25.4 mg 02/(L*h) after three hours. Thus the respiration rate of the assay containing the substance was in the range of the control assays of 21.1 — 23.8 mg 02/(L*h). There was no inhibitory effect of the test item on the respiration rate. The EC50 of the reference item 3,5-dichlorophenol for respiration inhibition was between 5 and 17.5 mg/I. The validity criterions concerning the reference item and the comparability of the controls were fulfilled. No important oxygen consumption by the registered substance was detected after three hours. On the basis of this result, the registered substance in a nominal concentration of 100 mg/L causes no inhibition of the respiration rate of an activated sludge in a respiration inhibition test (Cognis, 2006)