Reaction mass of Fatty acids, montan-wax and Fatty acids, montan-wax, ethylene esters and Fatty acids, montan wax, mixed esters with fatty acids C16-18 and ethylene glycol and Fatty acids, montan-wax, stearyl esters and Montan wax

Endpoint summary

Description of key information

Key values for acute aquatic toxicity

Fish: 96h-LC50 > water solubility limit

Daphnids: 48h-EC50 > water solubility limit

Algae: 72h-EC50 > water solubility limit

Key value for chronic aquatic toxicity

Fish: Data waiving according to column 2 of REACH Annex IX

Daphnids: 21d-NOEC > water solubility limit

Algae: 72h-NOEC > water solubility limit

Key value for toxicity to microorganisms

3h-EC50 (activated sludge microorganisms, respiration) >= 1000 mg/L

3h-EC10 (activated sludge microorganisms, respiration) >= 1000 mg/L

Additional information

Please refer to CSR for further details on study summaries of different members of the Montan waxes category as well as Read-across justification in section 13 'assessment reports'.

 

Acute aquatic toxicity

Four reliable 96-hour acute toxicity studies (RL 1) on fish with Montan waxes types NaV 101, WE 4, CaV 102 and type E were performed according to OECD 203, compliant to GLP and meeting the validity criteria of the OECD 203 (1992) guideline. No toxicity was found with any of these substances at nominal concentrations well above the solubility limit (100 mg/L to 10 g/L upper nominal test item concentrations, depending on the study). Therefore, the LC50 for freshwater fish is > water solubility limit.

In five reliable studies (RL 1) with Montan waxes types NaV 101, WE 4, CaV 102, type E and type LG no biologically relevant toxicity to Daphnia magna was observed using water accommodated fractions with nominal loading rates up to the limit concentration of 100 mg/L recommended by the OECD 202 guideline. Therefore, the EC50 for aquatic invertebrates is > water solubility limit.

Montan waxes, types LG, KPS, WM 31, O, NaV 101, S, E, and OP were tested in reliable (RL1) OECD 201 tests with the unicellular freshwater green alga Desmodesmus subspicatus or Pseudokirchneriella subcapitata. All studies were performed compliant to GLP and meeting the validity criteria of the OECD guideline. No inhibition of growth was observed with any of the Montan waxes types tested at nominal concentrations well above their solubility limits. Therefore, Montan waxes category members are concluded to be acutely non-toxic to aquatic plants / alga. The EC50 for freshwater algae is > water solubility limit.

In conclusion, no acute hazard for the aquatic environment is anticipated.

 

Chronic aquatic toxicity

Note, chronic data is included because of the low water solubility of the submission substance.

Montan waxes, type S and WE40 were tested in reliable (category 1) OECD 211 tests (Daphnia magna Reproduction Test). The studies were performed compliant to GLP meeting the validity criteria of the OECD-guideline. No toxicity was observed in regard to any of relevant endpoints investigated at a nominal concentration well above the solubility limit (100 mg/L).The EC50 or NOEC for freshwater invertebrates is > water solubility limit.

Montan waxes, types LG, KPS, WM 31, O, NaV 101, S, E, and OP were tested in reliable (reliability category 1) OECD 201 tests with the unicellular freshwater green alga Desmodesmus subspicatusor or Pseudokirchneriella subcapitata. All studies were performed compliant to GLP and meeting the validity criteria of the OECD guideline. No inhibition of growth was observed with any of the Montan waxes types tested at nominal concentrations well above their solubility limits. Therefore, Montan waxes category members are concluded to be chronically non-toxic to aquatic plants / alga. Therefore, EC10/LC10 or NOEC for freshwater algae > water solubility limit.

In conclusion, no chronic hazard for aquatic organisms is anticipated.

 

Toxicity to microorganisms

In five reliable studies (two RL 1, three RL 2) with different members of the Montan waxes category, no signs of toxicity were observed at the nominal limit concentrations of 1000 mg/L (types WE 40 and NAV 101) and 10,000 mg/L (types W, E and OP). The tests were performed according to OECD 209 tests (Activated Sludge Respiration Inhibition) and compliant to GLP meeting the validity criteria of the OECD-guideline. Therefore, EC10/LC10 or NOEC for aquatic micro-organisms is ≥ 1000 mg/L.

No hazard for STP microorganisms is anticipated well above the water solubility of the submission substance.