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

Toxicity to microorganisms

Link to relevant study record(s)

Reference

Endpoint:

activated sludge respiration inhibition testing

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Justification for type of information:

For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.

Reason / purpose for cross-reference:

assessment report

Key result

Duration:

3 h

Dose descriptor:

EC10

Effect conc.:

> 10 g/L

Nominal / measured:

nominal

Conc. based on:

test mat. (total fraction)

Basis for effect:

inhibition of total respiration

Remarks on result:

other: Montan wax Type E

Remarks:

limit test, due to the low solubility of the test item

Key result

Duration:

3 h

Dose descriptor:

EC10

Effect conc.:

> 10 g/L

Nominal / measured:

nominal

Conc. based on:

test mat. (total fraction)

Basis for effect:

inhibition of total respiration

Remarks on result:

other: Montan wax Type S

Remarks:

limit test, due to the low solubility of the test item

Key result

Duration:

3 h

Dose descriptor:

EC10

Effect conc.:

> 10 g/L

Nominal / measured:

nominal

Conc. based on:

test mat. (total fraction)

Basis for effect:

inhibition of total respiration

Remarks on result:

other: Montan wax Type OP

Remarks:

limit test, due to the low solubility of the test item

Validity criteria fulfilled:

yes

Conclusions:

No toxicity was observed in regard to activated sludge respiration rates (3 hours exposure time) at nominal limit concentrations of 1000 mg/L or 10000 mg/L with any of the Montan waxes types tested.

Executive summary:

The studies used as source investigated adverse effects on activated sludge respiration rates. The study results of the source compound were considered applicable to the target compound and were used for classification and labelling acc. to REGULATION (EC) No 1272/2008. Justification and applicability of the read-across approach (category approach) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.

Description of key information

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 S, E and OP).

EC10/LC10 or NOEC for aquatic micro-organisms ≥ 1000 mg/L (OECD 209, 2003 / 2012)

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'.

Reliable (category 1 for types WE 40 and NaV 101, reliability category 2 for types S, E and OP) OECD 209 tests (Activated Sludge Respiration Inhibition) were performed compliant to GLP and meeting the validity criteria of the OECD-guideline. No toxicity was observed in regard to respiration rates (3 hours exposure time) at applied nominal limit concentrations of 1000 mg/L (types WE 40 and NAV 101) or 10,000 mg/L (types W, E and OP) with any of the Montan waxes types tested. Therefore, members of the Montan waxes category are concluded to be non-toxic to sewage sludge microorganisms.