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

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

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:

21 d

Dose descriptor:

NOELR

Remarks:

loading of the water accomodated fraction

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: Montan wax Type S

Validity criteria fulfilled:

yes

Conclusions:

Following (no)effect concentrations (nominal, water accommodated fractions WAF) were determined: EC50 (21 days, adult mortality & reproduction) > 100 mg/L; NOEC (21 days, adult mortality & reproduction) ≥ 100 mg/L.

Executive summary:

The studies used as source investigated long-term toxicity towards aquatic invertebrates. 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 reliable studies (reliability category 1) performed on Montan waxes, type S and type WE 40, no biologically relevant toxicity was observed with water accommodated fractions (saturated solutions) prepared at nominal concentrations up to 100 mg/L.

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

EC50 or NOEC for freshwater invertebrates > water solubility limit (OECD 211, 2010 / 2013)

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'. 

Montan waxes, type S was tested in a reliable (category 1) OECD 211 (2008) test (Daphnia magna Reproduction Test). The study was performed compliant to GLP meeting the validity criteria of the OECD-guideline. Semi-static test design (renewal 3 times per week) was applied. The poor solubility of the test item precluded the analytical quantification of the test item in the saturated solution prepared at the nominal limit concentration of 100 mg/L test item (water accommodated fraction). Assessed endpoints were reproduction capacity and other test item-related effects, including occurrence of aborted eggs and stillborn juveniles, time of production of first brood, adult mortality, intrinsic rate of natural increase, dry body weight and length of the parental daphnids. No toxicity was observed in regard to any of the endpoints investigated at a nominal concentration well above the solubility limit.

Montan waxes, type WE 40 was tested in a reliable (category 1) OECD 211 (2012) test (Daphnia magna Reproduction Test). The study was performed compliant to GLP meeting the validity criteria of the OECD-guideline. Semi-static test design (renewal 3 times per week) was applied. The poor solubility of the test item precluded the analytical quantification of the test item at the nominal test item concentrations 6.75, 12.5, 25, 50 and 100 mg/L (water accommodated fractions; DOC-values were near or below the lower detection limit of the total carbon analyser). Assessed endpoints were reproduction capacity and other test item-related effects, including time of production of first brood, adult mortality and length of the parental daphnids. No parental mortality was observed. At all concentrations tested a low reduction of cumulative offspring per Daphnia (3.2% to 13%) was detected, however a concentration-effect relationship was lacking and no valid EC10 could be calculated. Because of a lacking dose-response relationship in accordance with REACH guidance document R.10 the NOEC calculated according to standard statistical analysis is not regarded to be valid. Rather, based on the fact that biologically relevant effects could not be observed, the NOEC was specified as the highest tested nominal concentration (water accommodated fraction). Thus, the following (no)effect concentrations (nominal, water accommodated fractions WAF) were determined: EC50 (21 days, adult mortality & reproduction) > 100 mg/L; NOEC (21 days, adult mortality & reproduction) ≥ 100 mg/L.

Therefore, Montan waxes category members are concluded to be chronically non-toxic to invertebrates.