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Short-term toxicity to fish

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short-term toxicity to fish
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
96 h
Dose descriptor:
Effect conc.:
> 10 g/L
Nominal / measured:
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: Montan wax Type E
WAF prepared at 10 g/L loading level
Validity criteria fulfilled:
No toxicity was found with any of the tested 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).
Executive summary:

The studies used as source investigated acute toxicity to fish. 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 four reliable studies (reliability category 1) with different members of the Montan waxes category, no signs of toxicity were observed in limit tests using saturated solutions.

LC50 for freshwater fish > water solubility limit (OECD 203, 1997 / 2002 / 2012)

Key value for chemical safety assessment

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 96-hour acute toxicity studies (RL 1) on Zebrafish 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. Static test design was applied.The very poor solubility of the test items precluded the analytical quantification of the test item in the saturated solutions (close to or below limit of quantification) and water accommodated fractions were tested with the exception of the study on Montan waxes, type E where the test item was directly added to the test basins. 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).

For Montan wax type NaV 101 two further 96 hour studies on Zebrafish (static design) are available, which were judged unreliable (RL 3) due to methodological deficiencies.

In the first one, Montan wax type NaV 101 was tested at a nominal limit concentration of 500 mg/L (no filtration). Due to the poor solubility of the test item, floating material and precipitation was observed. Measured concentrations in water declined during the study. No mortalities were observed during the test and behavioural abnormalities at 24 hours in the concentration group were reversible (no symptoms at 48 to 96 hours).

In another test, using filtered solutions prepared at nominal concentrations between 10 and 1000 mg/L, an LC50(96 h) of 87 mg/L was determined as the geometric mean of LC0(75 mg/L) and LC100(100 mg/L). The study is insufficiently documented. Especially no data on appearance of test solutions during the test are provided (e.g. on precipitation and turbidity) and no data on behaviour or appearance of fish is given; reporting of effects is restricted to mortality. The validity criterion to keep the oxygen concentration at least at 60% of air saturation level was not met at the highest test item concentration and only barely at the 100 mg/L level. The steep increase of the concentration-effect curve (0% mortality at 75 mg/L, 100% mortality at 100 mg/L) is surprising. An influence of increased pH cannot be excluded: pH increased from pH 8.3 at 75 mg/L to 8.7 at 100 and 9.5 at 1000 mg/L. Ammonia toxicity is known to increase with pH due to de-ionization especially above pH 8, and density of fish in test basins is not reported. Taken together, the study is judged unreliable (RL 3).

Due to the conflicting results of these two older, unreliable studies a new guideline-compliant study was performed with Montan wax type NaV 101, demonstrating absence of toxicity to Zebrafish using a saturated solution prepared at 100 mg/L (water accommodated fraction) as summarized above.

Concluding from the results of four available reliable studies, Montan waxes category members can be regardedas acutely non-toxic to freshwater fish.

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