Hydrocarbon waxes (petroleum), oxidized, Me esters, calcium salts

Short-term toxicity to aquatic invertebrates

Description of key information

48 hour LL50 >100 mg/L loading rate WAF, Daphnia magna, OECD 202, Goodband 2012b

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

Key Study

The potential for a structurally analogous substance to cause acute toxic effects to aquatic invertebrates was determined in a GLP compliant study (Goodband, 2012b) performed according to the standardised guidelines OECD 202 and Method C.2 of the Commission Regulation (EC) No. 440/2008. The study was reported in sufficient detail to provide an accurate assessment of the results and study quality, and to accurately represent the toxicity of the material. 

Following a preliminary range-finding test, twenty daphnids were exposed to Water Accommodated Fractions (WAFs) of the test material, over a range of nominal loading rates of 1.0, 1.8, 3.2, 5.6, 8.0, 18, 32, 56 and 100 mg/l for a period of 48 hours at a temperature of approximately 21 °C under static test conditions.

The 48-Hour EL50 based on nominal loading rates was greater than 100 mg/l loading rate WAF. The No Observed Effect Loading rate was 100 mg/l loading rate WAF.

The study was performed to a good standard and was assigned a reliability score of 2 using the principles for assessing data quality as set out in Klimisch (1997) as a result of the data being used in a read across capacity. Read across is justified on the basis of similar chemical structures and analogous results from a batch of physico-chemical tests, including water solubility.

 

Supporting Information

The acute toxicity of the test material to aquatic invertebrates was investigated in Daphnia magna in accordance with the standardised guideline OECD 202. The Daphnia were exposed to a Water Accommodated Fraction (WAF) of test material which was prepared according to a modified ASTM method. Following a preliminary study, groups of 5 daphnia were exposed to test material at the following concentrations: 0, 625, 1250, 2500, 5000 and 10000 mg/L (as WAF). Sodium chloride was used as the reference substance. In the definitive study, no mortalities were observed up to 2500 mg/L. Two daphnia dosed at 5000 mg/L WAF were found dead/immobilised after 24 hours in replicate A. All daphnia dosed at 10000 mg/L WAF were found dead/immobilised after 48 hours in all replicates. Under the conditions of the study, the LL50 of the test material was determined to be 7070 mg/L with 95 % confidence limits of 5000 - 10000 mg/L.

The non-GLP study was performed in line with an accepted standardised guideline with a sufficient level of reporting to assess the quality of the relevant results. The study was assigned a reliability score of 2 and considered suitable for assessment as an accurate reflection of the test material. However, it was deemed more appropriate to select the more reliable study conducted on a structural analogue as the key data to be used.

 

The available data are considered to be complete and the result determined, 48 h LL50 value of >100 mg/L loading rate WAF, was taken forward for risk assessment.