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

Short-term toxicity to fish

Description of key information

LL50 of structural analogue >100 mg/l loading rate WAF, rainbow trout, OECD 203, Goodband 2012a

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

Key Study

The potential for a structurally analogous substance to cause acute toxic effects to fish was determined in a GLP compliant study (Goodband, 2012a) performed according to the standardised guidelines OECD 203 and Method C.1 of the Commission Regulation (EC) No. 440/2008. The study was reported in sufficient detail so as to accurately represent the toxicity of the material.

The toxicity of the test material was determined in Oncorhynchus mykiss. Under the conditions of the test, no toxic effects were noted and the 96-Hour LL50 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 fish was investigated in rainbow trout in accordance with the standardised guideline OECD 203. The fish 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 7 fish were exposed to test material at the following concentrations: 0, 625, 1250, 2500, 5000 and 10000 mg/L. Potassium chloride was used as the reference substance.

In the definitive study, no mortalities were observed up to 2500 mg/L. All the fish died at the 5000 and 10000 mg/L dose levels. Under the conditions of the study, the LL50 of the test material was determined to be 3540 mg/L with 95 % confidence limits of 2500 - 5000 mg/L. The LC50 of the reference substance was determined to be 4070 mg/L with 95 % confidence limits of 3590 - 4620 mg/L. The reference substance results indicate that test reproducibility and sensitivity of the organisms were within established limits.

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, 96 h LL50 >100 mg/L loading rate WAF, was taken forward for risk assessment.