Reaction products of petrolatum (petroleum), oxidized, esterified with methanol

Endpoint summary

Description of key information

Fish

 

Key study: The 96-Hour LL50 of an analogue test material (EC 265-205-1) 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.

 

Supporting study: Under the conditions of the study, the LL50 of an analogue test material (EC 271-638-7) was determined to be 3540 mg/L with 95 % confidence limits of 2500 - 5000 mg/L.

 

Aquatic invertebrates

 

Key study: The LL50 of an analogue test material (EC 265-205-1) was determined to be 7070 mg/L with 95 % confidence limits of 5000 - 10000 mg/L (OECD 202 and EU Method C.2).

 

Supporting study: The LL50 of an analogue test material (EC 271-638-7) was determined to be 7070 mg/L with 95 % confidence limits of 5000 - 10000 mg/L (OECD 202).

Algae

 

Key study: Exposure to an analogue test material (EC 265-205-1) gave EL50 values of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF (OECD 201 and EU Method C.3).

 

Supporting study: The EL50 of an analogue test material (EC 271-638-7) based on growth rate was determined to be 3860 mg/L while the NOEC was determined to be 1250 mg/L (OECD 201).

 

Microorganisms

 

Key study: Exposure to an analogue test substance (EC 265-205-1) gave an EC50 value > 1000 mg/L and the NOEL was shown to be 1000 mg/L (OECD 209).

Additional information

Fish

 

Key study:In a GLP compliant study performed on an analogue substance (EC 265-205-1) according to the standardised guidelines OECD 203 and Method C.1 of Commission Regulation (EC) No. 440/2008, the toxicity of the test material was determined in a Fish Acute Toxicity Test. Following a preliminary range-finding test, seven fish were exposed to a Water Accommodated Fraction (WAF) of the test item, at a single nominal loading rate of 100 mg/l for a period of 96 hours at a temperature of approximately 14 °C under semi-static test conditions. 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.

Supporting study: The acute toxicity of an analogue test material (EC 271-638-7) 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.

Daphnia magna

 

Key study:A GLP compliant study was performed on an analogue substance (EC 265-205-1) according to the standardised guidelines OECD 202 and Method C.2 of Commission Regulation (EC) No. 440/2008, the toxicity of the test material was determined in a Daphnia Acute Toxicity Test. 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.

Supporting study: In an investigation involving an analogue substance (EC 271-638-7), 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.

Algae

 

Key study:A GLP compliant study was performed on an analogue substance (EC 265-205-1) according to the standardised guidelines OECD 201 and Method C.3 of Commission Regulation (EC) 761/2009 the toxicity of the test material was determined in an Algal Growth Inhibition Test. Due to the low aqueous solubility and complex nature of the test item, for the purposes of the test the test material was prepared as a Water Accommodated Fraction (WAF). Following a preliminary range-finding test, Desmodesmus subspicatus was exposed to a WAF of the test item at a single nominal loading rate of 100 mg/l (six replicate flasks) for 72 hours, under constant illumination and shaking at a temperature of 24 ± 1 °C. Exposure to the test material gave EL50 values of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF. Given that the toxicity cannot be attributed to a single component or a mixture of components but to the test item as a whole the results were based on nominal loading rates only.

Supporting study:An investigation involving an analogue substance (EC 271-638-7), the toxicity of the test material to aquatic plants was investigated in the algae Selenastrum capricornutum in accordance with the standardised guideline OECD 201. During the study, algal cells were exposed to Water Accommodated Fractions (WAF) of test material at 0, 156, 313, 625, 1250, 2500, 5000 and 10000 mg/L. Algal cells were exposed for 72 hours under continuous illumination and cells counts determined by light microscopy. Under the conditions of the test, the EL50 for growth rate was determined to be 3860 mg/L while the NOEC was determined to be 1250 mg/L.

Microorganisms

 

Key study:A GLP compliant study was performed on an analogue substance (EC 265-205-1) according to the standardised guideline OECD 209, the toxicity of the test material was determined in an activated sludge respiration inhibition test. Activated sludge was exposed to the test material for 3 hours at the following concentrations; 10, 100 and 1000 mg/L, after which the rate of respiration was calculated from the oxygen consumption. Under the conditions of the test the EC50was determined to be > 1000 mg/L and the NOEL was shown to be 1000 mg/L. This data was considered sufficient for classification purposes as the toxicity of the test material is beyond the limits of classification according to Regulation (EC) 1272/2008.