Soybean oil, maleated, ester with triethanolamine

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0.036 mg/L

Assessment factor:

1 000

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

0.36 mg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.004 mg/L

Assessment factor:

10 000

Extrapolation method:

assessment factor

PNEC marine water (intermittent releases):

0.036 mg/L

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

100 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

1 537.33 mg/kg sediment dw

Extrapolation method:

assessment factor

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

153.73 mg/kg sediment dw

Extrapolation method:

assessment factor

Hazard for air

Air

Hazard assessment conclusion:

no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:

PNEC soil

PNEC value:

306.54 mg/kg soil dw

Extrapolation method:

assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

PNEC oral

PNEC value:

66.67 mg/kg food

Assessment factor:

300

Additional information

Due to the low solubility and complex nature of the test item, for test media for investigations of short-term aquatic toxicity were prepared as a Water Accommodated Fractions (WAFs). Given that the toxicity cannot be attributed to a single component or a mixture of components, but to the test item as a whole, results were based on nominal loading rates.

Conclusion on classification

The test substance is not clas sified for human health

The acute toxicity of the test item to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated and gave a 96-Hour LL50 value of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading rate was 100 mg/L loading rate WAF.

The effect of the test item on the growth of Pseudokirchneriella subcapitata has been investigated over a 72-Hour period and gave the following results:

 

Response Variable           EL 50                                  No Observed Effect      Lowest Observed Effect

(mg/L Loading Rate WAF)            Loading Rate (NOEL)     Loading Rate (LOEL) (mg/L)

Growth Rate                              60                                                    12.5                                                               40

Yield                                          33                                                    12.5                                                               40

 

The effect of the test item on the respiration of activated sewage sludge micro-organisms gave a 3-Hour EC50 value of greater than 1000 mg/L. The No Observed Effect Concentration (NOEC) after 3 hours exposure was 1000 mg/L.

 

Exposure of the freshwater invertebrate Daphnia magna to the test item has been investigated and gave the following results:

 

Time Point          EL50                     95% Confidence Limits                                 NOEL   LOEL

(Hours)               (mg/L LR WAF)        (mg/L LR WAF)                                          (mg/L)  (mg/L)

48                          36                         25          -             53                                         3.2          10

 

The ready biodegradability of the test item was assessed in accordance with OECD Guideline 301B.  The test item attained 19% biodegradation after 28 days and therefore cannot be considered to be readily biodegradable under the strict terms and conditions of OECD Guideline No. 301B.

Systemic distribution of the substance can be predicted from the physical chemical properties of this substance. The very high LogPow and modest water solubility of the substance, suggests that this substance, upon systemic absorption, may be transported through the circulatory system both in association with a carrier molecule such as a lipoprotein or other macromolecules. The major proportion of the substance will not readily traverse cellular barriers or distribute into fatty tissues. There is no evidence of systemic toxicity and/or histopathological changes or increasing severity of clinical observations from repeated dose studies, nor of cumulative toxicity, as would be manifested by an accumulation of the substance or its’ metabolites in body tissues