Tall oil, maleated

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Nov 2014 (study initial date)- July 2015 (study completion date)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Lot no: HD0276RA26

Analytical monitoring:

yes

Details on sampling:

All test solutions were taken from all test solutions at the beginning (0d), immediately prior to the first renewal of the test solution (3 d) and weekly thereafter (9, 21 d).

Vehicle:

no

Details on test solutions:

50 mL dichloromethane were added to the 50.0 mL samples and extracted with vibration for 15 min. Combining the extract and after that the solutions were evaporated to dryness by a rotary evaporator and the residual was re-dissolved by 10.0 mL dichloromethane. 200 µL sample was added wirth 200 µL TBDMS for derivatization and then analysed by the above GC-MS method.

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna not being the first brood progeny, was the test species which were 6 to 24 hours old at the start of the test.

Test type:

semi-static

Water media type:

other: Elendt M7 media is a combination of combined trace elements, macro nutrients stock solutions and combined vitamin stock solution. All solution have been prepared by pure water.

Limit test:

yes

Total exposure duration:

21 d

Hardness:

min 221 mg (CaCO3)/L
max 232 mg (CaCO3)/L

Test temperature:

min 20.5 °C
max 21.5 ° C

pH:

min 7.40
max 7.80

Dissolved oxygen:

min 90%
max 101%

Nominal and measured concentrations:

Based on the results of the range finding test, nominal concentration of 10.0 mg/L was conducted in definitive test.

Details on test conditions:

- Light: 16 hour light and 8 hour dark cycle daily (light intensity:1000 lux to 1500 lux)
- Feeding: Chlorella vulgaris Beji was given once every day, 0.1 - 0.2 mg C/Daphnia each time
- Aeration : none

Reference substance (positive control):

no

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

> 10 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Details on results:

The analytical results showed that the analysed concentrations are consistent in the test medium throughout the test period (deviation within 20% of the initial concentration). Thus, a semi static method of 72 h renewal test procedure was reasonable.
During the test all animals in the blank control and solvent control were alive and the number of live offspring produced per parent animal surviving at the end of the test was 64 - 79. The coefficient of variation around the mean number of living offspring produced per parent animal in the controls was 7.06% (<25%). At the end of the test period, no adults died in blank control, solvent control and 10.0 mg/L treatments. Thus, the LOEC of the survival of adults was more than 10.0 mg/L (the measured concentration 8.62 mg/L) and the NOEC was 10.0 mg/L (the measured concentration 8.62 mg/L).
According to independet Samples T test analysis (SPSS 17.0) results of the test data, the significance level of p was more than 0.05. Thus, the reproduction rates in the treatments of 10.0 mg/L concentration treatments showed no significantly different from that of of the solvent control (p > 0.05). Thus, the LOEC for the Daphnia reproduction was more than 10.0 mg/L (the measured concentration 8.62 mg/L) and the NOEC was 10.0 mg/L (the measured concentration 8.62 mg/L).

Validity criteria fulfilled:

yes

Conclusions:

Under valid semi-static conditions (72 h renewal) , for the Dphnia reproduction the LOEC was more than 10.0 mg/L (the measured concentration 8.62 mg/L), the NOEC was 10.0 mg/L (the measured concentration 8.62 mg/L). For survival of adults the LOEC was more thank 10.0 mg/L (the measured concentration 8.62 mg/L), the NOEC was 10.0 mg/L (the measured concentration 8.62 mg/L).

Executive summary:

Under semi-static conditions of 72h renewal, the effect on the reproductive output of Daphnia magna exposed to the test substance (tall oil, maleated) for 21 days was conducted according to "The guidelines for the testing of chemical effects on biotic systems" (HJ/T 153): "The Guideline for the testing of chemicals " (the 2nd edition, 2013); Procedure 211 of the Daphnia magna, Reproduction test", OECD Guidelines for testing of chemicals, 211, adopted on 2 October 2012.

During the whole test period, the pH values of the control mediums and test media were between 7.40 and 7.80 and the dissolved oxygen (DO) values varied from 90% to 101% of the air saturation at the test temperature, the hardness values varied from 221 to 232 mg (CaCO3)/L and the temperature of the test media was maintained in the range of 20.5 °C to 21.5 °C. All animals in the control were alive and the number of living offspring produced per parent animal surviving at the end of the test was >60. The coefficient of variation around the number of living offspring produced per parent animal in the control(s) was <25%. So the study met the acceptability criteria. Therefore, the test was considered valid.

The concentration of the test substance in the test medium was determined by GC-MS to represent the stability of the test substance in test period. A linear regression equation was obtained with the mean peak squares (A) vs the concentration of the tall oil, maleated (c mg/L): A = 13525c+20484, with good linearity of r²= 0.9973. the results show that linearity for the concentration range of 2.00 mg/L to 100 mg/L is good. Besides, the minimum detection amount of GC.MS is 0.013 mg/L and the minimum detection concentration for water sample is 0.043 mg/L. the analytical results showed that the concentration of the test substance is consistent in the test medium through the test period (deviation within 20% of the initial concentration). Thus, a semi-static method of 72h renewal test procedure was reasonable.

The results showed that under semi-static test conditions (72h renewal), for the daphnia reproduction the lowest observed effect concentration (LOEC) was more than 10.0 mg/L (the measured concentration 8.62 mg/L), the no observed effect concentration (NOEC) was 10.0 mg/L (the measured concentration 8.62 mg/L). For survival of adults the LOEC was more than 10.0 mg/L (the measured concentration 8.62 mg/L), the NOEC was 10.0 mg/L (the measured concentration 8.62 mg/L)

Description of key information

LOEC (Reproduction): >10.0 mg/L (the measured concentration 8.62 mg/L)

NOEC (Reproduction): 10.0 mg/L (the measured concentration 8.62 mg/L)

LOEC (Survival): >10.0 mg/L (the measured concentration 8.62 mg/L)

NOEC (Survival): 10.0 mg/L (the measured concentration 8.62 mg/L)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

10 mg/L