Reaction mass of bis(2-ethylhexyl) terephthalate, butyl 2-ethylhexyl terephthalate, and dibutyl terephthalate

Toxicity to soil macroorganisms except arthropods

Link to relevant study record(s)

Reference

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was conducted between 1 August 2016 and 31 August 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

Chemical Name: 1,4-Benzenedicarboxylic acid, mixed Bu and 2-ethylhexyl diester
CAS: 1571954-81-8（A：1962-75-0，B：1429441-82-6，C：6422-86-2）
Molecular formula: A: C16H22O4; B: C20H30O4; C: C24H38O4
Molecular weight: A: 278; B: 334 ; C: 390
Purity: 99.8%
Water solubility: 2.19 mg/L（20°C）
Batch No.: GLFG160607
Expiry date: 2017-06-01
Appearance: Colourless liquid
Storage conditions: Room temperature (25 oC)，no contact with air and light

Analytical monitoring:

no

Vehicle:

yes

Remarks:

Acetone

Details on preparation and application of test substrate:

Test Soil
Artificial soil test substrate was prepared as follows:
a) 10 per cent sphagnum peat (Pindstrup Mosebrug A/S; pH 6.0, no visible plant remains, finely ground, dried).
b) 20 per cent kaolin clay (CAS: 1332-58-7; Lot number: 20150805; Sinopharm Chemical Reagent Co. Ltd.; kaolinite content preferably above 30 per cent).
c) 70 per cent quartz sand (CAS: 14808-60-7; Lot number: 20160309; Sinopharm Chemical Reagent Co. Ltd.; fine sand should be dominant with 80 per cent of the particles between 50 and 200 microns).
The dry constituents were blended in the correct proportions and mixed thoroughly

Preparation of the Test Substrate
(1) Range-finding Test
The stock solution of 100 g/L was prepared by dissolving 5.0015 g test substance into 50.0 mL acetone.
Test substrates at different concentrations were prepared by adding the stock solution to 10g quartz sand and mixed. After evaporating the acetone at the room temperature, 10g quartz sand then mixed with 550g dry weight of soil for each test container. The medium was thoroughly mixed and deionised water was added finally to give an overall moisture content of about 35 per cent of the dry weight.
Simultaneously blank control group and solvent control group were established. The solvent control group was administrated with the maximum amount of acetone in the treatment (1000 mg/kg artificial soil (dry weight)), and the blank control group added none acetone. Details about the preparation of the test substrates at chosen concentrations were given as follows.

Test Type Concentration of the test substance (mg/kg (dry soil)) The amount of liquid reserves (mL) Dry soil (g) Deionised water(mL) Replication
Range-finding test 0 0 560 190 1
0 (Acetone) 0 (5.6 mL Acetone) 560 190 1
100 0.56 560 190 1
500 2.80 560 190 1
1000 5.60 560 190 1

(2) Limited test
The stock solution of 100 g/L was prepared by dissolving 5.0050 g test substance into 50 mL acetone.
Test substrates at different concentrations were prepared by adding the stock solution to 10g quartz sand and mixed. After evaporating the acetone at the room temperature, 10g quartz sand then mixed with 550g dry weight of soil for each test container. The medium was thoroughly mixed and deionised water was added finally to give an overall moisture content of about 35 per cent of the dry weight.
Simultaneously blank control group and solvent control group were established. The solvent control group was administrated with the maximum amount of acetone in the treatment (1000 mg/kg artificial soil (dry weight)), and the blank control group added none acetone. Details about the preparation of the test substrates at chosen concentrations were given as follows.

Test Type Concentration of the test substance (mg/kg (dry soil)) The amount of liquid reserves (mL) Dry soil (g) Deionised water(mL) Replication
Limit test 0 0 560 190 4
0 (Acetone) 0 (5.6 mL Acetone) 560 190 4
1000 5.60 560 190 4

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

Eisenia foetida was adopted as the test species. The worms were obtained from an earthworm nursery of Nanjing city in China.
Name: Nanjing Earthworm Nursery
Adress: Pudong community, Changlu Street, Dachang District, Nanjing

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

yes

Total exposure duration:

14 d

Post exposure observation period:

None

Test temperature:

19.7 to 20.2°C

pH:

Not specified

Moisture:

78 to 82%

Details on test conditions:

During this test, artificial soils was used with the moisture content of the test medium controlled in range of 28% to 35% with pH form 6.32 to 6.56. The test conditions were maintained as follows: temperature of 19.7°C to 20.2°C, humidity of 78% to 82% and continuous light with intensity of 400 lux to 800 lux. No unusual circumstances that might have affected the integrity and quality of the study were observed. Mortality was not observed in the control at the end of the study. Thus, the test system was considered to be valid.

Nominal and measured concentrations:

Based on the results of the range-finding test, a Limited test was undertaken with test concentration of 1000 mg/kg (dry weight of soil)

Reference substance (positive control):

yes

Remarks:

Solvent control (acetone)

Key result

Duration:

7 d

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Key result

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Duration:

14 d

Dose descriptor:

LC0

Effect conc.:

1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

Earthworm Mortality
Number of the dead earthworms after 7 and 14 days is shown in Table 4 and Table 5. No dead worms were observed in treatments, blank controls and solvent controls. The results of the Range-finding test and the Limit Test both showed that the 7 d and 14 d-LC50 to Eisenia foetida in artificial soil were greater than 1000 mg/kg soil dry weight.

Behavioural Effects
At the beginning of the administration, test worms soon disappeared into the test soil medium. During the test, all survival earthworms remained in the soil.

Results with reference substance (positive control):

No dead worms were observed in blank controls and solvent controls

Conclusions:

During this test, artificial soils were used with the moisture content of the test medium controlled in range of 28% to 35% with pH form 6.32 ~ 6.56. The test conditions were maintained as follows: temperature of 19.7°C to 20.2°C humidity of 78% to 82% and continuous light with intensity of 400 lux to 800 lux.

The result indicated that the 7 d LC50 and 14 d LC50 of the test substance (GL500) in the artificial soil were both greater than 1000 mg/kg dry weight soil. The highest concentration causing no mortality for 7 d (7-d LC0) and 14 d (14-d LC0) were 1000 mg/kg dry weight soil.

Executive summary:

The test was conducted to determine the acute toxicity of test substances (GL500) to earthworm according to “The guidelines for the testing of chemicals” (HJ/T 153 -2004) and “The Guidelines for the Testing of Chemicals-Effects on BioticSystems” (the2^ndedition.:Environment Press. 2013); while with reference to Procedure 207 of the ‘Guidelines for Testing of Chemicals’ of the OECD:“Earthworm, Acute Toxicity Tests” (1984)etc.

During this test, the artificial soils was used with the moisture content of the test medium controlled in range of 28% to 35% with pH from 6.32 to 6.56. The test conditions were maintained as follows: temperature of 19.7°C to 20.2°C,humidity of 78% to 82% and continuous light with intensity of 400 lux to 800 lux.

Based on the result of range-finding test and limit test,the7-day and14-day LC₅₀ of the test substance (GL500) in the artificial soil were both determined to be greater than 1000mg/kg dry weight soil. The highest concentration causing no mortality (7-dayand 14-day LC₀) was 1000 mg/kg dry weight soil.

Description of key information

Based on the result of range-finding test and limit test,the7-day and14-dayLC₅₀of the test substance (GL500) in the artificial soil were both determined to be greater than 1000mg/kg dry weight soil. The highest concentration causing no mortality (7-dayand 14-day LC₀) was 1000 mg/kg dry weight soil.

Key value for chemical safety assessment

Short-term EC50 or LC50 for soil macroorganisms:

1 000 mg/kg soil dw

Long-term EC10, LC10 or NOEC for soil macroorganisms:

1 000 mg/kg soil dw