1,4-Benzenedicarboxylic acid, 1,4-diisononyl ester

Toxicity to soil macroorganisms except arthropods

Administrative data

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-01-21 to 2011-03-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

Version / remarks:

(1984)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1,4-Benzenedicarboxylic acid, 1,4-diisononyl ester

EC Number:

700-453-0

Cas Number:

59802-05-0

Molecular formula:

C26H42O4

IUPAC Name:

1,4-Benzenedicarboxylic acid, 1,4-diisononyl ester

Test material form:

liquid

Sampling and analysis

Analytical monitoring:

no

Test substrate

Vehicle:

yes

Remarks:

acetone

Details on preparation and application of test substrate:

- Method of mixing into soil (if used): An aliquot (35 ml) of the 5000 mg/50 mL solvent stock solution was added to approximately 200 g of artificial soil and the solvent allowed to evaporate off prior to incorporation into a final amount of 3.5 kg (dry weight) of artificial soil with 980 ml of deionised reverse osmosis water. This was mixed with a mixer to give the 1000 mg/kg test concentration.
- Controls: The control was prepared in a similar manner, without the addition of solvent or test item. Solvent control (acetone). The control and solvent control soil was dispersed to four replicates and the test soil was dispersed to six replicates.
- Chemical name of vehicle: acetone
- Evaporation of vehicle before use: The solvent was allowed to evaporate off prior to incorporation into artificial soil.

Test organisms

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Common name: Eisenia fetida
- Source: Original Organics Limited, Langlands Business Park, Devon, UK
- Weight at test initiation: 0.30 g - 0.48 g
- The test organisms were with clitellum and were transferred into artificial soil approximately 24 hours prior to the start of the test.

Study design

Study type:

laboratory study

Substrate type:

artificial soil

Remarks:

Industrial quartz sand: 70% w/w Kaolinite clay: 20% w/w Sphagnum moss peat: 10% w/w

Limit test:

yes

Total exposure duration:

14 d

Test conditions

Test temperature:

21°C to 23°C.

pH:

6.0 ± 0.5

Moisture:

The moisture content of the soil used in the definitive test was 29% of dry weight of basic substrate on Day 0 and 27% to 28% on Day 14.

Details on test conditions:

Light intensity was 423 to 580 lux

Nominal and measured concentrations:

Based on the results of the range-finding test a "limit test" was conducted at a concentration of 1000 mg/kg of soil.

Reference substance (positive control):

yes

Remarks:

chloroacetamide

Results and discussion

Effect concentrations

Effect concentrations 1

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

Effect concentrations 2

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

Effect concentrations 3

Key result

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

>= 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

There were no mortalities or sub-lethal effects of exposure in 60 earthworms exposed to a test concentration of 1000 mg/kg for a period of 14 days. It was considered unnecessary and unrealistic to test at concentrations in excess of 1000 mg/kg.
The No Observed Effect Concentration (NOEC) was greater than or equal to 1000 mg/kg on the basis that no mortalities were observed after 14 days exposure and additionally no sub-lethal effects on weight or behaviour were observed at 1000 mg/kg.

Results with reference substance (positive control):

- Results with reference substance valid: The results were within the normal range for this reference item of 10 to 50 mg/kg.
- Relevant effect levels: 14-d LC50= 32 mg/kg with 95% confidence limits of 29 - 35 mg/kg. NOEC=18 mg/kg

Reported statistics and error estimates:

Statistical analysis using Bartlett's test for homogeneity of variance (Sokal and Rohlf 1981) and a Students t-test was carried out on the earthworm weight data.
The earthworm weights for the control at Day 0 were found to be significantly heavier (P<0.05) compared to the 1000 mg/kg test group, however as there were no significant differences in terms of weight between the solvent control and 1000 mg/kg test group, and the direct comparison was between the solvent control and 1000 mg/kg test concentration, it was considered that the differences observed on Day 0 did not affect the outcome or validity of the test. Review of the data suggests that this difference was likely due to a small number of particularly heavy individuals in the control group. There were no significant differences (P~0.05) between the solvent control, control and 1000 mg/kg test group in terms of weight on Day 14.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of the test item, to the earthworm Eisenia foetida, in an artificial soil test has been investigated and gave a 14-Day LC50 value of greater than 1000 mg/kg.
Correspondingly the No Observed Effect Concentration was greater than or equal to 1000 mg/kg.