4-Butyl-4''-ethyl-2'-fluor-1,1':4',1''-terphenyl

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:

May 2, 2013 - Dec. 31, 2013

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

no OECD GLP

Justification for type of information:

This study was performed according OECD TG 207. The quality system applied was not OECD GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

GLP compliance:

no

Remarks:

no OECD GLP

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: L012138874
- Expiration date of the lot/batch: 2014-10-31
- Purity: > 99.92 %

Analytical monitoring:

no

Vehicle:

yes

Remarks:

Acetone

Details on preparation and application of test substrate:

Artificial soil test substrate was prepared as follows:
a) 10 per cent sphagnum peat (pH 6.0, no visible plant remains, finely ground, dried).
b) 20 per cent kaolin clay (kaolinite content preferably above 30 per cent).
c) 70 per cent industrial sand (fine sand should be dominant with 60 per cent of the
particles between 50 and 200 microns).
d) pH is adjusted to 6.0 by addition of calcium carbonate.
The dry constituents were blended in the correct proportions and mixed thoroughly with a
large-scale laboratory mixer.


Test subsance amount was calculated based on dry weight

Test organisms (species):

Eisenia fetida

Details on test organisms:

TEST ORGANISM
- Common name: Eisenia fetida
- Source: Earthworm nursery of Nanjing city in China
- Breeding generation: E20130415
- Age at test initiation (mean and range, SD): 2 month
- Weight at test initiation (mean and range, SD): 397 mg

ACCLIMATION
- Acclimation period: 24 h
- Acclimation conditions (same as test or not): no feeding
- Health during acclimation (any mortality observed): no mortality, no other findings

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

yes

Total exposure duration:

14 d

Test temperature:

20-22 °C

pH:

5.78 - 5.84

Moisture:

35% dry soil weight

Details on test conditions:

TEST SYSTEM
- Test container (material, size): 1 L glass vessel, closed
- Amount of soil or substrate: 750 g
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 4
- No. of replicates per vehicle control: 4



OTHER TEST CONDITIONS
- Photoperiod: 24 h/day
- Light intensity: 400 - 800 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
day 0 and 14

VEHICLE CONTROL PERFORMED: yes

TEST CONCENTRATIONS
1000 mg/kg dw

Nominal and measured concentrations:

1000 mg/kg dw

Reference substance (positive control):

no

Key result

Duration:

14 d

Dose descriptor:

LD50

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

The mortalities of the blank control group, the solvent control group and the treatment group on day 14 were 0%.

Results with reference substance (positive control):

LD50 at about 25 mg/kg soil dw

Reported statistics and error estimates:

Standard statistical methods have been applied for data processing.

Validity criteria fulfilled:

yes

Conclusions:

Under conditions of the test, the 14 -day LD50 for the test substance to earthworms (Eisenia fetida) based on nominal test concentrations were higher than 1000 mg/kg dry soil weight.

Executive summary:

Study Design

In this study, the acute toxicity of the test substance to Eisenia fetida was determined in a 14 days artificial soil test. The study design followed the "OECD, Guidelines for the Testing of Chemicals, 1984, 207 Earthworm, Acute Toxicity Test".

Based on the results of range-finding test, one treatment group, one blank control group, and one solvent control group which had four replicates of 10 worms per concentration each were included in limit test. The nominal concentration of the treatment group was 1000 mg/kg dry artificial soil weight. The number of mortalities were determined after 14 days exposure.

Results

There was no mortality of the earthworms in the control group, therefore the test was valid.

After test material exposure, there was no mortality obvserved.

Conclusion

Under conditions of the test, the 14 -day LD50 for the test substance to earthworms (Eisenia fetida) based on nominal test concentrations were higher than 1000 mg/kg dry soil weight.

Description of key information

The informtion for this endpoint study record was obtained from an experimental study. The GLP (China) criteria were met and the methods applied are fully compliant with OECD TG 207. Under conditions of the test, the 14 -day LD50 for the test substance to earthworms (Eisenia fetida) based on nominal test concentrations were higher than 1000 mg/kg dry soil weight.

Key value for chemical safety assessment

Short-term EC50 or LC50 for soil macroorganisms:

1 000 mg/kg soil dw