4,4'-methylenedianiline

Toxicity to soil macroorganisms except arthropods

Link to relevant study record(s)

Reference

Endpoint:

toxicity to soil macroorganisms except arthropods: long-term

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Vehicle:

yes

Details on preparation and application of test substrate:

The stock solution was prepared in ethanol. An appropriate amount of the stock and the dosage solutions, respectively was used to soak a
portion of the quartz sand of the artificial soil. After evaporation of the solvent by placing under a fume hood, the quartz sand was incorporated into the remainders of the artificial soil to prepare the different test item soil concentrations.

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Common name: Earthworms
- Source: ECT Oekotoxikologie GmbH since February 1994; originally delivered by Co. Landenberger (72355 Schömberg, Germany)
- Age at test initiation (mean and range, SD): 2 - 12 months
- Weight at test initiation (mean and range, SD): 300 - 600 mg

ACCLIMATION
- Acclimation period: 2 days
- Acclimation conditions (same as test or not): same as test
- Health during acclimation (any mortality observed): healthy

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

no

Total exposure duration:

56 d

Test temperature:

18.3 – 21.6 °C

pH:

20 ± 2 ºC

Moisture:

50.7 - 59.9 % of WHCmax

Nominal and measured concentrations:

Concentrations tested: Solvent control, control; 18.0, 32.0, 56.0, 100, 180 and 320 mg test item/kg artificial soil (dw).

Measured 95.3 - 97.7 % of nominal in the test solution of the highest concentration.

Reference substance (positive control):

yes

Remarks:

Carbendazim

Duration:

56 d

Dose descriptor:

NOEC

Effect conc.:

< 18 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Duration:

56 d

Dose descriptor:

EC10

Effect conc.:

11.2 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Description of key information

An experimental study with Eisenia fetida predicted an EC10 of 11.2 mg/kg soil dw, after 56 d exposure to the test item

Key value for chemical safety assessment

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

11.2 mg/kg soil dw

Additional information

An experimental study with Eisenia fetida according to OECD guideline 222 and GLP regulations assessed the long-term toxicity of the test item to soil macroorganisms. An EC10 of 11.2 mg/kg soil dw was obtained after 56 d exposure time based on the reproduction of the test species (ECT, 2012). A supporting study with the same species but a short exposure period and a higher maximal test concentration revealed a NOEC of 180 mg/kg soil dw and an EC50 of 444 mg/kg soil dw (TNO, 1992). Since these results are based only on nominal concentrations and no analytical monitoring was conducted, they are only used as supporting data which give a hint for a possible lower toxicity of the test item to soil macroogranism than predicted by the ECT study. Assuming the worst-case further assessments are made based on the ECT results.