4,4'-methylenedianiline

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

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)

Analytical monitoring:

yes

Details on sampling:

Three times, before and after, exchange of test solutions during the 21 days exposure.

Vehicle:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

- Developing stage: female infant (younger than 24h)
- Supplier: National Institute for Environmental Studies
- Feed (during test): Chlorella vulgaris (algae cultivation solution was centrifuged and the water layer was exchanged with the dilution water)
-Feed quantity: 0.15mgC (organic carbon content/animal/day)

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Remarks on exposure duration:

Test solution exchanged daily

Hardness:

ca. 250mg/l (corresponding to CaCO3)

Test temperature:

20+/-1°C

pH:

7.3 - 8.3

Dissolved oxygen:

7.2 - 8.8 mg/l

Nominal and measured concentrations:

Nominal concentrations: 0, 0.0060, 0.0190, 0.0600, 0.190 and 0.600 mg/l

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

0.005 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

0.018 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

0.015 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

reproduction

Results with reference substance (positive control):

Sensitivity: EC50 after 48h against potassium dichromate was 0.89mg/l. The value was consistent with the EC50 values of the Laboratories (since June 1998, n=8) as follows: mean value +/- sd = 0.75 +/- 0.18 mg/l range 0.57 - 1.02 mg/l

Validity criteria fulfilled:

yes

Description of key information

The 21d NOEC value of 0.00525 mg/L indicates that MDA is toxic to invertebrates (Mitsubishi, 2002)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

NOEC

Effect concentration:

0.005

Additional information

An experimental study according to OECD guideline 211 and GLP regulations was carried out with Daphnia magna for 21 d to assess the chronic toxicity to aquatic invertebrates. The 21d NOEC value of 0.00525 mg/l indicates that MDA is toxic to invertebrates (Mitsubishi, 2002). Hence, these is the most sensitive species of all tested trophic levels and this NOEC value may be used to derive a PNEC_aqua value.

A study according to OECD 202 and GLP regulations with the species Moina macrocopa revealed a 14 d NOEC of 0.15 mg/l (Fujiwara 1982). Due to less reliability and less sensitivity of the species, this is only used as supporting study.