4,4'-methylenedianiline

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

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 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Analysis samples taken from each test vessel at the start of the exposure and at 24h after the start of the exposure and before the exchange with fresh test solution.

Vehicle:

no

Details on test solutions:

The total quantity of test solution was replaced each day with fresh solution.

Test organisms (species):

Oryzias latipes

Details on test organisms:

Supplier: Sankyo Fishery Co., Ltd
Size: 2.09cm (1.81 - 2.44 cm), n=10
Weight: 0.186g (0.087 - 0.452g), n = 10
Feeding: none during test

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

Total hardness - 68 mg/l (as CaCO3)

Test temperature:

24 +/- 1°C (23.1 - 24.5°C)

pH:

6.8 - 7.5

Dissolved oxygen:

5.7 - 8.5 mg/l

Nominal and measured concentrations:

Nominal concentrations 0, 14.0, 23.0, 37.0, 61.0 and 100 mg/l

Reference substance (positive control):

yes

Remarks:

copper sulphate pentahydrate

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

20.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Results with reference substance (positive control):

LC50 after 96h against copper sulphate was 1.4mg/l. The value was consistent with the LC50 value at the laboratories, since 1995 (n=22). [mean value 0.9 +/- 0.28mg/l; range 0.44 - 1.5mg/l]

Reported statistics and error estimates:

LC50 determined by Probit method.

Validity criteria fulfilled:

yes

Description of key information

Several studies on the acute toxicity of the test item to different fish species are available. The most sensitive and most reliable study (Mitsubishi, 2002) was with test species Oryzias latipes. An LC50 (96h) of 20.6 mg/L was determined. All studies revealed effect values within the same range between 20 and 53 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

20.6 mg/L

Additional information

Several studies on the acute toxicity of the test item to different fish species are available. The most sensitive and most reliable study (Mitsubishi, 2002) was conducted according to the OECD guideline 203 and GLP regulations with the test species Oryzias latipes. An LC50 (96h) of 20.6 mg/L (nominal concentration) was identified.

Other non GLP studies according to the OECD guideline 203 reveal LC50 values within the same range for other species. Due to acceptable restrictions in documentation (non GLP), these studies were rated less reliable than the Mitsubishi study. Nevertheless, these studies are adequate to support the previous described findings. Caspers et al., 1986 determined a LC50 (96h) of 65 mg/L with Danio rerio, similar results with an LC50 of 42 mg/L were obtained from Rufli & Mueller, 1985 with the same species. A slightly lower value was measured for Oncorhynchus mykiss, the LC50 was 39 mg/L. In other non-guideline studies similar effect values were documented (Oryzias latipes: LC50(48h) =) 32 ppm, CITI 1992; Leuciscus idus: LC50 (96h)= 53 mg/L) These studies were conducted according to national regulations and did not follow international guidelines. All studies revealed effect values within the same range between 20 and 53 mg/L.