N,N-dimethylformamide

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

adult fish: sub(lethal) effects

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

TG was deleted on 2nd April 2014

Qualifier:

according to guideline

Guideline:

OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study)

Version / remarks:

Adopted 4th April 1984; TG was deleted on 2nd April 2014

Deviations:

not specified

GLP compliance:

yes

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test substance was kept in the refrigerator in the laboratory
- Stability under storage conditions: Based on infrared absorption spectrum measurements the substance, measured before starting the test and at the end, was considered stable.

Analytical monitoring:

yes

Vehicle:

no

Test organisms (species):

Oryzias latipes

Details on test organisms:

TEST ORGANISM
- Common name: Japanese Killifish
- Strain: Oryzias latipes
- Feeding during test : No food was fed 24 hours before the start of exposure
- Food type: The feed was commercially available tetramine

ACCLIMATION
- Acclimation period: 54 d
- Acclimation conditions (same as test or not): yes

Test type:

flow-through

Water media type:

other: water

Limit test:

no

Total exposure duration:

21 d

Hardness:

50 mg CaCO3/L

Test temperature:

24 ± 1 °C

pH:

7.4 - 7.9

Nominal and measured concentrations:

(nominal values) control, 29, 53, 102 mg/L (geometric ratio: 1.8).
Percentages of measurement concentrations for nominal concentration were within ± 20 % in all concentration areas. Accordingly, the result was calculated based on nominal concentrations.

Details on test conditions:

TEST SYSTEM
- Test vessel: 5.0 L glass beaker
- Material, size, headspace, fill volume: capacity 5.0 L
- Type of flow-through (e.g. peristaltic or proportional diluter): using continuous diluter with metering pump
- Renewal rate of test solution (frequency/flow rate): 35 L/day, 24.45 mL/min
- No. of organisms per vessel: 20 per concentration
- No. of vessels per concentration (replicates): 1

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light - 8 hours dark

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

> 102 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Duration:

21 d

Dose descriptor:

LC50

Effect conc.:

> 102 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Validity criteria fulfilled:

not specified

Conclusions:

The long-term toxicity of N,N-dimethylformamide in Japanese killifish has been reported, and the 21-day NOEC for growth was more than 102 mg/L.

Executive summary:

This GLP-study was conducted according to OECD Guideline 204 - Fish, Prolonged Toxicity Test: 14-day Study (Vadopted 4^th April 1984).

In this study the long-term toxicity of N,N-dimethylformamide in Japanese killifish (Oryzias latipes) has been investigated. Based on the results the determined 21-day NOEC for growth was more than 102 mg/L.

Description of key information

NOEC (21 d) > 102 mg/L for Japanese killifish (Oryzias latipes) (OECD Guideline 204, flow-through, GLP).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

102 mg/L

Additional information

In a GLP-study, conducted according to OECD Guideline 204 - Fish, Prolonged Toxicity Test: 14-day Study (Version 1984), the long-term toxicity of N,N-dimethylformamide in Japanese killifish (Oryzias latipes) has been investigated. Based on the results the determined 21-day NOEC for growth was more than 102 mg/L.

In a two-generation study with Pimephales promelas a MATC of 5 - 11 mg/L was found for the development of the F1 generation (data sponsored by the Environ. Res. Laboratory-Duluth, USA). In the same study Salvelinus fontinalis was exposed to the test substance. No effect on the F0 -generation was determined. However, a reduced survival rate in the F1 -generation was observed. Hence the MATC was determined to be between 42.8 and 98.2 mg/L. However, these values cannot be used for the hazard assessment, as the study is only available as draft with hand-written corrections. The report provided limited information which was not sufficient to evaluate the associated study. According to information from US-EPA the study was never finalised. Therefore, a validation was not possible.

Additionally, QSAR calculations are conducted using an extensive set of structure – activity relationships (SARs) by the computer program ECOSAR from US-EPA. Thereby, chronic values (ChV) of 1839.00 mg/L for fish and 571.97 mg/L for daphnid are calculated. However, the substance failed to fall in the applicability domain of the model.