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Ecotoxicological information

Long-term toxicity to fish

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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 4th 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.