Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (e.g. no analytical verification of the test concentrations)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: German Industrial Standard DIN 38412, part 15
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- test substance: N-Methylacetamide
- purity: 99 %

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
- test water: reconstituted freshwater was prepared from fully demineralized tap water, which was resalted by the addition of 294 mg/l CaCl2*2H2O, 123.3 mg/l MgSO4*7H2O, 64.8 mg/l NaHCO3, 5.8 mg/l KCl
- test water had a total hardness of 2.5 mmol/l, an acid capacity (to pH 4.3) of 0.8 mmol/l, 82 mg/l Ca, 12 mg/l Mg, > 8 mg/l oxygen, and ca. pH 8

Test organisms

Test organisms (species):
Leuciscus idus
Details on test organisms:
- animal species: Leuciscus idus L., golden variety (golden orfe)
- mean body length: 5.3 cm (4.7-5.8 cm)
- mean body weight: 3.7 g (2.1-4.9 g)
- mean corpulence factor of the batch: 2.5
- duration of adaptation to test water and test temperature: 3 days

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h

Test conditions

Details on test conditions:
- volume of test water: 10 l
- test vessels: all-glass aquaria (30x22x24 cm)
- aeration: continuously with oil-free air
- No. of animals per test concentration: 10
- loading (fish/vessel): 3.7 g/l
- temperature: 20 °C +- 1 °C
- nominal test concentrations: 0.0 (control), 1000, 2150, 4640, and 10000 mg/l
- observations: mortality after 1, 4, 24, 48, 72, and 96 h; symptoms after 4, 24 and 48 h
- measurements: pH and oxygen content after 1, 24, 48, 72, and 96 h
- the median lethal concentration (LC50) was calculated using Probit Analysis (Finney DJ, Probit Analysis, Cambr. Univ. Press, 3rd Edition, 1971)

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
3 390 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality

Any other information on results incl. tables

RS-Freetext:
Mortality:
----------
Nominal Cumulative mortality (n)
concentration (mg/l) 1 h 4 h 24 h 48 h 72 h 96 h
0 (Control) 0 0 0 0 0 0
1000 0 0 0 0 0 0
2150 0 0 1 3 3 4
4640 0 0 2 3 4 5
10000 0 0 7 9 10 10

Symptoms:
---------
Nominal Symptoms
concentration (mg/l) 1 h 4 h 24 h 48 h 72 h 96 h
0 (Control)
1000
2150 T
4640 T
10000 T N

Legend: T = tumbling; N = narcotic-like state


Oxygen:
-------
Nominal Oxygen content (mg/l)
concentration (mg/l) 0 h 24 h 48 h 72 h 96 h
0 (Control) 8.1 8.5 8.9 8.7 8.4
1000 8.2 8.6 8.7 8.7 8.6
2150 8.3 8.2 8.7 8.9 8.8
4640 8.0 8.0 8.9 8.9 8.7
10000 8.0 7.7 8.9 8.7 ---


pH:
---
Nominal pH
concentration (mg/l) 0 h 24 h 48 h 72 h 96 h
0 (Control) 8.0 7.8 8.0 8.7 8.4
1000 7.9 7.9 7.9 8.7 8.6
2150 7.8 7.8 7.9 8.9 8.8
4640 7.7 7.8 7.9 8.9 8.7
10000 7.7 7.7 8.0 8.7 ---


LC50
----
after 1 hour: > 10000 mg/l (1 % significance level)
after 4 hours: > 10000 mg/l (1 % significance level)
after 24 hours: 7240 mg/l (slope factor = 2.16)
after 48 hours: 4690 mg/l (slope factor = 2.21)
after 72 hours: 4600 mg/l
after 96 hours: 3390 mg/l (slope factor = 1.94)

NOEC: 1000 mg/l
LC0: 1000 mg/l
LC100: 10000 mg/l

The control with chloracetamide (48-h LC 50: ca. 26 mg/l)
corresponds to the normal sensitivity.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes