Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented report of a guideline study conducted to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Committee on Methods for Toxicity Tests with Aquatic Organisms. 1975. Methods for Acute Toxicity Tests with Fish, Macroinvertebrates and Amphibians. Environmental Protection Agency, Ecological Research Series EPA-660/3-75-009, April 1975.
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Aqueous solution of diallyldimethylammonium chloride - EH&S 248 in water at 38.25%
- Name of test material (as cited in study report): EH&S 248
- Molecular formula (if other than submission substance): C8H16N.Cl
- Molecular weight (if other than submission substance): 161.68
- Smiles notation (if other than submission substance): C(=C)CN{+}(c)(c)(.Cl{-})CC=C
- InChl (if other than submission substance): 1/C8H16N.ClH/c1-5-7-9(3,4)8-6-2;/h5-6H,1-2,7-8H2,3-4H3;1H/q+1;/p-1
- Substance type: non-volatile, organic in aqueous solution
- Physical state: clear liquid
- Analytical purity: 38.25%
- Impurities: water, 61.75% dimethylamine (233 ppm)
- Composition of test material, percentage of components: 38.25%
- Purity test date: 03-1983
- Lot/batch No.: Batch #7375, Lot #G3407
- Expiration date of the lot/batch: no data
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
yes
Details on test solutions:
Reconstitued, deionized water with 48 mg NaHCO3, 30 mg CaSO4.2H2O, 30 mg MgSO4, 2 mg KCl per litre.

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout (Salmo gairdneri)
- Strain: no data
- Source: Spring Creek Trout Hatchery in Lewistown, Montana (ABC lot # 283)
- Age at study initiation: no data
- Length at study initiation: 36 (±3.5) mm
- Weight at study initiation: 0.67 (±0.21) g
- Method of breeding: no data
- Feeding during test: no
ACCLIMATION
- Acclimation period: 48 hors
- Acclimation conditions: same as test
- Type and amount of food: none

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
No

Test conditions

Hardness:
40-45 mg/l CaCO3
Test temperature:
12°C
pH:
7.2- 7.7
Dissolved oxygen:
8.5 mg/l at pH 7.5 the dissolved oxygen concentration ranged from 8.8 to 7.3 mg/l representing 81 and 68% saturation at 12°C
Nominal and measured concentrations:
Nominal concentrations 100, 180, 320, 560 and 1000 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: open
- Material: 5-gallon glass vessels (containing 15 litres=
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: well water at ABC Laboratories
- Metals (ppm): Al < 0.007, As <0.001, Cd<0.001, Cr <0.002, Co<0.002, Cu <0., Fe<0.004, Pb <0.02, Hg <0.0001, Ni <0.004, Ag <0.002, Z <0.001
- Pesticides (ppb): Organophosphorus and chlorinated hydrocarbons residues: Malathion<0.1, Et Parathion <0.1, Disyston <0.1, Me Parathion <0.1, Diazinon <0.1
- Alkalinity: 368 ppm (as CaCo3)
- Intervals of water quality measurement: 0, 48 and 96h
TEST CONCENTRATIONS
- Spacing factor for test concentrations: logarithmic
- Range finding study
- Test concentrations: 1, 10, 100, and logarithmic series from 100 to 1000 mg/l
Reference substance (positive control):
yes
Remarks:
Antimycin A

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
180 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
420 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CI = 320-560 mg/l
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
560 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities:
- Observations on body length and weight: no data
- Other biological observations: none reported
- Mortality of control: 0
- Other adverse effects control: none reported
- Abnormal responses: Dark discolouration of the fish was observed in the test concentrations of 180 and 320 mg/l representing a 10% effect on remaining fish after 96 hours. The abnormal effects progressed from 560 mg/l initially to 180 mg/1 after 96 hours.
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none reported
- Effect concentrations exceeding solubility of substance in test medium: none reported
Results with reference substance (positive control):
LC50/Antimycin A/96 hours = 3.7x10-5 mg/l (2.4x10-5 - 7.5x10-5 mg/l)

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The LC50 of DADMAC solution at 38.25% concentration at 96 hours in Rainbow Trout (Salmo gardneri ) was 420 mg/l. Based on active substance this is equivalent to 160.65 mg/l. the NOEC was observed at 180 mg/l test article (68.25 mg DADMAC/l)