Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 15, 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OTS 797.1400 (Fish Acute Toxicity Test)
Version / remarks:
40 CFR Part 797.1400 and 50 FR 39321, 9/27/85, "Fish acute toxicity test"
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: aqueous solution
Details on test material:
Lot# HH105P
Cocamidopropyl PG dimonium chloride
Lexquat AMG-WC
Specific details on test material used for the study:
sample storage: ambient laboratory, 21C, sealed product container

Sampling and analysis

Analytical monitoring:
yes
Remarks:
US EPA (NPDES) Probit Analysis Version 1.2

Test solutions

Details on test solutions:
Exposure volume 15L
Replication 11 fish/replicate, 2 replicates/treatment
nominal concentrations in ppm: 1.0 / 1.8 / 3.2 / 5.6 / 10

Test organisms

Test organisms (species):
other: salmo gardneri (rainbow trout)
Details on test organisms:
source: Trout Lodge, McMillan, Washington
History: Eggs hatched at USTC 3/27 to 3/30/89 (>97 hatch success)
age: 81 to 85 days at test initiation
Fish weight: mean = 1.43 g, N=10
Fish size: mean = 4.8 cm, longest = 5.9 cm shortest = 3.9 cm
Feeding regime: none during test

Study design

Test type:
static
Water media type:
freshwater
Total exposure duration:
96 h

Test conditions

Hardness:
170 to 190 mg/L CaCO3
Test temperature:
17C
pH:
at 24 hrs pH = 7.6
at 48 hrs pH = 7.5
at 72 hrs pH = 7.6
at 96 hrs pH = 7.6
Dissolved oxygen:
From 6.2 to 7.8 mg/L
Salinity:
80 mg/L CaCO3
Conductivity:
fro 220 to 240 micromhos
Nominal and measured concentrations:
nominal concentrations in ppm: 1.0 / 1.8 / 3.2 / 5.6 / 10
Details on test conditions:
Illumination
Test vessels 22 L non-plasticized polyethylene containers
Aeration:
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
3.5 other: ppm
Nominal / measured:
nominal
Basis for effect:
mortality
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
3.8 other: ppm
Nominal / measured:
nominal
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
4.5 other: ppm
Nominal / measured:
nominal
Basis for effect:
mortality
Details on results:
The LC50 (96hrs) = 3.5 ppm obtained represents toxicity caused solely by the product. Control mortality was absent and a consistent trend of increasing mortality with increasing product concentration was observed.
Adsorption of the product to exposure chambers may have occured during the test. However daily renewal of test concentrations mitigated these effects, if ony partially.
Chemical confirmation of nominal concentrations was not achieved however the LC50 estimate, are considered reasonably accurate and representative of the type of moiety.
Results with reference substance (positive control):
No mortality after 96 hr test.
Reported statistics and error estimates:
HPLC determination of nominal, low, high, and control concentrations was attempted. Frozen, coded samples were sent to the Sponsor July 12, 1989, but were not analysed until October 1989. In addition, the results were questionable since:
1) controls had detectable levels of test substance that should not in theory be present
2) analysed amount of products in test concentrations samples were from one to three orders of magnitude different (lower) from the nominal concentrations intended wuthou any obvious trend, or the levels were undetectable,
3) the methods could not distinguish among the three componds tested and may not be accurate at the low levels tested. Hence the chemical confirmation method may be flawed or the sample storage may have affected the results of chemical analysis or both.

Applicant's summary and conclusion

Conclusions:
96 hr LC50= 3.5 ppm nominal concentration (95% confidence limits not obtainable)
Executive summary:

40 CFR Part 797.1400 and 50 FR 39321, 9/27/85, "Fish acute toxicity test", the toxicity to fish (Rainbow trout) has been described by nominal concentration in a 96 hr test. The result is:

96 hr LC50= 3.5 ppm nominal concentration (95% confidence limits not obtainable)