Registration Dossier

Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
december 29, 1989
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source


Materials and methods

Test guideline
according to guideline
EPA OTS 797.1300 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
Version / remarks:
40 CFR Part 797.1300 and 50 FR 39321, 9/27/85 "Daphnid acute toxicity test"
GLP compliance:

Test material

Constituent 1
Chemical structure
Reference substance name:
Cocamidopropyl PG-dimonium chloride
Cas Number:
Molecular formula:
C20-30H43-63ClN2O2 range
Cocamidopropyl PG-dimonium chloride
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 in ambient laboratory 21C, sealed product container

Sampling and analysis

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

Test solutions

Details on test solutions:
Exposure volume 15 mL
Replication: 5 daphnids/replicate, 4 replicates/treatment
Concentrations: 0.10, 0.18, 0.32, 0.56, and 1.0 ppm nominal

Test organisms

Test organisms (species):
Daphnia pulex
Details on test organisms:
organism age < 24 hrs at test initiation
organism history: USTC 57th generation, 5th brood, 6/19/89
Feeding regime: none during test

Study design

Test type:
Water media type:
Round valley reservoir, Lebanon, NJ activated carbon stripped and 0.45micron filtered
Total exposure duration:
48 h

Test conditions

120 mg/L CaCO3
Test temperature:
20 +/- 2 C
pH (24hrs) = 8.3
pH (48hrs) = 7.8
Dissolved oxygen:
9.0 mg/L at both 24 hr and 48 hr test
alkalinity: 50 mg/L CaCO3
At 24hr test: 110 microm hos
At 48hr test: 120 microm hos
Nominal and measured concentrations:
nominal concentrations: 0.10 / 0.18 / 0.32 / 0.56 / 1.0 ppm
Details on test conditions:
Aeration: aerate by mixing test solutions to saturation prior to test; no aeration during test required.
test vessels: 18 x 150 mm glass tubes with Kaput caps
Illumination: 16:8 hour light/dark cycle fluorescent, 50 to 100 ft-candles (lab ambient)
Reference substance (positive control):
diluent, no solvent required

Results and discussion

Effect concentrations
Key result
48 h
Dose descriptor:
Effect conc.:
0.6 other: ppm
Nominal / measured:
Basis for effect:
Details on results:
The LC50 (48hrs) = 0.60 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 moratlity after 48hr 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

48 hr LC50= 0.60 ppm nominal concentration (95% confidence limits = 0.51 - 0.72)
Executive summary:

Using 40 CFR Part 797.1300 and 50 FR 39321, 9/27/85 "Daphnid acute toxicity test", the toxicity to aquatic invertebrates (Daphnia Pulex) has been described by nominal concentration in a 48 hr test. The result is:

48 hr LC50= 0.60 ppm nominal concentration (95% confidence limits = 0.51 - 0.72)