Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
yes
Details on sampling:
Samples were collected of the Stock Solution (WAF) and of each treatment at the beginning and end of exposure for analysis.
Vehicle:
no
Details on test solutions:
Blacksburg, Virginia municipal tap water was dechlorinated using activated carbon,
deionized using mixed bed deionization tanks to a resistivity of > 1 megohm-cm, and
polished with a Millipore, Milli Q UV Plus and 0.2-micron filter to a final resistivity of ≥
18 megohm-cm. This water is referred to as BMI DI water.
This DI water was then chemically reconstituted according to U.S. EPA guidelines to a
final hardness of 160-180 (mg/l as CaCO3). This is BMI Hard Reconstituted Water
(HRW) and is the standard dilution water for testing with Daphnia magna.
Test organisms (species):
Daphnia magna
Details on test organisms:
Daphnia magna obtained from Aquatic Biosystems, Inc. (Fort Collins, Colorado) were
used for this study. Organisms were purchased and acclimated to BMI’s culture facility.
Once adults were produced, gravid females were segregated into fresh dilution water.
Organisms used in testing were < 24h old organisms from the 2nd to 5th generation. All
daphnid tests were initiated with offspring produced from BMI’s culture system and
obtained from a healthy culture stock showing no signs of stress such as >20% mortality,
presence of males or ephippiates, or discolored animals with no delay in production of
first brood.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
10.97 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
not determinable
Details on results:
Range Finding Test
Prior to conducting the definitive toxicity test, a range finding toxicity test was conducted
to determine the product concentrations to be used in the acute definitive testing. A
nominal concentration loading ratio was used for the range finding test consisting of
WAF concentrations 0.1, 1.0, 10, 100 and 1000 mg/L plus a control concentration. Five
Daphnids were exposed to each concentration and the control for the test duration of 48
hours. The number of mobile organisms for each concentration was recorded daily for
the test. The pH, conductivity, dissolved oxygen, and temperature of the control and five
concentrations were measured at the beginning and end of the study. Alkalinity and
hardness were measured for the control at the beginning of the test. The endpoint was
48-hour EC50 (the concentration that effects 50% of the organisms).
Definitive Test
The methods used for the definitive test conformed to OECD 202 guidelines. Based on
the range finding test results, a Definitive Test was conducted on seven concentrations
with a maximum nominal concentration of 100 mg/L (47 mg/L measured) plus a control.
A 0.5 dilution factor was used. Twenty Daphnids were exposed to each concentration
and the control for the test duration of 48 hours. The number of mobile organisms for
each concentration was recorded daily for the study. The pH, conductivity, dissolved
oxygen, and temperature of the control and test concentrations were measured daily
during the study. Alkalinity and hardness were measured for the control at the beginning
of the test. The endpoint was the 48-hour EC50 value.
The range finding test indicated that, in a definitive bioassay, there would likely be a result
(EC50) between 10 and 100 mg/L (nominal concentration).
The definitive test produced a 48-hour EC50 value of 10.97 mg/L based on the Spearman Karber
statistical method. The 95% lower and upper confidence levels were 9.37 and 12.85 mg/L,
respectively.
Validity criteria fulfilled:
yes
Conclusions:
Daphnia magna was exposed to cyclohexanemethanamine, 5-amino-1,3,3-trimethyl-, reaction products with glycidyl tolyl ether in acute tocicity test. The test produced a 48-hour EC50 value of 10.97 mg/L based on the Spearman Karber
statistical method. The 95% lower and upper confidence levels were 9.37 and 12.85 mg/L, respectively.
Executive summary:

Daphnia magna was exposed to cyclohexanemethanamine, 5-amino-1,3,3-trimethyl-, reaction products with glycidyl tolyl ether in acute tocicity test. The test produced a 48-hour EC50 value of 10.97 mg/L based on the Spearman Karber

statistical method. The 95% lower and upper confidence levels were 9.37 and 12.85 mg/L, respectively.

Description of key information

Daphnia magna was exposed to cyclohexanemethanamine, 5-amino-1,3,3-trimethyl-, reaction products with glycidyl tolyl ether in acute tocicity test. The test produced a 48-hour EC50 value of 10.97 mg/L based on the Spearman Karber

statistical method. The 95% lower and upper confidence levels were 9.37 and 12.85 mg/L, respectively.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
10.97 mg/L

Additional information