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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Administrative data

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

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
(±)-1-Benzyl-4-(4-fluoro-phenyl)-3-hydroxymethyl-1,2,3,6-tetrahydro-pyridine, salt with benzenesulfonic acid
EC Number:
Cas Number:
Molecular formula:
(±)-1-Benzyl-4-(4-fluoro-phenyl)-3-hydroxymethyl-1,2,3,6-tetrahydro-pyridine, salt with benzenesulfonic acid
Test material form:
solid: crystalline

Sampling and analysis

Analytical monitoring:

Test solutions

Details on test solutions:
The test organism was bred and held in Elendt M4 medium which was also used for preparing of test item solutions. Young daphnids aged less than 24 hours at the start of the experiment were exposed to the test item for a period of 48 hours and acute toxic effect displayed as immobilization of test organism recorded at 24 and 48 hours after the start of test. The stock solution was prepared by measuring 30.16 mg of test item into 1 000 ml Elendt M4 growth medium. The suspension was stirred till complete

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
Test species: Daphnia magna Straus
Age: < 24 hours neonates
Origin: National Institute of Environmental Health
Date of arriving: 16 May 2013

Study design

Test type:
Water media type:
Limit test:
Total exposure duration:
48 h

Test conditions

Nominal and measured concentrations:
The toxic property of test item was investigated at six concentrations which were prepared by different dilutions of stock solution of test item. Elendt M4 medium was used for dilution of stock solution. In the test the following nominal concentrations were applied: 0.95; 2.37; 4.73; 9.47; 18.93 and 28.40 mg/L.
Details on test conditions:
Selection of young daphnids
On the first day of the test, all of juvenile daphnids were removed from the selected breeding cultures by sieving. Juvenile daphnids were disposed. Next day the neonates (which are younger than 24 hours) were separated from the parental culture by filtering and were transferred into test vessels.

Results and discussion

Effect concentrationsopen allclose all
48 h
Dose descriptor:
Effect conc.:
2.36 mg/L
Nominal / measured:
Conc. based on:
test mat.
Basis for effect:
Key result
48 h
Dose descriptor:
Effect conc.:
4 mg/L
Nominal / measured:
Conc. based on:
test mat.
Basis for effect:
Details on results:
The effective concentrations (ECx) were calculated with Probit analysis using linear max. Likelihood regression. The EC10, EC20 and EC50 were calculated for immobility at both 24 h and 48 h period.The No Observed Effect Concentration (NOEC) and Lowest Observed Effect Concentration (LOEC) of the test item were determined with Fisher’s exact binominal test with Bonferroni correction by ToxRat® software.

Applicant's summary and conclusion

Validity criteria fulfilled:
Acute toxic effect of Rac. hydroxy-methyl-tetrahydropyridine tosilate was investigated in Daphnia sp. Acute Immobilisation test (according to OECD 202 guideline). The EC50 was 4.00 mg/L at 48 h.
In this Daphnia sp., Acute Immobilisation Test for Rac. hydroxy-methyl-tetrahydropyridine tosilate the results indicated that the test item is hazardous to the aquatic environment and classified into the second acute toxic hazardous category [GHS Acute aquatic hazard Category Acute II. – 48 hr EC50 (for Crustacea) > 1 mg/L but ≤ 10 mg/L]