Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10/11/1999 - 20/12/1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: granule

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Sampling at 0-hour (test initiation) and 96-hour (test termination)

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
Species/strain: Rainbow trout (Oncorhynchus mykiss)
Wild catch: No
Age/size: Mean body length at test initiation: 5.5 ± 0.32 cm (Mean ± SD; range: 5.1 - 5.9 cm)
Mean body wet weight at test initiation: 1.9 ± 0.31 g (Mean ± SD; range: 1.4 - 2.4 g).
Kind of food: Commercial fish diet (HOKOVIT 502, 1.2 mm, supplied by H.U. Hoffmann AG, CH-4922 Bützberg, Switzerland)
Amount of food: Not reported
Feeding frequency: Not reported
Pretreatment: The test fish were treated for diseases immediately after arriving at the test facility, then held for more than two weeks without any further medication. The fish were then acclimated for one additional week prior to the test start to the test water and temperature (12 – 13ºC).
Feeding of animals during test: No

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
None

Test conditions

Hardness:
1.25 mmol/L (= 125 mg/L) as CaCO3
Test temperature:
12 – 13°C
pH:
7.7 – 8.0
Dissolved oxygen:
8.9 – 9.6 mg/L
Salinity:
Not applicable
Nominal and measured concentrations:
See table below
Details on test conditions:
Test water aerated slightly until oxygen saturation was reached.
Photoperiod: 16 hours light/8 hours dark daily
Reference substance (positive control):
no

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% C.I.
Details on results:
No concentration/response curves were reported.
No adverse effects.
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
None

Any other information on results incl. tables

Nominal and measured concentrations:

Nominal test

Concen-tration (mg/L)

Sample date

 

 

(day)

Sample

Age

 

 

(hours)

Measured Concent-ration

 

(mg/L)1

% of Nominal2

Mean Measured Concentrat-ion

(mg/L)

Mean Measured % of Nominal

100

0

0

0

0

98.94

99.88

99

100

99.4

99

4

4

96

96

99.26

99.80

99

100

99.5

100

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
No remarkable observations were made concerning the appearance of the test medium. The pH values in the test medium and the control ranged from 7.7 to 8.0. The oxygen concentration was always 8.9 mg/L or higher, and thus higher than 60% oxygen saturation. The water temperature ranged from 12 to 13 °C.

In the control and at the test concentration of 100 mg/L no mortality or other signs of intoxication were observed during the test period of 96 hours. Therefore, the 96-hour NOEC was 100 mg/L. The 96-hour LC0 was determined to be ≥ 100 mg/L and the 96-hour LOEC, the 96-hour LC50, and the 96-hour LC100 of dinotefuran to rainbow trout were all determined to be > 100 mg/L.

After 96 hours of exposure, there were no mortalities or signs of intoxication. Based on the results of this study, dinotefuran would be classified as practically nontoxic to juvenile rainbow trout (Oncorhynchus mykiss) on an acute toxicity basis.