Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
Qualifier:
according to guideline
Guideline:
other: 'The Guidelines for the Testing of Chemicals, Effects on Biotoc Systems' Beijing: China Environmental Press. 2013
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
'Chemicals-Fish acute toxicity test' (GB/T 27861-2011)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 6-ethyl-3-methyloct-5-en-1-ol and 6-ethyl-3-methyloct-6-en-1-ol
Molecular formula:
C11H22O
IUPAC Name:
Reaction mass of 6-ethyl-3-methyloct-5-en-1-ol and 6-ethyl-3-methyloct-6-en-1-ol
Test material form:
other: liquid
Details on test material:
Test substance: Super Muguet
Chemical Name: 6-Ethyl-3-methyl-6(5)-octen-1-ol
Chemical formula: C11H22O
Molecular weight: 170.3 g/mol
CAS: 26330-64-3; 26330-65-4
Appearance: colourless to pale yellow liquid

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
other: Rare minnow (Gobiocypris rarus)
Details on test organisms:
The Rare minnow, (Gobiocypris rarus) were obtained as fry from a fish supplier of Institute of Hydrobiology, Chinese Academy of Sciences.
Feeding fry were at least held for 12 days in holding tanks supplied with the continuous flow of aerated water before being used for the test. In the study, the test fish were held 23 days in the range-finding and 33 days in the defintive test, respectively. Fish to be used in the test were held for 7 days in water of the quality and temperature to be used in the test.
A photoperiod of 16 hours light, provided by overhead fluorescent tubes, and 8 hours dark was maintained. The oxygen concentration was more than 80% of the air saturation value.
The fish were fed daily during the holding period on proprietary fish food. They were held without food for approximately 24 hours before being placed into the test vessels.
Characteristics of the fish food are measured at least twice a year by Jiangsu Provincial Center for Disease Prevention and Control.
During the holding period the tanks were inspected daily and any debris or unhealthy or dead fish removed.

Fish selection criteria
After the 48 hour settling-in period, no mortality was observed in the following 7 days. So the batch of fish (Batch No.: F20140115) was accepted.
10 fish were randoly selected and weight and length were measured: the wet-weight of the fish used for the definitive test was 0.272g in average, with an average length of 2.52cm. These fish were not used for toxicity testing.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
none

Test conditions

Hardness:
The total hardness was in the range of 120 to 123 mg (CaCO3)/L
Test temperature:
Temperature: 22.5 to 23.1 °C
pH:
pH values of the control mediums and test mediums were between 7.87 and 8.39
Dissolved oxygen:
Oxygen concentraiton: 77% to 82% of the air saturation; No aeration
Nominal and measured concentrations:
Range finding test: Nominal concentration of 1.00, 10.0 and 100 mg/L.

Definitive test:
Nominal contentrations of 1.00, 2.00, 4.00, 8.00 and 10.00 mg/L
Measured concentrations of 0.929, 1.84, 3.86, 7.41, 8.81 mg/L
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
4.1 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CL: 3.30 - 5.09 mg/L
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
2 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
8 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
The biological effect results are based on the average of the measured concentrations at 0, 24, 48, 72 and 96 hours.
Results with reference substance (positive control):
The test with the reference substance is performed at least once with each batch of fish as a means of assuring that the laboratory test conditions are adequate and have not changed significantly. The resulting 24h-LC50 was 283 mg/L.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The results showed that under valid static test conditions, the 96 h-LC50 of the test substance Super Muguet to Rare minnow (Gobiocypris) is 4.10 mg/L with 95% confidence limit of 3.30 - 5.09 mg/L (based on the measured concentration). The maximum test concentration causing no mortality (96 h-LC0) is 2.00 mg/L (measured concentration, 1.84 mg/L). The minimum concentration causing 100% mortality (96 h-LC100) is 8.00 mg/L (measured concentration, 7.41 mg/L).