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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
[3R-(3α,3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl acetate
EC Number:
201-036-1
EC Name:
[3R-(3α,3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl acetate
Cas Number:
77-54-3
Molecular formula:
C17H28O2
IUPAC Name:
[3R-(3α,3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl acetate

Test solutions

Vehicle:
yes
Details on test solutions:
The stock solution used in the range-finding test was prepared by dissolving 1000 mg of the test item in volume completed to 1000 mL with dilution water, resulting in a concentration of 1000 mg.L-1. To assist solubilization, ultrasonic dispersion was also applied for 20 minutes.

The stock solution used in the definitive test was prepared by dissolving 1000 mg of the test item in volume completed to 1000 mL with dilution water, resulting in a concentration of 1000 mg.L-1. To assist solubilization, ultrasonic dispersion was also applied for 20 minutes.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
The fish were obtained from supplier Aquario Way (Taquaral - Campinas/SP), maintained and acclimated under laboratory-controlled conditions. The fish were healthy and free from any visible disease and abnormalities during the maintenance and acclimation periods

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Remarks on exposure duration:
Fish in the treatment groups and control group were observed for general symptoms at 24, 48, 72 and 96 hrs after exposure and the mortality was recorded.

Test conditions

Test temperature:
21 ~ 25 °C
pH:
7.6 ~ 7.8
Dissolved oxygen:
7.9 ~ 8.1 mg/L
Nominal and measured concentrations:
6.25; 12.5; 25; 50 and 100 mg/L.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
ca. 15.61 mg/L
Details on results:
The 24, 48, 72, and 96 hours cumulative mortality responses of Danio rerio to each test item concentration are shown in tables 5 and 6 for the range-finding and definitive tests, respectively. No mortality or sublethal effects were observed in the control group for the range-finding and definitive tests, showing that validity of the test was achieved. The 24 hours mortality of Danio rerio in each test concentration in the reference test with potassium dichromate is presented in the Table 7.

The values of 24, 48, 72 and 96-hour LC50 of Cedryl Acetate were 28.72; 15.39; 15.61 and 15.61 mg.L-1, respectively. The 24-hour LC50 value for the reference item, potassium dichromate, was 253.30 mg.L-1, demonstrating that the sensitivity of the fish was within the accepted range (ISO, 1982). All values of LC50 of both the test and reference items and their respective confidence limits are shown in Table 8.

The highest concentration that caused no lethal effect on fish was not determined and the lowest concentration that killed 100% of fish was 25 mg.L-1, in 96 hours of exposure period (Figure 4).

No sublethal effects on fish were observed at any of the tested concentrations.

Applicant's summary and conclusion

Conclusions:
The 96-hour LC50 value of Cedryl Acetate was 15.61 mg.L-1. The highest concentration that did not cause lethal effect on fish was not determined1, and the lowest concentration that caused 100% mortality on the fish population was 25 mg.L-1, in 96 hours of exposure period.