Reaction mass of 1-methyl-4-(1-methylethyl)-7-oxabicyclo[2.2.1]heptane and cineole

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Justification for type of information:

1,8-cineole (source substance) is one of the main constituents of the registered substance (target substance).

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

121 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95 % CL = 100-157

Details on results:

- Aafter the 24, 48, 72 and 96 hours of exposure, mortality was 0% at 100 mg.L-1, 71.4% at 125 mg.L-1 and 100% at 157, 198 and 250 mg.L
- LC50 values at 24, 48 and 72-96 h was calculated to be 121 mg.L

Results with reference substance (positive control):

- Results with reference substance valid: Yes
- LC50 (24 h): 179.15 mg/L (historical data, May 2013)

Reported statistics and error estimates:

The software ToxRat® Professional was used for the determination of the effective concentrations. The LC50 value was determined by Probit analysis using linear max. likelihood regression.

Sublethal observations / clinical signs:

ANALYTICAL RESULTS

Overall, the analytical results of the final semi-static test showed that preparation of test solutions was reproducible. Indeed, concentrations measured in freshly prepared solutions (t=0h and t= 48h) and in 24-hour old solutions revealed that the concentration of the test item was satisfactorily maintained within ± 20% of the initial and nominal concentration throughout the test. Since the deviation of the exposure concentrations of the test substance was not greater than ± 20% of the initial concentrations, it was decided to evaluate the biological effects on the nominal values for this study.

Nominal concentration (mg test item.L-1)	Start (t=0h)	t=24h Old	t=48h Old	t=48h Fresh	t=72h Old	End (t=96h)
Control	Absence	Absence	Absence	Absence	Absence	Absence
100	100.66	98.44	93.32	98.59	96.76	99.87
125	125.44	121.53	122.93	123.41	125.05	122.28
157	161.82	157.12
198	202.13	198.04
250	257.55	251.37

Validity criteria fulfilled:

yes

Remarks:

No mortality was observed in the control at the end of the test. The dissolved oxygen concentration was at least 60% of the air saturation value throughout the test . Results were based on nominal exposure concentrations.

Conclusions:

The toxic effect of the test item 1,8-CINEOLE to the zebrafish (Danio rerio) was investigated in a semi-static test. The evaluation was based on the nominal exposure concentrations. Under the experimental conditions, the 96-hour LC50 value estimated was 121 mg.L

Executive summary:

In an acute aquatic toxicity study performed according to OECD guideline 203 and in compliance with GLP, groups (7/concentrations) of zebrafish (Danio rerio) were exposed to 1,8 -CINEOLE at concentrations of 100, 125, 157, 198 and 250 mg/L [nominal concentration] for 96 h under semi-static conditions.

The mortality of the fish was determined in a semi-static 96-hour test by visual observation after 24, 48, 72 and 96 hours. Actual exposure concentrations were determined by chemical analyses at the start of the test and every 24 hours thereafter in old and new solutions.

The test item levels were found to be relatively stable throughout the test and the evaluation of the effects on fish was based on the nominal concentrations. After 96 hours of exposure, mortality was 0% at 100 mg.L-1, 71.4% at 125 mg.L-1 and 100% at 157, 198 and 250 mg test item.L-1. It should be noted that fish exposed to the concentrations of 157 to 250 mg.L-1 died rapidly. Hence, the highest concentration resulting in no mortality at 96 hours was 100 mg.L-1 and the lowest concentration resulting in 100% mortality at 96 hours was 157 mg.L-1.

The toxic effect of the test item 1,8-CINEOLE to the zebrafish (Danio rerio) was investigated in a semi-static test. The evaluation was based on the nominal exposure concentrations. Under the experimental conditions, the 96-hour LC50 value estimated was 121 mg.L.

Description of key information

Based on data available on 1,4 -cineole, the acute toxicity of test item REACTION MASS OF 1,4 -CINEOLE AND 1,8 -CINEOLE to fish is:

96-hour LC50 = 121 mg test item/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

121 mg/L

Additional information

In an acute aquatic toxicity study performed according to OECD guideline 203 and in compliance with GLP, groups (7/concentrations) of zebrafish (Danio rerio) were exposed to 1,8 -CINEOLE at concentrations of 100, 125, 157, 198 and 250 mg/L [nominal concentration] for 96 h under semi-static conditions.

The mortality of the fish was determined in a semi-static 96-hour test by visual observation after 24, 48, 72 and 96 hours. Actual exposure concentrations were determined by chemical analyses at the start of the test and every 24 hours thereafter in old and new solutions.

The test item levels were found to be relatively stable throughout the test and the evaluation of the effects on fish was based on the nominal concentrations. After 96 hours of exposure, mortality was 0% at 100 mg.L-1, 71.4% at 125 mg.L-1 and 100% at 157, 198 and 250 mg test item.L-1. It should be noted that fish exposed to the concentrations of 157 to 250 mg.L-1 died rapidly. Hence, the highest concentration resulting in no mortality at 96 hours was 100 mg.L-1 and the lowest concentration resulting in 100% mortality at 96 hours was 157 mg.L-1.

The toxic effect of the test item 1,8-CINEOLE to the zebrafish (Danio rerio) was investigated in a semi-static test. The evaluation was based on the nominal exposure concentrations. Under the experimental conditions, the 96-hour LC50 value estimated was 121 mg.L.