4-tert-butylcyclohexyl acetate

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

From 05.03.1985 to 07.03.1985

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Remarks:

This study was performed according to DIN 38412 part 15 without GLP statement. Solvent was used. The test duration was only 48 hours. Analytical measurements were not performed. Some information are missing to validate this study, such as information on the test substance and mortality in control.

Qualifier:

according to guideline

Guideline:

other: DIN 38412 Part 15

Deviations:

not specified

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

no analytical monitoring

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

yes

Test organisms (species):

Leuciscus idus melanotus

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Remarks on exposure duration:

none

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

15 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% CL: 13-16 mg/L

Sublethal observations / clinical signs:

Table 6.1.1/1: Raw data

Nominal concentration (mg/L)	48 hours
	Surviving	Dead	% mortality
10 13 16 20	10 9 2 0	0 1 8 10	0 10 80 100

Validity criteria fulfilled:

not specified

Conclusions:

The 48h-LC50 was determined to be 15 mg/L (95% Confidence limit at 13-16 mg/L).

Executive summary:

This study was performed according to DIN 38412 Part 15 without GLP statement, to assess the acute toxicity of the test substance to fish Leuciscus idus melanotus, under static conditions.

Fish were exposed to 4 nominal test substance concentrations (10, 13, 16 and 20 mg/L) with solvent during 48 hours and the mortality was recorded.

The 48h-LC50 was determined to be 15 mg/L (95% Confidence limit at 13 -16 mg/L).

Some information are missing to validate this study, such as mortality in control. Validity criteria cannot be verified.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 27.01.1997 to 21.02.1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

This study was performed according to EU Method C.1 with GLP statement. All validity criteria were fulfilled and no deviations from the protocol were observed. This study is well documented.

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

A series of concentrations in deionised water (2 stock solution representing the 2 test: at 33.7 mg/L and 29.8 mg/L, test concentrations at 2.8, 5.7, 8.5, 14.2, 24.1 and 28.4 mg/L) was prepared. The analytical monitoring was carried out at 0, 24, 48 and 72 hours.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method for stock solution: 1 g/L in drinking water, stirred for ca. 18 hours and then filtered.
- Eluate: Drinking water
- Controls: one control medium
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): not applicable
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no data

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Cyprinus carpio
- Source: Bio International B.V; Someren NL
- Length at study initiation (length definition, mean, range and SD): 3-4 cm
- Feeding during test: no

ACCLIMATION
- Acclimation period: no data
- Acclimation conditions (same as test or not): same as test (in dechlorinated drinking water in 200-300L glass aquaria at 20 +/- 2°C).
- Type and amount of food: TRUOVIT, amount c.a 1% bodyweight
- Feeding frequency: daily
- Health during acclimation (any mortality observed): No disease, <5% mortality.

QUARANTINE (wild caught)
- Duration: 14 days

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Remarks on exposure duration:

none

Post exposure observation period:

None

Hardness:

ca. 13 °dH.

Test temperature:

19.6-20.7°C.

pH:

8.0-8.4

Dissolved oxygen:

90-100% saturation

Salinity:

Not applicable

Nominal and measured concentrations:

- Nominal concentrations: 6.0, 7.5, 9.5 and 12 mg/L.

Details on test conditions:

TEST SYSTEM
- Test vessel: ca. 20 L
- Aeration: continuously
- Renewal rate of test solution (frequency/flow rate): daily change
- No. of organisms per vessel: 10 fish
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): not applicable

TEST MEDIUM / WATER PARAMETERS
Drinking water

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16/8h
- Light intensity: no data

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality

TEST CONCENTRATIONS
- Spacing factor for test concentrations: ca. 1.2
- Range finding study: yes
- Test concentrations of the range finding study: 4.0, 6.7, 12, 20 and 34 mg/L.
- Results used to determine the conditions for the definitive study: See table 6.1.1/1 in "Any other information on materials and methods incl. tables".

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

8.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% CL: 7.7-9.6 mg/L

Details on results:

- Analytical monitoring: See table 6.1.1/2 in "Any other information on results incl. tables". The measured values after 72 hours were not greater by more than 20% of the fresh concentrations. Based on this information, the results were based on nominal concentration only.
- Raw data: See table 6.1.1/3 in "Any other information on results incl. tables".
- Mortality of control: 10% of mortality at the end of the test (96h).

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

None

Sublethal observations / clinical signs:

Table 6.1.1/2: Analytical monitoring

Stability control (mg/L)	Actual concentration at 0h (mg/L)	Measured concentration at 24h (mg/L)	Measured concentration at 48h (mg/L)	Measured concentration at 72h (mg/L)
2.8 5.7 8.5 14.2 24.1 28.4	2.4 5.3 8.1 14.4 23.5 28.4	3.0 4.9 7.4 12.5 21.9 25.1	3.0 5.4 8.3 14.1 22.0 28.6	3.1 5.3 7.7 13.8 21.9 31.9
Stock solution - Range finding test	33.7	31.7	28.3	25.6
Stock solution - test	29.8	24.6	29.0	29.8

Table 6.1.1./3: Raw data

Nominal concentration (mg/L)	24 hours			48 hours			72 hours			96 hours
	Surviving	Dead	% mortality	Surviving	Dead	% mortality	Surviving	Dead	% mortality	Surviving	Dead	% mortality
Control 6.0 7.5 9.5 12	10 10 10 6 0	0 0 0 4 10	0 0 0 40 100	10 10 10 3 0	0 0 0 7 10	0 0 0 70 100	10 10 9 3 0	0 0 1 7 10	0 0 10 70 100	9 10 8 3 0	1 0 2 7 10	10 0 20 70 100

Validity criteria fulfilled:

yes

Conclusions:

The 96h-LC50 was determined to be 8.6 mg/L (95% Confidence limit at 7.7 -9.6 mg/L).

Executive summary:

This study was performed according to EU Method C.1 with GLP statement, to assess the acute toxicity of the test substance to fish Cyprinus carpio, under semi-static conditions.

A stability test was performed to measure the concentrations of the test substance in aqueous solution during 72 hours. Results show that the test substance is stable during the test duration.

After a range-finding test, fish were exposed to 4 nominal test substance concentrations (6.0, 7.5, 9.5 and 12 mg/L) with a control medium during 96 hours and the mortality were recorded every day.

The 96h-LC50 was determined to be 8.6 mg/L (95% Confidence limit at 7.7 -9.6 mg/L). The 96h-LC0 and 96h-LC100 were 6.7 and 12 mg/L, respectively.

All validity criteria were fulfilled while mortality in the control was 10% after 96 hours.

Description of key information

EU Method C.1, GLP, key study, validity 1:

96h-LC50 = 8.6 mg/L (95% confidence limit = 7.7-9.6 mg/L).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

8.6 mg/L

Additional information

To assess the short-term toxicity of the registered substance to fish, two studies are available. Among this data, one study is assessed as the key study (Scholz, 1997) and the other study as supporting (Scholz, 1996).

According to the key study, performed according to EU Method C.1 with GLP statement, the fish Cyprinus carpio were exposed to a range of substance concentrations (6.0 to 12.0 mg/L) under semi-static conditions, during 96 hours. The 96h-LC50 based on mortality was determined to be 8.6 mg/L (95% confidence limit at 7.7 -9.6 mg/L).

In the supporting study, solvent was used, the test duration was only 48 hours and no analytical measurements were performed. Furthermore, some information were missing and validity criteria cannot be verified.