2',3-bis[[3-[3,5-di-tert-butyl-4-hydroxyphenyl]propionyl]]propionohydrazide

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

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Non-GLP guideline study without analytics. Tested according to the method reported by Bathe et al. (1974): vehicle: acetone, only 4 fish per concentration group

Qualifier:

according to guideline

Guideline:

other: R. Bathe, K. Sachsse, L. Ullmann, W.D. Hermann, F. ZSk and R. Hess: The evaluation of fish toxicity in the laboratory. In: Proceedings of the Europ. Soc. of Toxicology. Vol. XVI, pp. 113-124, Carlsbad, June 1974

Deviations:

no

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Various concentrations of test item were prepared by adding the test material dissolved in acetone at the appropriate amount ensuring that the total volume in each vessel remained the same. The corresponding volume of acetone was added to the vessels containing the control group.
- Chemical name of vehicle: Acetone

Test organisms (species):

other: Rainbow trout, Carp, Catfish, Bluegill, Golden orfe

Details on test organisms:

TEST ORGANISM
1.
- Common name: Rainbow trout (Salmo gairdneri)
- Source: "Mandli", Liestal, Switzerland, fish breeding station.
- Length at study initiation: 101 mm
- Weight at study initiation: 11.1 g
2.
- Common name: Carp (Cyprinus carpio)
- Source: "Riegger", Ettenheim, W.Germany, fish breeding station.
- Length at study initiation: 71 mm
- Weight at study initiation: 5.8 g
3.
- Common name: Catfish (Ictalurus melas)
- Source: "Weber", Wohlen,Switzerland.
- Length at study initiation: 56 mm
- Weight at study initiation: 2.6 g
4.
- Common name: Bluegill (Lepomis macrochirus)
- Source: "Exotarium Stubenvoll", Allschwil, Switzerland.
- Length at study initiation: 56 mm
- Weight at study initiation: 3.6 g
5.
- Common name: Golden orfe (Leuciscus idus. melanotus)
- Source: "Eggers", Hohenweststedt, W.Germany, fish breeding station.
- Length at study initiation: 76 mm
- Weight at study initiation: 3.1 g

ACCLIMATION
- Acclimation period: 10 days
- Acclimation conditions: Fish were kept in 250 lit. glass tanks containing normal drinking water which was aerated and filtered continuously through a filter bed of activated charcoal.
- Feeding frequency: The fish were fed daily. Prior to testing the food was withdrawn for 3 days.
- Health during acclimation (any mortality observed): Overall mortalities in stocks were well below 10 % and ho deaths occurred during the 10 days prior to testing. All fish were in good condition and free from disease.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

14 +/- 2 °C (trout, carp, bluegill)
22 +/- 2°C (catfish, golden orfe)

pH:

Rainbow trout: 7.2 - 7.3
Carp: 6.5 - 7.3
Catfish: 6.9 - 7.4
Bluegill: 6.7 - 7.4
Golden orfe: 6.7 - 7.3

Dissolved oxygen:

Rainbow trout: not determined
Carp: 3.1 - 10.3 mg/L
Catfish: 5.4 - 10.8 mg/L
Bluegill: 6.0 -11.0 mg/L
Golden orfe: 2.5 - 10.8 mg/L

Nominal and measured concentrations:

37; 49; 65 and 100 ppm

Details on test conditions:

TEST SYSTEM
- Test vessel: glass tanks of 12 litre capacity
- No. of organisms per vessel: four fish in each tank
- Aeration: with exception of experiments on trout the water was not aerated during testing
- Biomass loading rate:
Rainbow trout - 3.7 g/litre
Carpi - 1.9 g/litre
Catfish - 1.0 g/litre
Bluegill - 1.2 g/litre
Golden orfe - 1.2 g/litre

TEST MEDIUM / WATER PARAMETERS
Reconstituted water prepared of deionised water to which salts were added in the following amount per litre:
30 mg calcium sulphate
30 mg magnesium sulphate
48 mg sodium bicarbonate
48 mg sodium bicarbonate
3 mg potassium chloride

Oxygen dissolved in the water and pH were monitored at 24 hour intervalls throughout the 96 hour testing period.

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: for all fish

Details on results:

In all specied no toxicity was observed up to a concentration of 100 mg/L. No toxicity was observed in the control.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

weight of evidence

Justification for type of information:

For the detailed read across justification please refer to the attached pdf file.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Conclusion

Remarks:

No effect is expected in the range of solubility.

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1984-06-25 to 1984-07-02

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study with analytics. Use of vehicle allowed testing of high concentrations well above the limit of water solubility (water solubility = 5-7 µg/L). Vehicle control showed no negative effects.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

adopted 12 May 1981

Deviations:

yes

Remarks:

: vehicle concentration > 100 mg/L (1900 mg/L )

GLP compliance:

no

Analytical monitoring:

yes

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Concentration of vehicle in test medium: 1900 mg DMF; 0.4 mg Marlopon AT50 per L water
- Evidence of undissolved material (e.g. precipitate, surface film, etc): none

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout
- Source: P. Hohler / CH-4314 Zeiningen
- Length at study initiation (length definition, mean, range and SD): 49 mm (47 - 50 mm)
- Feeding during test: none

ACCLIMATION
- Acclimation period: 27 d
- Acclimation conditions (same as test or not): same as test

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

152 mg CaCO3/L

Test temperature:

15 ± 1 °C

pH:

7.9-8.0

Dissolved oxygen:

73 - 98 % (during test)

Nominal and measured concentrations:

nominal: 100 mg/L
actual (geometric mean): 61 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass aquaria of 20 L filled with 15 L (36/22/25 cm)
- Aeration: none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.3 g/L

TEST MEDIUM / WATER PARAMETERS
- Watear: dechlorianted tap water
- Culture medium different from test medium: no
- Intervals of water quality measurement: pH, O2, temperature - daily

OTHER TEST CONDITIONS
- Light: Fluorescent light, 16 h daily

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 61 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

> 61 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 61 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: none
- Mortality of control: none
- Other adverse effects control: none
- Effect concentrations exceeding solubility of substance in test medium: yes

Reference 4

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984-06-25 to 1984-07-02

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study with analytics. Use of vehicle allowed testing of high concentrations well above the limit of water solubility (water solubility = 5-7 µg/L). Vehicle control showed no negative effects.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

adopted 12 May 1981

Deviations:

yes

Remarks:

: vehicle concentration > 100 mg/L (1900 mg/L)

GLP compliance:

no

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 100 mg/L (nominal); 57 mg/L (actual)
- Sampling time: at 0 h and 96 h exposure

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): 1900 mg DMF; 0.4 mg Marlopon AT50 per L water
- Evidence of undissolved material (e.g. precipitate, surface film, etc): none; the test substance appeared homogenously distributed at the test concentration
- Controls: blank and vehicle control

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebrafish
- Source: West-Aquarium / D-3422 Bad Lauterberg
- Length at study initiation (length definition, mean, range and SD): 25 - 33 mm (average: 28 mm)
- Weight at study initiation (mean and range, SD): 0.2 g (0.2 - 0.3 g)
- Feeding during test: none

ACCLIMATION
- Acclimation period: 159 d
- Acclimation conditions (same as test or not): same as test

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

152 mg CaCO3/L

Test temperature:

23 ± 1 °C

pH:

8.0

Dissolved oxygen:

80 - 99 %

Nominal and measured concentrations:

nominal: 100 mg/L
actual (geometric mean of measured concentrations at 0 h and 96 h): 57 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass aquaria of 20 L filled with 15 L (36/22/25 cm)
- Aeration: none
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.2 g/L

TEST MEDIUM / WATER PARAMETERS
- Watear: dechlorianted tap water
- Culture medium different from test medium: no
- Intervals of water quality measurement: pH, O2, temperature - daily

OTHER TEST CONDITIONS
- Light: Fluorescent light, 16 h daily

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 57 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

> 57 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 57 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: none
- Mortality of control: none
- Mortalities vehicle: 10%
- Other adverse effects control: none
- Effect concentrations exceeding solubility of substance in test medium: yes

Description of key information

With high probability acutely not harmful to fish. 

Additional information

The short-term toxicity to fish was assessed in a weight of evidence approach using two studies from a structural analogue and a study on the substance itself. The reliability of study on the substance itself was not assignable. It was conducted according to the method by Bathe et al. (1974). The LC50 was determined to be > 100 mg/L. The studies on the structural analogue did not cause toxic effects in the range of water solubility. It can therefore be concluded that the target compound is not acutely harmful to fish.

A detailed read across justification can be found in the respective endpoint study record.