N,N'-propane-1,3-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide]

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:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

Additional documentation, provided within the IUCLID Assessment Reports (Section 13), supports the read-across approach.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Stock: 10.0 g of test substance was mixed with 398 mg alkylphenol-polyglykol-ether and made up to 25 mL with DMF.
- Controls: Blank: water
Vehicle: 151 mg DMF and 4 mg alkylphenol-polyglykol-ether per litre water in the concentration used for the test concentration

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra Fish
- Strain: Danio rerio
- Source: West Aquarium / D-3422 Bad Lauterberg
- Length: 24 mm (19-27 mm)
- Weight: 0.12 g (0.05-0.17 g)

ACCLIMATION
- Acclimation period: 19 days

Test type:

static

Water media type:

other: Dechlorinated tap water

Limit test:

yes

Total exposure duration:

96 h

Hardness:

180 mg CaCO3/L

Test temperature:

23 ± 1°C

pH:

8.1 to 8.4

Nominal and measured concentrations:

Nominal: 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass aquaria of 20 liter filled with 15 liters (36/22/25 cm)
- Aeration: None
- No. of fishes per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.08 g/L

OTHER TEST CONDITIONS
- Photoperiod: Fluorescent light, 16 hours daily

EFFECT PARAMETERS MEASURED: Swimming behaviour, loss of equilibrium, respiratory function, exophtalamus and pigmentation at 24, 48, 72, and 96 h

Reference substance (positive control):

no

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)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: None
- Mortality of control: None
- Abnormal responses: None

Validity criteria fulfilled:

yes

Conclusions:

96 h LC50: >100 mg/L (Brachydanio rerio)

Executive summary:

The acute toxicity of the test substance to unfed Zebra fish (Brachydanio rerio), was determined in an unaerated, 96-hour test conducted in accordance with the Test Guideline OECD 203. The test was performed as limit test at a concentration of 100 mg/L nominal. Two test chambers was maintained in the treatment group, with 10 fish per aquarium and 10 fish tested as control. Observations of mortality and other signs of toxicity were made at approximately 24, 48, 72 and 96 hours after test initiation.

The 96-hour LC50 for zebra fish based on nominal concentrations of the test substance and mortality was greater than 100 mg/L.

Description of key information

No acute fish toxicity study with the test substance is available. A study in accordance with OECD Guideline 203 with N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenylpropionamide] was used as read across to fulfil the data gap for the test substance. The underlying hypothesis supporting read-across from the source (N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenylpropionamide]; CAS 23128-74-7) to the target (N,N'-propane-1,3-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide]; CAS 69851-61-2) includes the following: (1) Structural similarity, (2) Source and target are expected to hydrolyse in a similar fashion, (3) Source and target have similar predicted metabolism, (4) Source and target have similar physicochemical properties, (5) Source and target have similar calculated chemical descriptors, and (6) Source and target have similar predictions for the endpoints of concern. Additional documentation, provided within the IUCLID Assessment Reports section, supports the read-across approach.

The acute toxicity to unfed Zebra fish (Brachydanio rerio), was determined in an unaerated, 96-hour limit test at a nominal concentration of 100 mg/L. Two test chambers were maintained in the treatment group (10 fish per aquarium), and 10 fish were tested as control. The 96-hour LC50 for zebrafish was >100 mg/L, based on nominal concentrations of the test substance and mortality.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L