Bis(cyclohexyl)ammonium(2S)-2-{[(benzyloxy)carbonyl]amino}-3,3-dimethylbutanoate

Short-term toxicity to fish

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:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

478-250-9

EC Name:

-

Cas Number:

62965-37-1

Molecular formula:

C26H42N2O4

IUPAC Name:

(2S)-2-{[(benzyloxy)carbonyl]amino}-3,3-dimethylbutanoic acid; N-cyclohexylcyclohexanamine

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

The test concentrations of VRT-126017 dcha were measured using an LC-MS method of analysis. Four, mid-vessel samples (10 ml) of media were
taken from the control and test media at 0 and 72 hours (fresh media) and at 24 and 96 hours (expired media) for analysis.

Test solutions

Vehicle:

yes

Test organisms

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout (Oncorhynchus mykiss)
- Length at study initiation: 6.88 cm
- Feeding during test: no

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions: temperature 13.9-14.3°C, pH 7.65-7-98, dissolved oxygen 92-96%, total hardness 132-170 mg/L as CaCO3
- Type and amount of food: commercial fish food (TROUW (UK) Ltd; Nutra Trout Fry 02) an amount equivalent to between 0.75 and 1.0% of the total wet-weight of fish
- Feeding frequency: daily
- Health during acclimation (any mortality observed): No medication was given during the holding period, and mortalities were recorded as <1.0%
in the 14 days before the definitive test.

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test conditions

Hardness:

152-164 mg/L as CaCO3

Test temperature:

14.2-15.7°C

pH:

7.67-8.38

Dissolved oxygen:

91-108%

Nominal and measured concentrations:

nominal 4.27, 9.39, 20.7, 45.5 and 100 mg/L
measured 4.16, 10.1, 20.9, 45.4 and 88.5 mg/L

Details on test conditions:

Groups of seven juvenile fish were exposed to VRT-126017 dcha, dissolved in water at nominal concentrations of 4.27, 9.39, 20.7, 45.5 and
100 mg/l. The test media were prepared by direct addition of the test substance to water; to aid dissolution, ultrasound treatment (30 minutes) was
employed.

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

58.9 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

58.9 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 3

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

58.9 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 4

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

58.9 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 5

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

88.5 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 6

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

4.16 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Applicant's summary and conclusion

Conclusions:

The 96-hour LC50 value for VRT-126017 dcha with rainbow trout was 58.9 mg/l, with 95% confidence limits of 39.6 and 107 mg/l.
The “no observed effect concentration” was considered to be 4.16 mg/l.