(6S,7S)-7-Amino-3-(methoxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid

Short-term toxicity to fish

Link to relevant study record(s)

Reference

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: Guideline study with GLP.

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Actual concentrations of the test substance in the test media were determined immediately before placing the fish in the test vessels and then after approximately 4, 24 and 96 hours.

Vehicle:

no

Details on test solutions:

Test medium was used to prepare the test substance solution.
Dilution water: Local tap water was mixed 1:1 with deionized water to achieve the appropriate water hardness of 250 mg CaCO3/L, determined in the control vessel.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Species: Zebrafish (Brachydanio rerio)
Supplier: Amazonas Aquarium, A-2840 Grimmenstein, Austria
Receipt of animals: 17 May 2000. Batch of 107 animals.
Length (cm): Approximately 2.8 cm (mean of the control group at the end of study).

Animal maintenance during acclimatisation and during exposure:
Water: Dilution water for holding and exposure
Aeration: Holding: continuous aeration by compressed air (water and oil filtered) and additional aeration by water recirculation using an EHEIM 2211 filter pump. Exposure: no aeration.
Temperature: Holding: ca. 21 °C. Exposure: 21 °C.
Tanks: Holding: full glass vessel (47 cm x 29 cm x 31 cm}, filled with ca. 30 L, covered with a transparent plastic lid. Water was purified by recirculation (power filter pump EHEIM 2211) through filter wool. Exposure: full glass vessels (29 cm x 20 cm x 24 cm}, filled with 6 litres of control or test medium, covered with transparent plastic lids.
Light: Artificial light from 4 a.m. to 8 p.m.
Maintenance control during holding: Temperature: daily. Oxygen, pH: approximately once a week.
Mortality during holding: < 1% /week.
Feeding: Feed: TetraMin; Tetra Werke, Dr.rer.nat. Ulrich Baensch GmbH, D-49304 Melle. Holding: daily. Exposure: no feeding (last feeding about 24 hours before the start of the exposure).
Acclimatisation period: Approximately 4 months.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

n.a.

Hardness:

250 mg CaCO3/L.
Local tap water was mixed 1:1 with deionized water to achieve the appropriate water hardness of 250 mg CaCO3/L, determined in the control vessel.

Test temperature:

21 °C

pH:

7.8 - 8.0 in the test group.
7.5 - 8.1 in the control group.

Dissolved oxygen:

82 to 88 % in the test group.
88 to 98 % in the control group.

Salinity:

n.a.

Nominal and measured concentrations:

Nominal: 100 mg/L.
Actual, mean: 99.4 mg/L at 0 h; 98.9 mg/L at 4 h; 99.6 mg/L at 24 h; 95.8 mg/L at 96 h.

Details on test conditions:

7 fish were used per group.

Reference substance (positive control):

not required

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

72 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:

LC50

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)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

Mortality
Negative control group: All animals survived until the end of the test.
Test substance group: All animals survived until the end of the test.

Animal observation
All animals of the test substance group and of the negative control group were inconspicuous in behaviour and appearance until the end of the test.

Results with reference substance (positive control):

n.a.

Reported statistics and error estimates:

n.a.

Sublethal observations / clinical signs:

Quality criteria

The conditions for the validity of the test were fulfilled:

• Constant conditions were maintained (temperature, pH).

• No mortality occurred in the negative control group.

• The dissolved oxygen concentration was higher than 60 % of the air saturation value throughout the test.

• The concentration of the test substance has been satisfactorily maintained over the test period (higher than 80 % of the appropriate starting concentration in the test medium).

Validity criteria fulfilled:

yes

Conclusions:

The LC50,96h is higher than 100 mg/L.

Executive summary:

The acute toxicity of 7-AMCA to Zebrafish (Brachydanio rerio) was determined in a 96 hours static test according to the EC-method C.1. A limit test with 100 mg test substance/L was performed. 7 fish (length of approximately 2.8 cm) were used for each of the test substance group and the control group.

Results:

No mortality and no adverse effects were noted in the test substance group and in the negative control group. The measured concentrations of 7-AMCA in the test medium ranged from 95.8 mg/L to 99.6 mg/L.

pH and temperature were stable throughout the test period. Dissolved oxygen concentration was always higher than 82 % of the air saturation value at the appropriate temperature.

The LC50,96h is higher than 100 mg/L.

Description of key information

The LC50,96h for Brachydanio rerio is higher than 100 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

The LC50 is not 100 mg/L, as one is forced to enter in the field above, but the LC50 is >100 mg/L.