(R)-α-phenylethylammonium (-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate

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

Study period:

July 18, 1994 - July 22, 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 100 mg/l
- Sampling method: sample removed at 24 hours from the treatment concentration. The sample was analysed for Fosfomycin PEA salt by Istituto G. Donegani.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test solution of Fosfomycin PEA salt were prepared by dissolving weighed amounts of test article directly to the study tanks in order to obtain the requested concentration.
- Differential loading: maximum loading was lower than 1.0 g fish/l (about 0.385 g/l)
- Controls: Yes, only water (0 mg/l)

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Source: "AQUA 1", Piazza Pistoni 10, 10015 IVREA (Torino, Italy)
- Length at study initiation (length definition, mean, range and SD): 3 cm (average value)
- Weight at study initiation (mean and range, SD): 0.385 g (average value)

ACCLIMATION
- Acclimation period: 2 weeks before start of the test.
- Type and amount of food: Mangime SERA
- Feeding frequency: daily until 24 hours before test
- Health during acclimation (any mortality observed): no mortality was recorded after 7 days of acclimation.
- Water source: municipal water main system
- Temperature: 23 ºC
- pH: 7.1
- Hardness: 39 mg/l CaCO3
- O2 concentration: 8.1 mg/l
- Parameter controls: immediately before the arrival of the fish and periodically (microbiologic count, heavy metals and other physico-chemical characteristics).

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

39 mg/l CaCO3

Test temperature:

24-25 ºC

pH:

6.56 - 7.14

Dissolved oxygen:

8.0 - 8.2 mg/l

Nominal and measured concentrations:

Nominal concentrations: 0 (control) and 100 mg/l
Measured concentrations: 95.22 mg/l (24 h - nominal concentration of 100 mg/l)

Details on test conditions:

TEST SYSTEM
- Test vessel: Tanks
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: Makrolon, 48x27x20 cm, 5 liters
- Aeration: No (to avoid foaming)
- Renewal rate of test solution (frequency/flow rate): Every 24 hours
- No. of organisms per vessel: 7 animals
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: municipal water main system
- Periodically, the water was analyzed for microbiologic count, heavy metals and other chemical and physical characteristics.

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16/8 hours light/dark daily.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
Observation of mortality: the fish were inspected after 24, 48, 72 and 96 hours. Fish were considered dead if touching of the caudal peduncle produced no reactions.
Observation of visible abnormalities: effects observed in the appearance, size and behaviour of the fish that make them clearly distinguishable from the control animals.

TEST CONCENTRATIONS
- Test concentrations: 0 (control) and 100 mg/l

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)

Details on results:

- Behavioural abnormalities: No animals of the control and treated groups showed visible signs of abnormalities.
- Observations on body length and weight: No animals of the control and treated groups showed visible signs of abnormalities.
- Other biological observations: No animals of the control and treated groups showed visible signs of abnormalities.
- Mortality of control: No animals of the control and the treated groups died
- Abnormal responses: No animals of the control and treated groups showed visible signs of abnormalities.

Sublethal observations / clinical signs:

Table 1. Acute toxicity study in fish (semi-static test). Parameter: dissolved oxygen – pH- Temperature.

Conc. 0 mg/L (control group)
Hours	Dissolved O2 (mg/L)	pH	T (ºC)
0	8.2	7.06	24
24*	8.0	7.00	25
24**	8.1	7.08	24
48*	8.0	7.00	24
48**	8.2	7.06	24
72*	8.0	7.00	24
72**	8.1	7.05	24
96	8.0	7.00	24
Conc. 100 mg/L (test item)
Hours	Dissolved O2 (mg/L)	pH	T (ºC)
0	8.2	6.49	24
24*	8.0	7.12	25
24**	8.1	6.57	25
48*	8.0	7.12	24
48**	8.2	6.56	24
72*	8.0	7.10	24
72**	8.1	6.56	24
96	8.0	7.14	24

* before water renewal; ** after water renewal.

Validity criteria fulfilled:

yes

Remarks:

No mortality was observed by the end of the test control, the conditions were constant during the test, the dissolved oxygen concentration was in the acceptable range, the substance concentration was maintained during the test.

Conclusions:

LC50 (based on mortality) of test material in Brachydanio rerio at 96 h exposure period was > 100 mg/l.

Executive summary:

The acute toxicity of test material to the Brachydanio rerio, was determined in a 96 -hour, semi-static, aquatic (freshwater) effect test according to EU Method C.1. A total of 7 fish were exposed to 0 (control) and 100 mg/l nominal concentrations (limit test). The animals were treated and observed for 96 hours. No animals in the control group died or showed signs of visible abnormalities. No animals of the treated group died. The LC50 values at 24, 48, 72 and 96 hours were not calculated.

Description of key information

Key study: Test method according to EU Method C.1. GLP study.

LC50 (based on mortality) of test material in Brachydanio rerio at 96 h exposure period was > 100 mg/l.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

Key study: Test method according to EU Method C.1. GLP study. LC50 (based on mortality) of test material in Brachydanio rerio at 96 h exposure period was > 100 mg/l.