Pyridoxine hydrochloride

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:

5-31 October 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted according to OECD Guidelines and in compliance with GLP principles. Although no details are included in the report on analytical validation, the method is deemed sufficiently validated as documented in the report of the Daphnia magna acute toxicity test (Ciba 928379, reliable with restrictions based on lack of detailed method validation results).

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1984

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Composite samples (about 150 mL in duplicate) of each test concentration were drawn by mixing identical volumes of the test solutions taken from the approximate center of the test vessels. They were taken immediately before exposure and after 96 hours exposure and kept at - 18 ºC to - 22 ºC until analysis.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: calculated amounts of the stock solution (7.5 g test substance with 1000 mL water) to produce the desired test concentrations were homogeneously distributed into the water. The solutions were homogenuous at all test times and test concentrations.

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 (mean): 51 mm (47-54 mm) based on 10 fishes
- Weight at study initiation (mean): 1.25 (0.94-1.59 g) based on 10 fishes
- Method of breeding: not reported
- Feeding during test: none

ACCLIMATION
- Acclimation period: 48 days
- Adaptation: 24 hours/no food 24 hours prior to exposure

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

168 mg CaCO3/L

Test temperature:

15 ºC

pH:

At the start: 7.3 - 7.6
Day 1 - Day 4: 8.0 - 8.2

Dissolved oxygen:

84 - 107% of the air saturation value (no raw data reported).

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal: 10, 18, 32, 58, and 100 mg/L
Measured: see table below. The measured concentrations were within ± 20% of nominal concentrations at the start and end of the test. The effect concentrations were reported as nominal concentrations, which is acceptable.

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass aquaria of 20 L filled with 15 L
- size: 36/22/25 cm
- Aeration: gentle aeration during exposure
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- Biomass loading rate: 0.42 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated tap water

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light
- Light intensity: Fluorescent light

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortalities after 24, 48, 72 and 96 hours; daily examination for symptoms of swimming behaviour, loss of equilibrium, respiratory function, exoophtalmus and pigmentation

TEST CONCENTRATIONS
- Spacing factor for test concentrations:1.8
- Range finding study: conducted but not reported

Reference substance (positive control):

no

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:

No mortalities or other symptoms were observed in any of the treatments.

Results with reference substance (positive control):

None

Reported statistics and error estimates:

None

Validity criteria fulfilled:

yes

Conclusions:

The 96h-LC50 of the test substance was > 100 mg/L (based on analytically confirmed nominal concentrations).

Executive summary:

In a 96h acute toxicity study conducted according to OECD 203, rainbow trout (Oncorhynchus mykiss) were exposed to Pyridoxin-HCl under static conditions at the following nominal concentrations: blank-control, 10, 18, 32, 56, 100 mg/L. Test substance induced no visible or lethal effects in the fish at any of the concentrations tested. The 96 h LC50 was >100 mg/L based on analytically confirmed nominal concentrations. Although no details were included in the report on analytical validation, the method is deemed sufficiently validated as documented in the report of the Daphnia magna acute toxicity test (Ciba 928379, reliable with restrictions based on lack of detailed method validation results). The short-term toxicity test to rainbow trout is therefore considered to be also reliable with restrictions.

Description of key information

In a 96h acute toxicity study conducted according to OECD 203, rainbow trout (Oncorhynchus mykiss) were exposed toPyridoxin-HClunder static conditions at the following nominal concentrations: blank-control, 10, 18, 32, 56, 100 mg/L. Test substance induced no visible or lethal effects in the fish atany of the concentrations tested.The 96 h LC50 was >100 mg/L based on analytically confirmed nominal concentrations.Although no details were included in the report on analytical validation, the method is deemed sufficiently validated as documented in the report of the Daphnia magna acute toxicity test (Ciba 928379, reliable with restrictions based on lack of detailed method validation results). The short-term toxicity test to rainbow trout is therefore considered to be also reliable with restrictions.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L