Iron digluconate

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:

comparable to guideline study

Qualifier:

according to guideline

Guideline:

other: PARCOM method 1995

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Details on sampling:

Photoperiod: Ambient laboratory lighting with a daily 10 hour photoperiod.

Aeration: Air bubbled directly into test media.

Details on test solutions:

Dilution media: Artificial seawater (Coral Ree[ Kent Sea Salt, Red Sea Fish Pharm).

Test organisms (species):

other: Scophthalmus mamimus (Juvenile turbot)

Details on test organisms:

Juvenile turbot were received on 19 October 2000 free of malformations and in good health and assigned a batch number of SM00009.

Supplied by Mannin Sea Farms, Derbyhaven, Isle of Man.

Animals were fed and maintained as detailed in STL Runcorn SOP 1.16. Stock juvenile turbot were held in artificial seawater (STL Runcorn SOP 111.12)
maintained at 15 ± 2°C by a chiller unit and aerated via air diffusers attached to the laboratory air supply system. Feeding was stopped when juvenile turbot were transferred to test tanks 24 hours before the start of the tests.

Test type:

semi-static

Water media type:

saltwater

Total exposure duration:

96 h

Post exposure observation period:

Animals were observed twice every 24 hours. Numbers of mortalities and animals exhibiting abnormal behaviour were recorded. At the end of the test a sample of juvenile turbot was weighed and measured. The mean values and standard deviations were calculated and recorded.

Hardness:

No data

Test temperature:

Ranged from 13.3-15.1 C

pH:

Mean ranged from 6.92 to 8.16

Dissolved oxygen:

Mean Ranged from 79.7 to 95.4 %

Salinity:

Ranged from 31.5-33.0

Nominal and measured concentrations:

Nominal concentrations of the test solution of 100.0, 177.8, 316.2, 562.3 and 1000.0 mg/L were prepared in artificial seawater

Details on test conditions:

Single replicates of 10 litres at each test concentration and control media were prepared. Seven animals were added to each test vessel and exposures conducted under semi-static conditions with replacement of media every 24 hours. Test duration was 96 hours at a nominal temperature of 15 ± 2°C.

Exposures were conducted between 6 November and 10 November 2000.

Reference substance (positive control):

yes

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

> 1 000 mg/L

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

1 000 mg/L

Basis for effect:

mortality (fish)

Details on results:

All animals in the control vessels survived the 96 hour test period. After 96 hours exposure to the test material, the LC50 was determined to be > 1000.0 mg/L. The the LC50 values after 24, 48 and 72 hours were also determined to be > 1000.0 mg/L in this study. The concentration of test material producing No Observable Effect, (NOEC). was determined to be 1000.0 mg/L after 96 hours. The concentration of test material producing the Lowest Observed Effect, (LOEC), could not be determined. None of the concentrations tested produced 100% mortality in this study.

Reported statistics and error estimates:

The mortality data calculated at each observation period is usually proccessed using the statistical computer programme Toxcalc, supplied by Tidepool Scientific (STL Runcorn SOP V .1 ). Toxcalc is used to derive the median effect concentration (LC50) which kills (immobilises) 50% of the animals exposed to the test material, together with 95% fiducial limits and a No Observed Effect Concentration (NOEC). However, the data was deemed unsuitable for such analysis in this case.

Sublethal observations / clinical signs:

After 96 hours exposure to concentrations of the test substance, the LC₅₀ was determined to be > 1000.0 mg/L in this study. None of the concentrations tested produced 100% mortality in this study.

Throughout the study tanks at concentrations of 316.2, 562.3, and 1000.0 mg/L were observed to have pH values lower than the acceptable control limits. The pH for these concentrations was not altered to within acceptable control tolerance levels. This was in compliance with the test guidelines, which recommend that the test should be carried out without adjustment of the pH. The pH values did not effect the overall test result, as the LC₅₀ was greater than the higher concentration tested.

It was also observed that the DO values were lower than the acceptable control limits in new tanks at concentrations of 316.2, 562.3 and 1000.0 mg/L. However, new airlines were introduced before the addition or the test organisms.

Conclusions:

The 96 hour LC50 value was determined to be > 1000.0 mg/L for iron gluconate to juvenile turbot. The NOEC was 1000 mg/L for exposures of iron gluconate to juvenile turbot.

Iron Gluconate is classified as non-hazardous for this end point

Executive summary:

In study STL001005, a sample of iron gluconate was assessed for its potential toxicity to juvenile turbot in a semi-static test over 96 hours in accordance with the PARCOM method 1995, OECD guideline 203 and as detailed in STL Runcorn SOP ITT .6. Test concentrations were prepared over the range of 100.0 mg/L to 1000.0 mg/L. Juvenile turbot were exposed to the test concentrations in order to determine the concentration which killed 50% of the test organisms over 96 hours (LC₅₀). From this study the 96 hour LC₅₀ value was determined to be > 1000.0 mg/L. The 24, 48 and 72 hour values were also determined to be > l000 mg/L from this study.

Iron Gluconate is classified as non-hazardous for this end point

Description of key information

A sample of iron gluconate was assessed for its potential toxicity to juvenile turbot in a semi-static test over 96 hours in accordance with the PARCOM method 1995, OECD guideline 203 and as detailed in STL Runcorn SOP ITT .6. Test concentrations were prepared over the range of 100.0 mg/L to 1000.0 mg/L. Juvenile turbot were exposed to the test concentrations in order to determine the concentration which killed 5O% of the test organisms over 96 hours (LC50). From this study the 96 hour LC50 value was determined to be > 1000.0 mg/L. The 24, 48 and 72 hour values were also determined to be > 1000 mg/L from this study.
Iron Gluconate is classified as non-hazardous for this end point

Key value for chemical safety assessment

Marine water fish

Marine water fish

Effect concentration:

1 000 mg/L