Pentapotassium bis(peroxymonosulphate) bis(sulphate)

Toxicity to birds

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to birds: acute oral toxicity test

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2007-02-23 - 2007-04-27

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was terminated ahead the schedule and no reliable results could be derived (see results). However, with respect to the characteristics of the test item and due to animal welfare concerns, it seems to be not possible to perform a reliable dietary study in birds. The study was therefore not repeated.

Qualifier:

according to guideline

Guideline:

OECD Guideline 205 (Avian Dietary Toxicity Test)

Version / remarks:

1984

Deviations:

yes

Remarks:

see under "Principles of method if other than guideline"

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.2100 (Avian Acute Oral Toxicity Test)

Version / remarks:

1996

Deviations:

yes

Remarks:

see under "Principles of method if other than guideline"

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.2200 (Avian Dietary Toxicity Test)

Deviations:

yes

Remarks:

see under "Principles of method if other than guideline"

Principles of method if other than guideline:

The study was terminated after one day due to animal welfare concerns. An acidic solution (pH~1) was created when KMPS triple salt was dissolved in deionized water, which is below the normal pH range of the digestive tract of birds, leading to acidic burns in the upper digestive tract. The dosing solutions were therefore buffered, however, KMPS triple salt could not be maintained in the dosing solution.

GLP compliance:

yes

Dose method:

gavage

Analytical monitoring:

yes

Vehicle:

no

Details on preparation and analysis of diet:

Each dosing solution was sampled at 15 seconds intervals while solution was mixed. Three samples were taken from each concentration. Samples were processed immediately.
Samples were analysed using titration method. Concentrations were quantified by iodometric titration using 0.001N sodium thiosulphate solution.

Test organisms (species):

Colinus virginianus

Details on test organisms:

TEST ORGANISM
- Species/strain: Northern Bobwhite (Colinus virginianus)
- Source: Wildlife international production flock
- Age at test initiation: hatchlings, 14 days old
- Weight at test initiation: 28 – 35 g
- Sexes used: sexually immature
- Breeding population: pen-reared

Limit test:

no

Total exposure duration (if not single dose):

1 d

Remarks:

test was terminated due to animal welfare concerns and instability of test substance in diet

Post exposure observation period:

not indicated

No. of animals per sex per dose and/or stage:

not indicated

Control animals:

yes

Nominal and measured doses / concentrations:

Nominal: 356, 633, 1124, 2000, 3556 mg KMPS triple salt/ kg bw, corresponding to 16.0, 28.5, 50.6, 90.0, 160 mg KHSO5/mL
Measured: 0.1, 4.8, 16.4, 10.6, 1.63 mg KHSO5/mL

Details on test conditions:

ACCLIMATION
- Acclimation period: 14 days of acclimatisation from day of hatch until test initiation

PEN SIZE AND CONSTRUCTION MATERIALS
- Description: Indoor in batteries of thermostatically controlled brooding pens with floor space measuring 72 x 90 cm, height of 23 cm. Walls, ceilings and floors made if wire mesh and/or galvanised sheeting

NO. OF BIRDS PER PEN: 5

NO. OF BIRDS PER REPLICATE
- For control: 30
- For treated: 10

NO. OF REPLICATES PER DOSAGE LEVEL: 2

TEST CONDITIONS (range, mean, SD as applicable)
- Temperature:
- Brooder temperature: 39°C
- Awerage ambient room temperature: 27.5±0.9°C
- Relative humidity: 22±2%
- Photoperiod: 16 h light
- Ventilation: 15 room air volumes every hour, air was replaced with fresh air
- Shielding: Not reported

DIET DURING TEST: game bird ration, water soluble vitamin mix, water

DOSING VOLUME PER APPLICATION: 10 mL dosage volume / kg bw

Details on examinations and observations:

Frequency, duration and method of animal monitoring after dosing:
Daily observations during acclimatisation, following dosing three observations, once prior to test termination.
Due to lack of mortality no gross necropsy was performed.

Time and intervals of body weight determination:
Test initiation

Details on reproductive parameters:

not indicated

Reference substance (positive control):

no

Key result

Dose descriptor:

LC50

Remarks on result:

not determinable

Mortality and sub-lethal effects:

No mortality was observed

Effects on reproduction:

Not applicable

Results with reference substance (positive control):

Not applicable

Further details on results:

Body weight was not reported.
Feed consumption was not reported.

Reported statistics and error estimates:

No statistics was performed, as test was completed ahead of schedule.

NA

Validity criteria fulfilled:

yes

Conclusions:

The study was terminated ahead the schedule and no LC50 could be calculated (see results).

The toxicity of KMPS triple salt towards the Northern Bobwhite (Colinus virginianus) was evaluated in a study according to US EPA guidelines 850.2100 and 850.2200 and according to OECD 205. Due to the instability of the test substance, oral gavages were selected as exposure route. The study was terminated ahead schedule.

Executive summary:

Materials and methods

The toxicity of KMPS triple salt towards the Northern Bobwhite (Colinus virginianus) was evaluated in a study according to US EPA guidelines 850.2100 and 850.2200 and according to OECD 205. Due to the instability of the test substance, oral gavages were selected as exposure route. The study was terminated ahead schedule.

 

Results and discussion

The dietary LC50 study for Northern Bobwhite exposed to KMPS triple salt was terminated after 1 day of exposure. When dissolved in deionised water to prepare dosing solutions, KMPS triple salt creates an acidic solution, below the normal pH range of the digestive tract of birds. Animal welfare concern prohibited the dosing of an acidic solution that would be certain to cause acid burns in the upper digestive tract. Therefore, the dosing solutions were buffered prior dosing. Subsequent analysis revealed that with buffering KMPS could not be maintained in solutions. The study was therefore terminated.

 

LD50      : was not calculated due to lack of mortality  

Description of key information

The acute toxicity to birds of KMPS triple salt was investigated in an Avian dietary toxicity test according to the OECD Guideline 205. The study was terminated after 1 day of exposure. 

Additional information

Toxicity to birds

The dietary LC50 study for Northern Bobwhite exposed to KMPS triple salt was terminated after 1 day of exposure. When dissolved in deionised water to prepare dosing solutions, KMPS triple salt creates an acidic solution, below the normal pH range of the digestive tract of birds. Animal welfare concern prohibited the dosing of an acidic solution that would be certain to cause acid burns in the upper digestive tract. Therefore, the dosing solutions were buffered prior dosing. Subsequent analysis revealed that with buffering KMPS triple salt could not be maintained in solutions. The study was therefore terminated.

Data Waiver: Toxicity to birds

In accordance to section 9.6.1, column 2 of Annex X, reproductive toxicity test to birds does not need to be conducted as a mammalian dataset is available (see toxicological studies) In addition direct and indirect exposure of the soil compartment is unlikely. The substance has no high potential to adsorb to soil and is not very persistent. According to the available information of the toxicity test to Eisenia fetida, no toxicity effect could be observed (LC50 > 1000 mg KMPS triple salt/ L). This result shows that KMPS triple salt has a very low acute toxicity to earthworms (IUCLID section 6.3.1). As there are no other indications of concern for the terrestrial compartment, further testing to terrestrial arthropods is considered to be scientifically not justified.