Potassium pentahydrogen bis(phosphate)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Remarks:

In vivo. Study was performed prior to the update of the REACH Regulation and prior to the validation of in vitro test methods.

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From: 19/04/2006 To: 22/04/2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(2002)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

(1998)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Part B.4 (Skin Irritation), Directive 2004/73/EC (2004)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Potassium pentahydrogen bis(phosphate)

EC Number:

238-961-5

EC Name:

Potassium pentahydrogen bis(phosphate)

Cas Number:

14887-42-4

Molecular formula:

H 5 K O 8 P 2

IUPAC Name:

potassium pentahydrogen diphosphate

Constituent 2

Reference substance name:

231-961-5

IUPAC Name:

231-961-5

Details on test material:

- Name of test material (as cited in study report): PeKacid
- Substance type: White crystalline powder, Granulometry: 0.5 + 1.00 mm 97%
- Physical state: Solid
- Analytical purity: 59.0% P2O5, 21.8% K2O,
- Impurities: 0.15 ppm Cd, 0.50 ppm As, <10 ppm Heavy metals
- Purity test date: 03/08/2006
- Lot/batch No.: Lot #0001,
- Lab reference #: 060215-3H
- Storage condition of test material: Room temperature
- Other:
Receipt of test material: Received 14/02/2006

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Robinson Services, Inc. Clemmons, NC on April 12, 2006.
- Age at study initiation: The animals are described as young adult rabbits
- Weight at study initiation:
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors. Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum):Filtered tap water was supplied ad libitum by an automatic water dispensing system.
- Acclimation period: 7 days
- Other: 1 male and 2 females were tested. Females assigned to test were nulliparous and non-pregnant.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs light/ dark cycle.


IN-LIFE DATES: From: 12/04/2006 To: 22/04/2006

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.56 gram
- Concentration (if solution): 90% w/w

VEHICLE
- The vehicle was distilled water
- A dry paste was formed.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours after removal of patches containing the test material.

Number of animals:

Three (1 male and 2 females)

Details on study design:

TEST SITE
The test material (moistened to a 90% w/w aqueous suspension) was placed on a 1"x1", 4-ply gauze pad and applied to one 6cm² intact dose site on each animal. The pad and the entire trunk of the animal were then wrapped with semi-occlusive 3-inch micropore tape. Elizabethan collars were placed on each rabbit.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The pads and collars were removed and the test sites were gently cleansed of any residual test substance.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize, J.H., Woodard, G. and Calvery, H.O. Methods for the study of irritation and toxicity of susbtances applied topically to the skin and mucous membranes. J. Pharm. Exp. Ther. 1944; 82:377-390.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hrs

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

other: all animals tested

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

See Tables 1 and 2.
Within one hour after patch removal, all three treated sites exhibited very slight erythema. The overall incidence and severity of irritation decreased with time. All animals were free of dermal irritation by 48 hours.

Other effects:

None - all animals appeared active and healthy during the study.

Any other information on results incl. tables

Table 1 - Individual skin irritation scores

Results given in the format 'erythema/edema'

Animal #	Sex	Time after patch removal
		30-60 min	24 hrs	48 hrs	72 hrs
16475	F	1/0	1/0	0/0	0/0
16476	M	1/0	0/0	0/0	0/0
16477	F	1/0	0/0	0/0	0/0
Total		3/0	1/0	0/0	0/0
Mean		1.0/0	0.3/0	0/0	0/0

Table 2: Summary of primary skin irritation scores (average value for three rabbits)

	Time after patch removal
Erythema	1.0	0.3	0	0
Edema	0	0	0	0
Total (PDI)^a	1.0	0.3	0	0

^a– PDI = Average Erythema + average Edema

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The author reports that under the conditions of this study, PeKacid is classified as slightly irritating to the skin according to U.S. EPA Addendum 3 on data reporting to pesticide assessment guidelines; Dermal Irritation, January 1988.

This study has been selected as the key study because the results are sufficient in order to derive a reliable conclusion on classification and labelling.
In accordance with Regulation (EC) No1272/2008 (EU CLP). Potassium pentahydrogen bis(phosphate) is not considered to be irritating to the skin.