Phosphoric acid, potassium salt (2:3), dihydrate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study Analytical purity not given, responsibility of the sponsor.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Analytical purity not reported, responsibility of the sponsor

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom, 2009

Test material

Test material information

Constituent 1

Reference substance name:

tripotassium trihydrogen phosphate dihydrate

EC Number:

700-282-1

Cas Number:

66922-99-4

Molecular formula:

H304P.H20.3/2K

IUPAC Name:

tripotassium trihydrogen phosphate dihydrate

Details on test material:

- Name of test material (as cited in study report): HiPeaK
- Physical state: white powder
- Analytical purity: not given, responsibility of the sponsor
- Lot/batch No.: 9086
- Storage condition of test material: RT in the dark under nitrogen

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories Ltd., UK
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2.03 - 2.50 kg
- Housing: individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL corresponding to 92 mg (as measured by gently compacting the required volume into an adapted syringe)

Duration of treatment / exposure:

Single treatment without washing

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of three animals

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of three animals

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24, 48 and 72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24, 48 and 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24, 48 and 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48 and 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24, 48 and 72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24, 48 and 72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 h

Other effects:

No systemic toxicity, abnormal body weight changes or clinical signs were observed during the study period.

Any other information on results incl. tables

Table 1: Individual scores

Rabbit No. / sex	Scoring [h]	Cornea	Iris	Conjunctiva
				Redness	Chemosis
1	1	0	0	2	2
	24	0	0	1	1
	48	0	0	1	0
	72	0	0	0	0
	168	0	0	0	0
	Mean 24-72 h	0	0	0.66	0.33
2	1	0	0	2	2
	24	0	0	1	1
	48	0	0	1	1
	72	0	0	1	0
	168	0	0	0	0
	Mean 24-72 h	0	0	1	0.66
3	1	0	0	2	2
	24	0	0	1	1
	48	0	0	1	1
	72	0	0	1	0
	168	0	0	0	0
	Mean 24-72 h	0	0	1	0.66

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Although slight, reversible irritation was observed, the test substance has not to be classified according to DSD and CLP.