Potassium acetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1990-07-02 to 1990-09-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according to OECD guideline, with GLP compliance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Potassium acetate

EC Number:

204-822-2

EC Name:

Potassium acetate

Cas Number:

127-08-2

Molecular formula:

C2H4O2.K

IUPAC Name:

potassium acetate

Details on test material:

- Name of test material (as cited in study report): Safeway KA, LP 1848 (50 % water solution of Potassium acetate)
- Molecular formula (if other than submission substance): CH3COO-K+
- Molecular weight (if other than submission substance): 1,28 kg/L
- Analytical purity: 50,1% Potassium acetate
- Impurities (identity and concentrations): 0,10% Tolyltriazol; 0,05% H3PO4; rest water till 100%.
- Purity test date: 1990-07-16
- Lot/batch No.: Hoe CG 0255 OA ZD50 0001
- Storage condition of test material: 20 ºC (in dark)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG,
- Age at study initiation: 3-5 months
- Weight at study initiation: 3.4 - 4.1 kg
- Diet (e.g. ad libitum): Altromin 2123 (ca. 15 g/day)
- Water (e.g. ad libitum): deionized chlorinated water from automatic watering, ad libitum
- Housing:in fully air-condition, spaces in single cages

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 ºC
- Humidity (%): 50 +/- 20%
- Photoperiod (hrs dark / hrs light): 12 hours

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of test substance Safeway KA

Duration of treatment / exposure:

Duration: 24 hours.

Observation period (in vivo):

Observation period: 1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

Three animals were used.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with physiologic NaCl
- Time after start of exposure: after 24 hours.

SCORING SYSTEM:
CORNEA:
Opacity: degree of turbidity (for the evaluation is the densest place genom):
0. No ulceration or opacity
1. Scattered or diffuse opacity (other than slight turbidity ofnormal luster), details of iris clearly visible
2. Easily discernible translucent area, details of iris slightly shadowed
3. Pearly areas, no details of iris visible, size of pupil barely discernible
4. Opaque cornea, iris not discernible due to the opacity

IRIS:
0.Normal
1.Extremely depth wrinkles, congestion, swelling, slight circum-corneal hyperemia or injection, any of these symptoms, or a combina tion of the various symptoms, the iris still reacts to light (sluggish reaction is positive).
2.No reaction to light, haemorrhage, severe damage (one or all symptoms)

CONJUNCTIVAE
Redness, lids and / or nictitating
0. Blood vessels normal,
1. Some blood vessels show a marked hyperemia (injection)
2. Diffuse crimson color, individual vessels not easily discernible
3. Diffuse bright

Chemosis: lids and / or nictitating
0. No swelling
1. Any swelling above normal lying (including haw)
2. Obvious swelling with partial eversion of lids
3. Swelling with lids about half closed
4. Swelling with more than half-closed lids

TOOL USED TO ASSESS SCORE: fluorescein NaCl (0.01%) examined in UV light.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 72h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 72h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 72h

Score:

1

Max. score:

3

Any other information on results incl. tables

Based on the present study assessed Potassium acetate is therefore not considered to be irritating.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the present study assessed Potassium acetate is therefore not considered to be irritating.

Executive summary:

An eye irritation test (72 hours) using 3 rabbits has been performed on the test substance LP 1848 (50 % water solution of Potassium acetate) in accordance with guideline OECD Guideline 405 (Acute Eye Irritation / Corrosion).

Based on the present study assessed Potassium acetate is therefore not considered to be irritating.

In this test, the control parameters were within the recommended ranges based.