Potassium hydroxide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: According to the SIDS document for potassium hydroxide (30 January 2002), a Klimisch score of 2 was assigned since study is well documented, meets generally accepted scientific principles and is acceptable for assessment

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Acute Toxicity of Cesium and Rubidium Compounds

Author:

Johnson GT et al

Year:

1975

Bibliographic source:

Toxicol. Appl. Pharmacol., 32, 239-245

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

grading of severity of the eye irritation was performed by a modification of the Draize method (1944)

Principles of method if other than guideline:

grading of severity of the eye irritation was performed by a modification of the Draize method (1944)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Potassium hydroxide

EC Number:

215-181-3

EC Name:

Potassium hydroxide

Cas Number:

1310-58-3

Molecular formula:

HKO

IUPAC Name:

potassium hydroxide

Details on test material:

- Name of test material (as cited in study report): Potassium hydroxide
- Analytical purity: 85%

Test animals / tissue source

Species:

rabbit

Strain:

other: Albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- albino rabbits
- Weight at study initiation: 2-3 kg

Test system

Vehicle:

water

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 0.1, 0.5, 1.0 and 5.0%

Duration of treatment / exposure:

5 min or 24h

Observation period (in vivo):

1, 24, 48 and 72 hr and 7 days
if any injury persisted : 14 and 21 days

Number of animals or in vitro replicates:

10
KOH (5%) : 1 animal (5min)
KOH (1%): 3 animals (24h)
KOH (0.5%): 3 animals (24h)
KOH (0.1%): 3 animals (24h)

Details on study design:

TOOL USED TO ASSESS SCORE: fluorescein
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 300 mL distilled water during 2 min
- Time after start of exposure: 5min or 24h

SCORING SYSTEM: modified Draize method: based upon the presence and the degree of ulceration or opacity of the cornea and iris and erythema, chemosis and ulceration or necrosis of the conjunctival mucosa

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

other: 5 min

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: KOH 5%: extremely irritant and corrosive

Results 2

Irritation parameter:

overall irritation score

Basis:

animal: 2-4

Time point:

other: 5 min

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: KOH 1% : irritant

Results 3

Irritation parameter:

overall irritation score

Basis:

animal: 2-4

Time point:

other: 24h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: KOH 1%: irritant

Irritant / corrosive response data:

KOH 5%/5 min.: extremely irritant and corrosive (1 rabbit)
KOH 1%/5 min.: irritant (3 rabbits);
KOH 1%/24 hr: irritant (3 rabbits);
KOH 0.5%/24 hr: marginal (3 rabbits);
KOH 0.1%/24 hr: negative (3 rabbits).
Result: KOH 5% = highly corrosive

Any other information on results incl. tables

Quantitative details are reported in: Johnson et al (1972) Acute toxicity studies of cesium and rubidium compounds. Nat Inst Occupational Safety Health Tech Rep 74

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information KOH 5%

Conclusions:

KOH 5%/5 min.: extremely irritant and corrosive
KOH 1%/5 min.: irritant
KOH 0.5%/24 hr: marginal
KOH 0.1%/24 hr: no ocular reactions in the eye
Result: highly corrosive