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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: Published data
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
When Potassium oxide is hydrated is produced Potassium hydroxide. Therefore, the health effects of Potassium hydroxide need to be considered in the assessment of Potassium oxide 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

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:
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

Reference
Name:
Unnamed
Type:
Constituent
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

Resultsopen allclose all
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
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
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% = 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:
other: corrosive
Remarks:
KOH 5% Criteria used for interpretation of results: EU
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: corrosive