Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP, equivalent or similar to OECD and EU guideline.
Cross-reference
Reason / purpose:
reference to other study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Acute toxicity of cesium and rubidium compounds
Author:
Johnson, G.T.; Lewis, R.T. and Wagner, W.D.
Year:
1975
Bibliographic source:
Toxicology and applied pharmacology 32, 239-245 (1975)
Reference Type:
publication
Title:
Unnamed
Year:
1972

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Qualifier:
equivalent or similar to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: crystalline

Test animals / tissue source

Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.0 to 3.0 kg

Test system

Vehicle:
water
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentrations: 0.1, 0.5 and 5.0 %

VEHICLE
CsOH was dissolved in deionized-distilled water on a weight-to-weight basis prior to administration.
Duration of treatment / exposure:
Single treatment for either 5 min or 24 hr before washing.
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
5 min treatment: 5 animals
24 h treatment: 3 animals
Sex not specified.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Eyes were washed with a gentle, continuous stream of distilled water until a volume of approximately 250 mL was used.
- Time after start of exposure: 5 min or 24 h

SCORING SYSTEM:
Grades were assigned for the presence and/or degree of ulceration or opacity of the cornea and iris for redness (erythema), chemosis and ulceration or necrosis of the conjunctival mucosa according to the method of Draize. The eyes were examined at 1, 24, 48 , and 72 h at 7 days. If any injury persisted, the animals were re-examined at 24 and/or 21 days.

TOOL USED TO ASSESS SCORE:
The eyes were examined with the aid of fluorescein but without the aid of a hand slit-lamp.

Results and discussion

In vivo

Results
Remarks on result:
other: CsOH (5%) is considered extremely irritating and corrosive to the rabbits eye. Due to the severely of the effects no clear scores could be evaluated. 0.5 % CsOH produced no ocular reaction in the eye of rabbits.
Irritant / corrosive response data:
CsOH (5%) is considered extremely irritating and corrosive to the rabbits eye. Due to the severely of the effects no clear scores could be evaluated. Based on the marked response, an attempt was made to determine the concentration that produced no ocular reaction. 0.5 % CsOH produced no ocular reaction in the eye of rabbits.
Other effects:
One animal died in the high dose group (5%).

Applicant's summary and conclusion

Interpretation of results:
Category I
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based in the results obtained cesium hydroxide (5%) is considered extremely irritating and corrosive to the rabbits eye. Based on the marked response, an attempt was made to determine the concentration that produced no ocular reaction. 0.5 % CsOH produced no ocular reaction in the eye of rabbits.
Executive summary:

In a primary eye irritation study, 0.1 mL of cesium hydroxide (0.1, 0.5 and 5.0 %) in water was instilled into the conjunctival sac of the eye of albino rabbits (in total eight animals) for 5 min or 24 hours. Eyes were washed with water after the exposure period. Animals then were observed for 21 days. Irritation was scored by the method of Draize. CsOH (5%) is considered extremely irritating and corrosive to the rabbits eye. Based on the marked response, an attempt was made to determine the concentration that produced no ocular reaction. 0.5 % CsOH produced no ocular reaction in the eye of rabbits.