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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-02-12 to 2015-02-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline compliant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Caesium carbonate
EC Number:
208-591-9
EC Name:
Caesium carbonate
Cas Number:
534-17-8
Molecular formula:
CH2O3.2Cs
IUPAC Name:
Cesium carbonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
other: bovine
Details on test animals or tissues and environmental conditions:
Isolated corneas obtained as a by-product from a slaughterhouse were used after examination for defects. They were mounted in corneal holders with endothelial side against the O-ring of the posterior chamber. After treatment with RPMI an opacity measurement was performed using an opacitometer to discarded corneas that have an initial opacity reading above 7 units. Three corneas with opacity readings approximately equivalent to the median opacity were selected as negative-controll. For testing 750 µL of test item or control substance were used (closed-chamber method). After incubation time substances were removed and the epithelium was washed with MEM (RPMI was used for the controll group). The anterior chamber was refilled with complete RPMI and the opacity measurement was performed. In addition optical density at 490 nm was determined using a spectrophometer. Therefore the poserior chamber was refilled with complete RPMI and the anterior chamber with 1 ml of 5 mg/ml sodium fluorescein solution. After the incubation time of 90 min at 32 +- 1°C the optical density was measured. After that the in vitro irritation score (IVIS) was determined with following formula: mean opacity value + (15 x mean permeabiltiy optical densitiy at 490 nm.

Test system

Vehicle:
physiological saline
Amount / concentration applied:
The test item was suspended with physiological saline 0.9% NaCl (see 10.3) to gain a
20% concentration.
Duration of treatment / exposure:
4 hours +- 5 min to measure the opacity.
90min to measure the optical density at 490 nm.

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Run / experiment:
4 h
Value:
183.05
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: mean

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information
Conclusions:
According to the evaluation criteria the test item cesium carbonate is classified into UN GHS Category 1.
Executive summary:

The eye irritancy potential of cesium carbonate was investigated in the bovine corneal opacity and permeability assay.The study followed the procedures indicated by OECD Guideline for the Testing of Chemicals, number 437 “Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage”. Therefore the test item cesium cabonate was suspended with physiological saline 0.9% NaCl to gain a 20% concentration. The mean in vitro irritation score was calculated at 183.05. Therefore the test item was classified into UN GHS Category 1. The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.