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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication. Purity of the test material unknown.

Data source

Reference
Reference Type:
publication
Title:
Development and Interlaboratory Evaluation of an in Vitro Human Cell-Based Test to Aid Ocular Irritancy Assessments
Author:
Osborne R, Perkins MA and Roberts DA
Year:
1995
Bibliographic source:
Fundamental and Applied Toxicology 28: 139-153

Materials and methods

Principles of method if other than guideline:
A human cell-based in vitro method was developed to screen for ocular irritancy potential of aqueous compatible and incompatible test agents, such as liquids, insoluble solids, powders, granulars, emulsions, and acids/alkalis.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium dihydroxide
EC Number:
215-137-3
EC Name:
Calcium dihydroxide
Cas Number:
1305-62-0
Molecular formula:
CaH2O2
IUPAC Name:
calcium dihydroxide
Details on test material:
- Name of test material (as cited in study report): Calcium hydroxide powder
- Analytical purity: no data given

Test system

Vehicle:
not specified
Amount / concentration applied:
The substances were tested at the same concentration (undiluted) tested previously in vivo.
Duration of treatment / exposure:
up to 30 min
Details on study design:
Cell cultures used in this work were cocultured human foreskin-derived dermal fibroblasts and epidermal keratinocytes, grown on a nylon mesh substrate. The final cultures were noncornified stratified squamous epithelium and resemble the outermost stroma and epithelium of the cornea.

The hypothesis tested and confirmed in this work was that the rate of cytotoxicity induced by topical application of the test material to the stratified epithelial cell cultures would correlate with ocular irritancy.

The test materials were applied to the cell system for up to 30 min., and cytotoxicity was measured as decreased 3-[4,5-dimethylthiazol-2-yl]2,5-diphenyltetrazolium bromide (MTT) vital dye metabolism. The time (in minutes) of exposure to test agent that reduced MTT metabolism to 50 % of control levels (the t50 value) was calculated.
These values were compared to historic rabbit low-volume eye test maximum average scores (LVET MAS).

Results and discussion

In vivo

Results
Irritation parameter:
other: irritation
Basis:
other: not applicable
Time point:
other: not applicable
Score:
> 0
Reversibility:
other: not applicable
Remarks on result:
other: The potential of the test substance to cause serious damage to the eye is evident.
Irritant / corrosive response data:
The test material calcium hydroxide was a highly irritating substance and damaged the cultures very rapidly. The t50 value was 0.29 +/- 0.01 min (n=2). This result was in good correlation with the results obtained in an in-vivo LVET-MAS (46.3 +/- 1.7), (n=3).
For comparison, a non-irritating material which was also tested in this study (a skin care product), had a t50 value of >30 min and a LVET-MAS of 0.0 +/- 0.0.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information