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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:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to: OECD Guideline for Testing of Chemicals 437: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants (September, 2009).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD Guideline for Testing of Chemicals 437: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants (September, 2009).
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
carbon disulfide
IUPAC Name:
carbon disulfide
Details on test material:
Identity: Carbon disulfide (provided by AkzoNobel)
Batch-No.: 0600809041160
CAS-No.: 75-15-0
EC-No.: 200-843-6
Purity: > 99%
Stability in Solvent: Not relevant
Storage: At room temperature, under Nitrogen, avoid vapour release and contact of vapour with open flame and/or hot surfaces
Expiration Date: September 19, 2011

Test system

Amount / concentration applied:
0.75 mL of the undiluted liquid test item were applied to the isolated corneas
Duration of treatment / exposure:
The corneas were exposed to the test item for 10 minutes
Details on study design:
Corneas were treated with the undiluted test item for 10 minutes. After treatment the test item was washed off the corneas and they were further incubated for 2 hours. The opacity of the corneas was determined after the two hours incubation. The change in permeability of the corneas was determined after 90 minutes treatment with fluorescein solution.

Results and discussion

In vitro

Results
Irritation parameter:
cornea opacity score
Value:
0.37
Remarks on result:
other: see below for details
Other effects / acceptance of results:
The test item Carbon disulfide did not cause any opacity or permeability of the corneae compared with the results of the negative control. The calculated mean in vitro score was 0.37 and therefore, the test item was classified as non eye irritant.

Any other information on results incl. tables

Results after 10 Minutes Incubation Time


Test Group

Opacity value = Difference (t130-t0) of Opacity

Permeability at 490 nm (OD490)*

In vitro score

Mean in vitro score

Proposed in vitro irritation Scale

 

 

Mean

 

Mean

 

 

 

Negative Control

- 1

- 0.33

0.049

0.047

- 0.27

0.38

Non eye irritant

0

0.047

0.71

0

0.046

0.69

Positive Control

58.33*

0.856*

71.17

77.34

Severe eye irritant

66.33*

0.885*

79.60

69.33*

0.794*

81.24

Carbon disulfide

0.33*

0.008*

0.45

0.37

Non eye irritant

0.33*

0.001*

0.34

0.33*

- 0.001*

0.31

*corrected values

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Carbon disulfide is not considered to be an eye irritant.
Executive summary:

This in vitro study was performed to assess the corneal irritation and damage potential of carbon disulfide by means of the BCOP assay using fresh bovine corneas. After a first opacity measurement of the fresh bovine corneae (t0), carbon disulfide, the positive, and the negative controls were applied to corneas and incubated for 10 minutes at 32±2 °C in complete medium. After the incubation phase the test item, the positive, and the negative controls were each rinsed off the corneas and opacity was measured again (t10). Further, the corneas were incubated for another 120 minutes at 32±2 °C in complete medium, and opacity was measured a third time (t130). After the opacity measurements permeability of the corneas was determined while application of 1 mL of a fluorescein solution for 90 minutes at 32±2 °C in a horizontal position. The liquid coming out was measured spectrophotometrically.

With the negative control (0.9% NaCl solution) neither an increase of opacity nor permeability of the corneae could be observed. The mean in vitro score was calculated as 0.38. The positive control (2-Ethoxyethanol) showed clear opacity and distinctive permeability of the corneae and therefore, is classified as severe eye irritant. The mean in vitro score was calculated as 77.34. The test item carbon disulfide did not cause any opacity or permeability of the corneae compared with the results of the negative control. The calculated mean in vitro score was 0.37 and therefore, the test item was classified as non eye irritant.