Carbon disulphide

Eye irritation

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

Test material information

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.