TRACER YELLOW D-100

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to OECD guideline 437 and EC test method B47

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

GLP compliance:

yes (incl. QA statement)

Remarks:

Harlan Cytotest cell research GmbH

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

orange solid powder

Test animals / tissue source

Details on test animals or tissues and environmental conditions:

isolated bovine cornea according to OECD guideline 437

Test system

Amount / concentration applied:

0.75 mL

Duration of treatment / exposure:

240 minutes

Results and discussion

In vivo

Results

Irritation parameter:

other: In vitro score

Basis:

mean

Time point:

other: 240

Score:

< 55.1

Max. score:

0.19

Reversibility:

not specified

Irritant / corrosive response data:

Not corrosive / not severe irritant to the eye

Any other information on results incl. tables

Table of results.

Results after 240 minutes incubation time.

*corrected values

**negative values are only calculated values that do not reflect reality

Test group	opacity value = difference (t240 -t0 ) of opacity	Mean	permeability at 490 nm (OD490)	Mean	in vitro score	mean in vitro irritation score	proposed in vitro irritation scale
Negative control	231	2.00	0.0630.0560.055	0.058	2.953.841.83	2.87	Non corrosive / non severe irritant
Positive control	192.00*172.00*185.00*		0.046*0.036*0.017*		192.69172.54185.26	183.50	Corrosive / severe irritant
D-100	-1.00*-2.00*-2.00*		0.079*0.002*-0.002*		0.19-1.97-2.03	0.00 (-1.27**)	Non corrosive / non severe irritant

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Not corrosive / not severe irritant to the eye

Executive summary:

This in vitro study was performed to assess the corneal irritation and damage potential of D- 100 by means of the BCOP assay using fresh bovine corneae. After a first opacity measurement of the fresh bovine corneae (t0), the 20% (w/v) suspension in saline (0.9% (w/v) NaCl in deionised water) of the test item D-100, the positive, and the negative controls were applied to corneae and incubated for 240 minutes at 32 ± 1 °C. The posterior chamber contained MEM medium supplemented with sodium bicarbonate and Lglutamine and 1% fetal calf serum (FCS) (complete medium = cMEM). After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneae and opacity was measured again (t240). After the opacity measurements permeability of the corneae was determined by measuring spectrophotometrically the transfer of sodium fluorescein after incubation in a horizontal position for 90 minutes at 32 ± 1 °C. With the negative control (saline) neither an increase of opacity nor permeability of the corneae could be observed. The positive control (10% (w/v) Benzalkonium chloride in saline) showed clear opacity effects corresponding to a classification as corrosive / severe irritant to the eye (CLP/EPA/GHS (Cat 1)). Relative to the negative control, the test item D-100 did not cause any increase of the corneal opacity or permeability. The calculated mean in vitro irritation score was 0.00. According to OECD 437 the test item is classified as not corrosive / not severe irritant to the eye. In conclusion, according to the current study and under the experimental conditions reported, the test item D-100 is not corrosive / not severe irritant to the eye (CLP/EPA/GHS (Cat 1)).