Formaldehyde, reaction products with m-phenylenediamine, sodium sulfide (Na2S) and sulfur

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14-Aug-2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Formaldehyde, reaction products with m-phenylenediamine, sodium sulfide (Na2S) and sulfur

EC Number:

274-986-8

EC Name:

Formaldehyde, reaction products with m-phenylenediamine, sodium sulfide (Na2S) and sulfur

Cas Number:

70892-34-1

Molecular formula:

not applicable

IUPAC Name:

Formaldehyde, reaction products with m-phenylenediamine, sodium sulfide (Na2S) and sulfur

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Details on test material:

- Name of test material (as cited in study report): C.I. Leuco Sulphur Brown 37
- Substance type: Dark brown paste
- Physical state: Solid
- Storage condition of test material: At room temperature in the dark

Test animals / tissue source

Species:

cattle

Test system

Amount / concentration applied:

TEST MATERIAL
- Amount applied: Due to the consistency of the test substance, dark brown paste, the test substance was applied directly on the corneas with a cotton swab in such a way that the cornea was completely covered

NEGATIVE CONTROL
- Amount applied: 750 µL of physiological saline per cornea

POSITIVE CONTROL
Amount applied: 750 µL per cornea
Concentration: 10% (w/v) Benzalkonium Chloride

Duration of treatment / exposure:

- Exposure: 10 minutes
- Post incubation period: 120 minutes

Details on study design:

TEST SITE
- Isolated bovine cornea

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 10 minutes

SCORING SYSTEM:
- After the 10 minutes exposure and washing step, the corneas were incubated for 120 +/- 10 minutes at 32 °C. After the completion of the incubation period opacity determination was performed.

- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:

In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).

TOOL USED TO ASSESS SCORE:
- opacitymeter and microplate reader

DATA EVALUATION:
A test substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Remarks:

time point: 10 minutes

Value:

0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

C.I. Leuco Sulphur Brown 37 is not irritant or corrosive in the Bovine Corneal Opacity and Permeability test.

Executive summary:

The the test item was tested for its potential eye irritation properties in a Bovine Corneal Opacity and Permeability (BCOP) test according to OECD 437.

The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas, except the response of one cornea. However since the opacity and permeability value were just above the upper limit of the range and all other values were less than the upper limits of the laboratory historical range, this deviation in the opacity and the premeability score had no effect on the results of the study.

 

The mean in vitro irritancy score of the positive control (10% (w/v) Benzalkonium Chloride) was 117 and was within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

 

C.I. Leuco Sulphur Brown 37 did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 0 after 10 minutes of treatment.