Carbazamidine sulphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

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 i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

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)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Guanidinium phosphate (1:1)

EC Number:

226-551-9

EC Name:

Guanidinium phosphate (1:1)

Cas Number:

5423-22-3

Molecular formula:

CH5N3.H3O4P

IUPAC Name:

Guanidium phosphate (1:1)

Test system

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: approx. 750ul per cornea (20% (w/w) test substance)

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

POSITIVE CONTROL
- Amount applied: 750 µl per cornea (20% (w/v) Imidazole)

Duration of treatment / exposure:

240 minutes

Details on study design:

TEST SITE
- Isolated bovine cornea

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 240 minutes

SCORING SYSTEM:
- After exposure the cornea is thoroughly rinsed to remove the test substance followed by immediate opacity measurement and permeability evaluation of the cornea.

- 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

Run / experiment:

mean

Value:

4

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

The individual in vitro irritancy scores for the negative controls ranged from -1.1 to 1.1. The individual positive control in vitro irritancy scores ranged from 92 to 112.
The corneas treated with Guanidine phosphate (1:1) showed opacity values ranging from 3 to 6 and permeability values ranging from -0.008 to 0.009. The corneas were clear after the 240 minutes of treatment with Guanidine phosphate (1:1). A pH effect of the test substance was observed on the rinsing medium, the corneas were rinsed until no colour change of the medium was observed. Hence, the in vitro irritancy scores ranged from 2.9 to 6.1 after 240 minutes of treatment with Guanidine phosphate (1:1).
The corneas treated with the positive control were turbid after the 240 minutes of treatment.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Guanidinium phophate (1:1) is not irritant or corrosive in the Bovine Corneal Opacity and Permeability test.

Executive summary:

The eye irritancy potential of guanidine phosphate (1:1) was assessed using the Bovine Corneal Opacity and Permeability test (BCOP test). The negative and positive control responses of the opacity and permeability values were within the range of the laboratory historical range indicating that the test system functioned properly (positive control: 103; negative control: 0).

Guanidine phosphate (1:1) did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 4.0 after 240 minutes of treatment. Based on these data, it can be concluded that guanidine phosphate (1:1) is not severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.