Calcium disulphamate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

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)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Calcium disulphamate

EC Number:

237-399-8

EC Name:

Calcium disulphamate

Cas Number:

13770-92-8

Molecular formula:

Ca.2H3NO3S

IUPAC Name:

calcium disulfamate

Specific details on test material used for the study:

Content: 90.9 g/100 g
Identiy: Confirmed
Homogeneity: The test substance was homogenous by visual inspection.
Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor and the sponsor holds this responsibility.
pH: ca. 7 (undiluted test substance, moistened with deionized water; determined in th elab prior to start of the GLP study). Ca. 6 (20% aqueous preparation, determined in the lab prior to start of the GLP study).
Physical state/color: Solid/white
Storage conditions: Room temperature

Test animals / tissue source

Species:

cattle

Test system

Vehicle:

water

Controls:

yes, concurrent vehicle

yes, concurrent positive control

Amount / concentration applied:

20% (w/v) suspension in deionized water

Duration of treatment / exposure:

4 h

Details on study design:

The objective of this in vitro test is to assess the potential of the test substance to cause serious eye damage. According to OECD Guideline 437 (adopted July 2013), also substances that do not require classification for eye irritation or serious eye damage can be identified. However, due to insufficient predictivity the latter derivation is not recommended by the test facility.
The test method consists of a topical exposure of the test substance to the epithelial surface of isolated corneas from the eyes of cattle freshly slaughtered. Corneal opacity is quantitatively measured as the amount of light transmitted through the cornea. Permeability is quantitatively measured as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements are used to calculate an In Vitro Irritancy Score (IVIS) of the test substance which is used for the prediction of serious eye damage.

Isolated bovine cornea: The test system is the isolated bovine cornea. Bovine eyes are obtained as a by-product of freshly slaughtered cattle
(age of the animals: minimum 12 months, maximum 60 months).
Supplier: Schlachthof Mannheim, Schlachthofstr. 21, 68165 Mannheim, Germany

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

mean of 3 corneas

Value:

0.1

Vehicle controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

not corrosive to eyes

Executive summary:

The objective was to assess the eye irritating potential of Calcium disulphamate. By using the methods currently available a single in vitro assay is not sufficient to cover the full range of eye irritating potential. Therefore, two in vitro assays were part of this in vitro eye irritation test strategy: The Bovine Corneal Opacity and Permeability Test (BCOP Test) and EpiOcular Eye Irritation Test.

The potential of the test substance to cause ocular irritation or serious damage to the eyes was assessed by a single topical application of 750 μL of a 20% test-substance preparation in deionized water to the epithelial surface of isolated bovine corneas. Three corneas were treated with the test substance preparation for an exposure period of 4 hours.

In addition to the test substance, a negative control (NC; deionized water) and a positive control (PC; 20% imidazole in deionized water) were applied to three corneas each. Corneal opacity was quantitatively measured as the amount of light transmitted through the cornea. Permeability was quantitatively measured as the amount of sodium fluorescein dye

that passes across the full thickness of the cornea. Both measurements were used to calculate an In Vitro Irritancy Score of the test substance. The mean IVIS for the test substance, the negative and the positive control was 0.1, 14.1, and 160.3, respectively. The substance was therefore not identified as corrosive or severe irritant.