3-aminobenzenesulphonic acid

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:

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:

2012

Report date:

2012

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

3-aminobenzenesulphonic acid

EC Number:

204-473-6

EC Name:

3-aminobenzenesulphonic acid

Cas Number:

121-47-1

Molecular formula:

C6H7NO3S

IUPAC Name:

3-aminobenzene-1-sulfonic acid

Details on test material:

Identity: Metanilsäure
Other Name: 3-Aminobenzenesulfonic acid (EINECS)
CAS-No.: 121-47-1

Test system

Amount / concentration applied:

A 20% (w/v) suspension of the test item in physiological saline was prepared. Each 0.75 mL of the suspension were applied to three bovine corneas.

Duration of treatment / exposure:

The corneas were exposed to the test item suspension for 240 minutes.

Details on study design:

Three bovine corneas were exposed to each 0.75 mL of a 20% (w/v) suspension of the test item in physiological saline for 240 minutes. After treatment the test item suspension was rinsed off the corneas and the corneas' opacity was determined. In a second step the permeability of the corneas was determined photometrically after 90 minutes treatment with fluorescein solution.

Results and discussion

In vivo

Irritant / corrosive response data:

Relative to the negative control, the test item Metanilsäure did not cause any increase of the corneal permeability. Slight opacity effects could be observed. The calculated mean in vitro irritation score of 19.83 was below the threshold of ≥ 55.1. Therefore the test item is classified as not corrosive / not severe irritant to the eye according to OECD 437.

Any other information on results incl. tables

Results after 240 Minutes Incubation Time

Test Group	Opacity value = Difference (t240-t0) of Opacity		Permeability at 490 nm (OD490)		In vitro Score	Mean in vitro irritation score	Proposedin vitro Irritation Scale
		Mean		Mean
Negative Control	0	- 0.33	0.074	0.065	1.11	0.64	Non corrosive / not severe irritant
	0		0.063		0.95
	- 1		0.058		- 0.13
Positive Control	229.33*		0.073*		230.43	214.08	Corrosive / severe irritant
	195.33*		0.019*		195.62
	215.33*		0.057*		216.19
Metanil-säure	20.33*		- 0.014*		20.12	19.83	Non corrosive / not severe irritant
	16.33*		- 0.017*		16.08
	23.33*		- 0.003*		23.29

*corrected values

Applicant's summary and conclusion

Interpretation of results:

other: not corrosive

Remarks:

Criteria used for interpretation of results: OECD GHS

Conclusions:

In conclusion, according to the current study and under the experimental conditions reported, the test item Metanilsäure is not corrosive / not severely irritating to the eye (CLP/EPA/GHS (Cat 1)).

Executive summary:

This in vitro study was performed to assess the corneal irritation and damage potential of Metanilsäure by means of the BCOP assay using fresh bovine corneas.

Prior to the application, opacity of the fresh bovine corneas was measured (t₀), and 600 mg of the test item were suspended in 3.0 mL saline (20% (w/v)). The positive control was 10% (w/v) Benzalkonium chloride in saline. Saline was used as negative control item.

The exposed corneas were incubated for 240 minutes at 32 ± 1 °C in complete medium. After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneas and opacity was measured again (t₂₄₀).

After the opacity measurements permeability of the corneas 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 (mean in vitro irritation score 0.64).

The positive control (10% (w/v) Benzalkonium chloride in saline) showed clear opacity effects (mean in vitro irritation score 214.08) corresponding to a classification as corrosive /severe irritant to the eye (CLP/EPA/GHS (Cat 1)).

Relative to the negative control, the test item Metanilsäure did not cause any increase of the corneal permeability, and only slight opacity occurred. The calculated mean in vitro irritation score of 19.83 was below the threshold of ≥ 55.1. Therefore the test item is classified as not corrosive / not severe irritant to the eye according to OECD 437.