3-aminobenzenesulphonic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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: see 'Remark'

Remarks:

According to: OECD Guideline for the testing of Chemicals 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method (Original Guideline adopted July 22, 2010), and as described in detail in the Protocol for: In Vitro EpiDermTM Skin Irritation Test (EPI-200-SIT) for use with MatTek Corporation’s Reconstructed Human Epidermal Model EpiDerm (EPI-200), Rev. 1/19/2010

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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

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:

Approximately 25 mg of the neat test item were applied to each three EpiDerm (MatTek) tissues. Additionally, the tissues were wetted with 40 µL of DPBS.

Duration of treatment / exposure:

The skin equivalents were exposed to the test item for 60 minutes. After completion of of the treatment the test item was rinsed off and the skin equivalents were incubated for further 42 hours.

Details on study design:

Approximately 25 mg of the neat test item and 30 µL of the negative control (DPBS) or the positive control (5% SLS) were applied to each three EpiDerm (MatTek) tissues. Additionally, the test item treated tissues were wetted with 40 µL of DPBS. The test item as well the controls were rinsed off the tissues after 60 minutes treatment. After further 42 hours incubation the tissues were treated with the MTT solution for 3 hours following approximately 69 hours ectraction of the colorant from the cells. The amount of extracted colorant was determeined photometrically at a wavelength of 570 nm.

Results and discussion

In vivo

Irritant / corrosive response data:

Compared to the relative absorbance value of the negative control the mean relative absorbance value decreased to 93.8% after exposure of the test item Metanilsäure to the skin tissues. This value is well above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential.

Any other information on results incl. tables

Results after treatment with Metanilsäure and the controls

 

Dose Group	Treatment Interval	Absorbance 570 nm Tissue 1*	Absorbance 570 nm Tissue 2*	Absorbance 570 nm Tissue 3*	Mean Absorbance of 3 Tissues	Standard Deviation	Mean Rel. Absorbance [% of Negative Control]**
Negative Control	60 min	1.729	1.643	1.658	1.677	2.8	100.0
Positive Control	60 min	0.043	0.045	0.044	0.044	0.0	2.6
Test Item	60 min	1.592	1.603	1.522	1.572	2.6	93.8

 

*       Mean of three replicate wells after blank correction
**      relative absorbance [rounded values]:

Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent did not show blue colour.

The mean relative absorbance value of the test item, corresponding to the cell viability, decreased to 93.6% (threshold for irritancy:≤50%), consequently the test item was not irritant to skin.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Metanilsäure is not irritant to skin.

Executive summary:

This in vitro study was performed to assess the irritation potential of Metanilsäure by means of the Human Skin Model Test.

Three tissues of the human skin model EpiDerm^™were treated with the test item, the negative or the positive control for 60 minutes.

Approximately 25 mg of the test item were applied to each tissue, wetted with 40 µL DPBS, and spread to match the tissue size.

30 µL of either the negative control (DPBS) or the positive control (5% Sodium lauryl sulfate) were applied to each tissue.

The test item and the positive and negative controls were washed off the skin tissues after 60 minutes treatment. After further incubation for about 41.5 hours the tissues were treated with the MTT solution for 3 hours following about 69 hours extraction of the colorant from the cells. The amount of extracted colorant was determined photometricallyat 570 nm.

After treatment with the negative control the absorbance values were well above the required acceptability criterion of mean OD greater or equal than 1.0 and less or equal than 2.5 for the 60 minutes treatment interval thus showing the quality of the tissues.

Treatment with the positive control induced a decrease in the relative absorbance as compared to the negative control to 2.6% thus ensuring the validity of the test system.

The standard deviations between the % variabilities of the test item, the positive and negative controls were below 3% (threshold of the "OECD Guideline for the Testing of Chemicals 439: In vitro Skin Irritation: Reconstructed Human Epidermis Test Method”: 18%), thus ensuring the validity of the study.

Compared to the relative absorbance value of the negative controlthe mean relative absorbance value decreased to 93.8% after exposure of the test item Metanilsäure to the skin tissues. This value is well above the threshold for irritancy of less or equal 50%. Therefore, the test item is not considered to possess an irritant potential.