Sulphanilic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

other: in vitro

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according to OECD test guideline draft (Draft Proposal for a New Guideline, In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method, Version 7.6, 9 September 2009) under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD Guideline for the Testing of Chemicals, Draft Proposal for a New Guideline, In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method, Version 7.6, 09.09.09

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Sulphanilic acid

EC Number:

204-482-5

EC Name:

Sulphanilic acid

Cas Number:

121-57-3

Molecular formula:

C6H7NO3S

IUPAC Name:

4-aminobenzene-1-sulfonic acid

Details on test material:

- Name of test material (as cited in study report):SULFANILIC ACID TECHNICAL GRADE
- Molecular formula (if other than submission substance): H2N-C6H4-SO3H
- Molecular weight (if other than submission substance): 173.19 g/mol
- Physical state: LIGHT GREY POWDER SLIGHTLY BLUISH
- Analytical purity: 99,12%
- Lot/batch No.: M001/09
- Expiration date of the lot/batch: Oct. 2011
- Storage condition of test material: Room Temperature: (20 ± 5°C); Keep away from humidity

Test animals

Species:

other: human reconstituted skin model (EpiDerm)

Strain:

other: not applicable

Test system

Type of coverage:

open

Preparation of test site:

other: not applicable

Vehicle:

unchanged (no vehicle)

Remarks:

tissues were wetted before application

Controls:

other: not applicable

Amount / concentration applied:

approx. 25 mg

Duration of treatment / exposure:

60 min.

Observation period:

incubation of 24 hours plus subsequent 18 ± 2 hours for post-incubation period

Number of animals:

not applicable

Details on study design:

- three tissues were treated with the substance
- negative and positive controls (Sodium dodecylsulphate, CAS No. 151-21-3, solution in deionised H2O containing 5%) were run in parallel

Results and discussion

In vivo

Results

Irritation parameter:

other: cell viability

Basis:

other: MTT reduction / formazan formation

Time point:

other: 42 hours

Score:

101.5

Reversibility:

other: not applicable

Remarks on result:

other: score is % cell viability

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a study according to OECD Guideline for the Testing of Chemicals, Draft Proposal for a New Guideline, In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method (Version 7.6, 9 September 2009) under GLP, the test substance did not show any skin irritation potential and is therefore consider as not skin irritating.

Executive summary:

Three tissues of the human skin model EpiDerm^TMwere treated with the test substance for 60 minutes.

25 mg of the solid test item were applied to each tissue (wetted with 25 µL DPBS-buffer) and spread to match the tissue size.

DPBS-buffer was used as negative control, 5% SDS-solution was used as positive control.

After treatment with the negative control, the absorbance values were within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control showed clear irritating effects. Variation within tissues was acceptable (< 18%).

After the treatment with the test item, the relative absorbance values were 101.5 %. This value is well above the threshold for irritation potential (50%). Therefore, the test substance is considered as not skin irritating.