Registration Dossier

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:
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. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 EpiDermTMwere 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.