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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04 May 2010 - 10 May 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, no restrictions, fully adequate for assessment
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: B46 of Council Regulation (EC) No 761/2009
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Physical state: white powder
- Purity test date: 11 March 2010
- Expiration date of the lot/batch: end of March 2012
- Stability under test conditions: confirmed
- Storage condition of test material: <30°C

Test animals

Species:
other: in vitro using EpiSkin inserts (3-dimensional human skin model, comprising a reconstructed epidermis with a functional stratum corneum, supplied by SkinEthic Laboratories, Nice, France)
Strain:
other: not applicable

Test system

Type of coverage:
other: not applicable
Preparation of test site:
other: not applicable
Vehicle:
unchanged (no vehicle)
Controls:
other: not applicable
Amount / concentration applied:
25 mg
Duration of treatment / exposure:
15 minutes
Observation period:
not applicable
Number of animals:
not applicable

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: viability of tissues
Value:
98.1
Remarks on result:
other:
Remarks:
Time point: 15 min treatment. (migrated information)

Any other information on results incl. tables

Based on the cell viability measurements obtained, the following mean viability measurements for the test article, negative control and positive control were calculated to be: 98.1%, 100% and 7.9% respectively.

 

These results indicate the viability of the epidermal tissue was not reduced to below 50% of the negative control and therefore may be considered to be non-irritant. The positive control showed an appropriate response in the assay system.

 

No other test substance related effects were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was not irritant to the in vitro skin model EpiSkin.
Executive summary:

In order to assess the in vitro skin irritation potential of salicylamide, EpiSkin inserts were treated with the substance, negative control (phosphate buffered saline (PBS)) and positive control (5% v/v sodium dodecyl sulphate (SDS)) for 15 minutes. At the end of the treatment period, the tissues were washed with PBS and cell viability was assessed using the MTT (3-(4, 5-Dimethylthiazol-2-yl) -2, 5-diphenyltetrazolium bromide, also known as Thiazolyl blue) interacting substances assay. The skin irritation potential was classified according to the remaining cell viability obtained after test article treatment.  

The group mean viability for the test article was 98.1%, for the negative control was 100% and for the positive control was 7.9%.

Salicylamide was not irritant to the in vitro skin model EpiSkin.