Registration Dossier

Administrative data

Endpoint:
skin 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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
Remarks:
Conducted according to guideline in effect at time of study conduct
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: 22.82% solids in water

Test system

Details on study design:
The Skin Irritation Test using the EpiDerm™ Skin Model was used to predict the skin irritation potential of the test substance in the context of classification of skin irritation hazard according to the EU classification system (R38 or No Label). The test substance, positive control (5% Sodium Dodecyl Sulfate), and negative control (Dulbecco’s Phosphate Buffered Saline) were exposed to the EpiDerm™ tissues in triplicate for 60 minutes, with a post-exposure time of 42 hours. Irritation potential was determined by measuring the relative conversion of MTT (3-[4,5 - dimethylthiazol-2-yl] - 2,5 - diphenyltetrazolium bromide) in the test substance-treated tissues after exposure to the test substance for a 60-minute exposure period, followed by a 42-hour post-exposure expression period. Skin irritation potential of the test substance was predicted if the relative viability was less than or equal to 50%.

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
102.4
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other:
Remarks:
The test substance was not determined to directly reduce MTT.

In vivo

Irritant / corrosive response data:
The mean viability of the test substance was 102.4%. The test substance was not determined to directly reduce MTT.

Any other information on results incl. tables

The mean OD570of the negative control, sterile, Dulbecco’s Phosphate Buffered Saline, was 2.193. The mean viability of the positive control, SDS, was 8.5%. The standard deviation calculated from individual percent tissue viabilities of the 3 identically treated replicates was < 18% for the test substance, positive and negative control. Since the mean positive control result was an R38 classification (i.e. viability ≤ 50%) and the mean OD570value of the negative control was greater than 1.000 and less than 2.500, the assay results were considered valid.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
Not a skin irritant.
Executive summary:

The Skin Irritation Test using the EpiDerm™ Skin Model was used to predict the skin irritation potential of the test substance in the context of classification of skin irritation hazard according to the EU classification system (R38 or No Label). The test substance, positive control (5% Sodium Dodecyl Sulfate), and negative control (Dulbecco’s Phosphate Buffered Saline) were exposed to the EpiDerm™ tissues in triplicate for 60 minutes, with a post-exposure time of 42 hours. Irritation potential was determined by measuring the relative conversion of MTT (3-[4,5 - dimethylthiazol-2-yl] - 2,5 - diphenyltetrazolium bromide) in the test substance-treated tissues after exposure to the test substance for a 60-minute exposure period, followed by a 42-hour post-exposure expression period. Skin irritation potential of the test substance was predicted if the relative viability was less than or equal to 50%. The mean viability of the test substance was 102.4%. The test substance was not determined to directly reduce MTT. Based upon the results of this assay, the test substance was not predicted to be a skin irritant.