Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP- and guideline compliant

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 431 Commission Regulation (EC) No 440/2008 OECD Draft for irritation test
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): ASA
- Substance type: organic
- Physical state: Yellowish clear liquid
- Analytical purity: 97.1%
- Lot/batch No.: 5500001727
- Stability under test conditions: stable
- Storage condition of test material: RT

Test system

Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL (corrosion test), 30 µL (irritation test)
- Concentration (if solution): 100%
Duration of treatment / exposure:
1 hour
Observation period:
2 days
Number of animals:
not applicable

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other: other: Absorbance (570 nm)
Value:
1.496
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 42 h. Max. score: 1.6027. Reversibility: no data. Remarks: corrosion test. (migrated information)
Irritation / corrosion parameter:
other: other: Absorbance (570 nm)
Value:
1.788
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 42 h. Max. score: 1.898. Reversibility: no data. Remarks: irritation test. (migrated information)

Any other information on results incl. tables

1. Corrosion test

               Exposure: 3 min           Exposure: 1 hour
 Test article       tissue 1    tissue 2  KC  mean
 NC   mean OD570  1.7627  1.7522  0.2267  1.7574  1.7657  1.6962  0.1762  1.7309
   viability[% of NC]  100.3  99.7  -  100  102.0  98.0  -  100
 ASA   mean OD570  1.8112  1.7222  0.2012  1.7667  1.3892  1.6027  0.1867  1.4959
   viability[% of NC]  103.1  98.0  -  101  80.3  92.6  -  86
 PC   mean OD570  0.4438  0.3498  -  0.3968 0.1597    0.1867  -  0.1732
   viability[% of NC]  25.3  19.9  -  23  9.2  10.8  -  10

Due to the ability of the test substance to reduce MTT directly, a KC was applied in parallel.

However, the result of the KC did not indicate an increased MTT reduction (difference to KC

of NC is not greater than 0.1; see section 3.6.4). Thus the KC was not used for viability

calculation.

2. Irritation test

 Test article    tissue 1  tissue 2  tissue 3  mean  SD
 NC   mean OD570  1.6795  1.6125  1.5725  1.6215  
    viability[% of NC]  103.6  99.4  97.0  100  3.33
 ASA  mean OD570  1.7575  1.7070  1.8980  1.7875  
     viability[% of NC]  108.4  105.3  117.1  110  6.10
 PC   mean OD570  0.1165  0.1320 0.1215   0.1233  
    viability[% of NC]  7.2  8.1  7.5  8  0.49

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the observed results and applying the evaluation criteria it is concluded, that substance does not show a skin irritation potential in the EpiDer ™ skin corrosion/irritation test under the test conditions chosen.