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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03-nov-2009 to 06-nov-2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Deviations:
no
Qualifier:
according to
Guideline:
other: OECD Guideline no. 431 (In Vitro Skin Corrosion: Human Skin Model Test)
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): Silicic acid(H2Si2O5), barium salt(1:1), lead-doped
- Substance type: white powder
- Physical state: powder
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark

Test system

Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg, moistened with 25 µl water

NEGATIVE CONTOL:
- Amount(s) applied (volume or weight with unit): 50 µl water

POSITIVE CONTOL:
- Amount(s) applied (volume or weight with unit): 50 µl KOH
- Concentration (if solution): 8N
Duration of treatment / exposure:
3 minutes and 1 hour exposure times
Details on study design:
TEST SITE
- Area of exposure: human skin model
- % coverage: 0.6 cm²

REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: 3 minutes and 1 hour


SCORING SYSTEM: percentage viability


Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other:
Value:
96
Remarks on result:
other:
Remarks:
Basis: other: percentage of control. Time point: 3 minutes. (migrated information)
Irritation / corrosion parameter:
other: time point
Value:
82
Remarks on result:
other:
Remarks:
Time point: 1 hour. (migrated information)

Any other information on results incl. tables

Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with Silicic acid(H2Si2O5), barium salt(1:1), lead-doped compared to the negative control tissues was 96% and 82% respectively. Because the mean relative tissue viability for Silicic acid(H2Si2O5), barium salt(1:1), lead-doped was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment Silicic acid(H2Si2O5), barium salt(1:1), lead-doped is considered to be not corrosive.

Applicant's summary and conclusion

Interpretation of results:
other: not corrosive
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The positive and negative controls were within the historical control data.

Finally, it is concluded that this test is valid and that Silicic acid(H2Si2O5), barium salt(1:1), lead-doped is not corrosive in the in vitro skin corrosion test.