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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:
The study was performed between 23 March 2010 and 26 March 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed to GLP and internationally accepted guideline

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 431 (In vitro skin corrosion: Human skin model test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Kieselguhr, soda ash flux-calcined
EC Number:
272-489-0
EC Name:
Kieselguhr, soda ash flux-calcined
Cas Number:
68855-54-9
Molecular formula:
SiO2
IUPAC Name:
Kieselguhr, soda ash flux-calcined
Details on test material:
- Name of test material (as cited in study report): Soda-ash flux calcined kieselguhr
- Physical state: Solid
- Purity: 100%
- Lot/batch No.: 211184
- Expiration date of the lot/batch: 31 December 2013
- Storage condition of test material: Room temperature in the dark

Test animals

Species:
other: EPISKIIN™ Reconstituted Human Epidermis model

Test system

Amount / concentration applied:
TEST MATERIAL
- Amount applied: 20 mg


VEHICLE
Test material was used as suppled
Duration of treatment / exposure:
Duplicate tissues were treated with the test material for exposure periods of 3, 60 and 240 minutes.

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other: other: Relative mean viability %
Value:
102.8
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 3 minutes. (migrated information)
Irritation / corrosion parameter:
other: other: Relative mean viability %
Value:
111.3
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 60 minutes. (migrated information)
Irritation / corrosion parameter:
other: other: Relative tissue viability %
Value:
114.1
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 240 minutes. (migrated information)

Any other information on results incl. tables

Direct MTT reduction

The MTT solution containing the test material did not turn blue/purple. This was taken to indicate the test material did not reduce MTT

Table 1: Mean OD540 values and viabilities for the negative control, positive control material and test material

Material

Exposure period

Mean OD540of duplicate tissues

Relative mean % viability

Negative control material

240 minutes

0.142

100*

Positive control material

240 minutes

0.013

9.2

Test material

240 minutes

0.162

114.1

60 minutes

0.158

111.3

3 minutes

0.146

102.8

* = The mean viability of the negative control tissues is set at 100%

Table 2: Qualitative evaluation of tissue viability (MTT uptake visual evaluation)

Material

Exposure period

Tissue 1

Tissue 2

Negative control material

240 minutes

-

-

Positive control material

240 minutes

++

++

Test material

240 minutes

-

-

60 minutes

-

-

3 minutes

-

-

- = Blue tissue (viable)

++ = Tissue completely white (dead)

The relative mean tissue viability for the positive control treated tissues was 9.2% relative to the negative control treated tissues following the 240 -minute exposure period. The positive control acceptance criterion was therefore satisfied.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was considered to be non-corrosive to the skin