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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vitro
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:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Biomass residue (liquid) obtained after B2 production
IUPAC Name:
Biomass residue (liquid) obtained after B2 production

Test system

Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl


POSITIVE CONTROL
- 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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: percentage viability
Basis:
other: percentage of control
Time point:
other: 3 minutes
Score:
93
Time point:
other: 1 hour
Score:
92

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 3-minute and 1-hour treatments with Biomass residue (liquid) obtained after B2 production compared to the negative control tissues was 93% and 92%, respectively. Because the mean relative tissue viability for Biomass residue (liquid) obtained after B2 production was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment Biomass residue (liquid) obtained after B2 production 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 Biomass residue (liquid) obtained after B2 production is not corrosive in the in vitro skin corrosion test.

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