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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:
Start date:16 February 2009; end date: 20 February 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed according to OECD and 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 guideline
Qualifier:
according to
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
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): Custom Red #2
- Substance type:
- Physical state: Violet powder
- Lot/batch No.: C50APR0805D
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark

Test animals

Species:
other: EpiDerm Skin Model

Test system

Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg, moistened with 25 μl of Milli-Q water
Duration of treatment / exposure:
3 minutes and 1 hour exposure on human skin model
Details on study design:
TEST SITE
- Area of exposure: human skin model
- % coverage: 0.6 cm2
- Type of wrap if used:


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


SCORING SYSTEM: % viability of the cells

Results and discussion

In vivo

Results
Irritation parameter:
other: percentage viability
Basis:
other: 2 tissues per exposure time
Time point:
other: 3 minutes and 1 hour
Score:
ca. 83 - ca. 90

Any other information on results incl. tables

 Mean tissue viability in thein vitro skin corrosion test with Custom Red #2

 

 

3-minute application

viability (percentage of control)

1-hour application

viability (percentage of control)

Negative control

100

100

Custom Red #2

83

90

Positive control

7

7

 

 

Applicant's summary and conclusion

Interpretation of results:
other: Not corrosive
Remarks:
Criteria used for interpretation of results: other: OECD guideline 431
Conclusions:
Custom Red #2 is not corrosive in the in vitro skin corrosion study.