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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:
04 November 2009 to 09 November 2009
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
Cross-reference
Reason / purpose:
reference to same study

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
EPISKIN(TM) reconstituted human epidermis model.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
other: reconstituted human epidermis
Strain:
other: not applicable
Details on test animals and environmental conditions:
Not applicable as the test was performed in vitro.

Test system

Type of coverage:
other: test material applied directly
Preparation of test site:
other: not applicable
Vehicle:
unchanged (no vehicle)
Controls:
other: not applicable
Amount / concentration applied:
10 µl of the test material was applied to the epidermis surface.
Duration of treatment / exposure:
15 minutes
Observation period:
Not applicable
Number of animals:
The test was conducted In Vitro. Three replicate test tissues were used for the main test.
Details on study design:
TEST SITE
- Area of exposure: Whole of test tissue surface
- % coverage: 100%
- Type of wrap if used: Not applicable


REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, each tissue was removed from the well of the treatment plate using forceps and rinsed using a wash bottle containing Phosphate Buffered Saline Dulbeccos (PBS) with Ca++ and Mg++. Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream of PBS to gently remove any residual test material.
- Time after start of exposure: 15 ± 0.5 minutes.

SCORING SYSTEM: Not applicable

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: relative mean viability of the test material treated tissues
Value:
87.8
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 15 minutes. Remarks: Score is in % terms. (migrated information)

Any other information on results incl. tables

For the test material the relative mean tissue viabilities obtained after the 15 minute treatment followed by the 42 hour post-exposure incubation period were compared to the mean of the negative control treated tissues (n=3). The relative mean viabilities were calculated in the following way:

Classification of irritation potential is based upon relative tissue viability following the 15 minute exposure period followed by the 42 hour post-exposure incubation period according to the following table:

Criteria for in vitro interpretation

Classification

Mean tissue viability is =50%

Irritant (I) R38

Mean tissue viability is >50%

Non-Irritant (NI)


Mean OD540Values and Percentage Viabilities for the Negative Control Material, Positive Control Material and Test Material

Material

OD540of tissues

Mean OD540of triplicate tissues

±SDof OD540

Relative individual tissue viability (%)

Relative mean viability (%)

± SD of % viability

Negative Control Material

0.932

0.879

0.053

106.0

100*

6.0

0.878

99.9

0.826

94.0

Positive Control Material

0.064

0.068

0.030

7.3

7.8

3.4

0.100

11.4

0.041

4.7

Test Material

0.851

0.772

0.088

96.8

87.8

10.0

0.678

77.1

0.788

89.6

 


SD=   Standard deviation

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

The relative mean viability of the test material treated tissues was 87.8% after a 15 minute exposure.

        

The MTT solution containing the test material did not turn blue/purple which indicated that the test material did not directly reduce MTT.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: As specified in the test method.
Conclusions:
The test material was considered to be Non-Irritant.
Executive summary:

The substance has been found to be non-irritating to skin in an in vitro test using the EPISKINTMreconstituted human epidermis model.