Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 February 2010 to 23 April 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions

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 431 Guideline (In vitro skin corrosion: Human skin model test
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of barium chromate, copper dichromium tetraoxide and copper oxide
EC Number:
701-287-1
Molecular formula:
CuO, CuCr2O4, BaCrO4
IUPAC Name:
Reaction mass of barium chromate, copper dichromium tetraoxide and copper oxide
Details on test material:
- Name of test material (as cited in study report): Chromite de cuivre
- Substance type: multiconstituents
- Physical state: black powder
- Composition of test material, percentage of components: 34% of copper, 8.5% of baryum, 31% of chrome
- Purity test date: 11 January 2010
- Lot/batch No.: 09/0177
- Expiration date of the lot/batch: 17 August 2014
- Storage condition of test material: in darkness at room temperature

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 20 mg of the solid test material was applied topically to the corresponding tissues ensuring uniform coverage of the tissues.
Duration of treatment / exposure:
3, 60 and 240 minutes
Number of animals:
Not applicable

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other: other: cell viability (based on optical density (absorbance) at 540 nm)
Value:
92.4
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 3 minutes. Reversibility: no data. (migrated information)
Irritation / corrosion parameter:
other: other: cell viability (based on optical density (absorbance) at 540 nm)
Value:
80.7
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 60 minutes. Reversibility: no data. (migrated information)
Irritation / corrosion parameter:
other: other: cell viability (based on optical density (absorbance) at 540 nm)
Value:
84.9
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 240 minutes. Reversibility: no data. (migrated information)

Any other information on results incl. tables

Following the 3, 60 and 240 minute exposure periods the test material treated tissues appeared blue which was considered to be indicative of viable tissue. 

The relative mean tissue viability for the positive control treated tissueswas17.6% relative to the negative control treated tissuesfollowing the 240-minute exposure period. The positive control acceptance criterion was therefore satisfied.

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

Material

Exposure Period

Individual OD540

Mean OD540of duplicate tissues

Relative mean % viability

Negative Control Material

240 Minutes

0.116

0.119

(±0.004)

100*

0.121

Positive Control Material

240 Minutes

0.023

0.021
(±0.004)

17.6

0.018

Test Material

240 Minutes

0.099

0.101
(±0.003)

84.9

0.103

60 Minutes

0.091

0.096

(±0.006)

80.7

0.100

3 Minutes

0.112

0.110
(±0.003)

92.4

0.108

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

Applicant's summary and conclusion

Interpretation of results:
other: not corrosive
Conclusions:
The test material was considered to be non-corrosive to the skin and assigned the EU risk phrase of No label, UN packing group Non-corrosive and a CLP risk phrase regulation of Non-corrosive.
Executive summary:

Introduction:

The purpose of this test is to evaluate the corrosivity potential of the test material using the EPISKINTMin vitroReconstituted Human Epidermis (RHE) Model after treatment periods of 3, 60 and 240 minutes. This method was designed to meet the requirements of the following guideline:

- OECD Guideline for the Testing of Chemicals No. 431 “In Vitro Skin Corrosion: Human Skin Model Test” (adopted 13 April 2004)

The EPISKINTMmodel is able to distinguish between corrosive and non-corrosive chemicals for all of the chemical types studied. As stated in regulation 1272/2008/EEC a validatedin vitrotest such asin vitroskin corrosion test in the EPISKINTMmodel can be used for classification and labelling. The EPISKINTMmodel is also able to distinguish between known R35 (UN packing group I) and R34 (UN packing group II & III) chemicals.

Methods:

Duplicate tissues were treated with the test material for exposure periods of 3, 60 and 240 minutes. At the end of the exposure period the test material was rinsed from each tissue before each tissue was taken for MTT-loading. After MTT loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues.

At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 µl samples were transferred to the appropriate wells of a pre-labelled 96-well plate. The optical density was measured at 540 nm.

Data are presented in the form of percentage viability (MTT reduction in the test material treated tissues relative to negative control tissues).

Results:

The relative mean viability of the test material treated tissues was:

3 minutes exposure                        :          92.4%
60 minutes exposure                      :          80.7%
240 minutes exposure                    :          84.9%

Quality criteria:

The quality criteria required for acceptance of results in the test were satisfied.

Conclusion:

The test material was considered to be Non-Corrosive to the skin and assigned the EU risk phrase of No label, UN packing group Non-Corrosive and a CLP risk phrase regulation of Non-corrosive.

Categories Display