Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - guideline study with only minor deviations

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:
yes
Remarks:
no concurrent positive control was conducted
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 431
Deviations:
yes
Remarks:
no concurrent positive control was conducted
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of aluminium and magnesium oxide and spinel (Mg(AlO2)2)
EC Number:
701-289-2
Molecular formula:
Al, MgO, Mg(AlO2)2
IUPAC Name:
Reaction mass of aluminium and magnesium oxide and spinel (Mg(AlO2)2)
Details on test material:
- Name of test material (as cited in study report): Aluminium-Skimmings
- Physical state: grey solid
- Analytical purity: Aluminium: 708.0 g/kg
Ammonium(NH4): 22.0 g/kg
Magnesium: 68.0 g/kg
- Lot/batch No.: Lieferung vom 21.04.2009
- Stability under test conditions: until August 21, 2011
- Storage condition of test material: room temperature

Test animals

Species:
other: not applicable, in-vitro test
Strain:
other: not applicable, in-vitro test

Test system

Type of coverage:
other: not applicable, in-vitro test
Preparation of test site:
other: not applicable, in-vitro test
Vehicle:
physiological saline
Controls:
other: not applicable, in-vitro test
Amount / concentration applied:
The test item was applied at a 100% concentration, i.e. 25 mg per insert. (plus 50 µL 0.9% NaCl to moisten and ensure good contact with the skin)
Duration of treatment / exposure:
3 + 60 min
Observation period:
not applicable
Number of animals:
not applicable, in-vitro test
Details on study design:
The experiment was carried out on a reconstructed human epidermis EST-1000 (CellSystems, St. Katharinen, Germany) for detection of topically applied skin corrosives.
A 100% concentration was tested on the skin/epidermal equivalents in triplets. For the determination of time related cytotoxic effects the incubation periods were 3 min. and 60 min., respectively.
To check the reliability of this test procedure a blinded positive/negative control study is conducted at regular intervals in the lab. This reliability check is always performed by two technicians, two laboratories in parallel using the same batches of the control test items.
The test item was applied at a 100% concentration, i.e. 25 mg per insert. (plus 50 µL 0.9% NaCl to moisten and ensure good contact with the skin).

After the incubation period the inserts were washed carefully in PBS and MTT reduction was performed. For viability testing the inserts were placed in new 24 well plates containing 300µl of MTT solution (37°C, 1mg/mL in MTT-assay medium, delivered by Cell Systems®). The tissues were incubated for about 2 hours under cell culture conditions (5% CO2, 37°C, max humidity). The extraction of blue formazan was performed in Isopropanol (24 well plates, 2ml / insert) on a vertical shaker (at least 60 min.). For determination of cell viability the absorption of the Isopropanol-extracts were measured in duplicates at 570 nm in an automatic reader (EL808, Bio-Tek; 96 well format, 200 µL).

Substances are classified as „corrosive (R34)“, if the cell viability of the EST 1000 is decreased by more than 50% after 3 min. of incubation to the test item, or if the cell viability is less than 15% after 60 min. of exposure to the test item

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: % viability
Basis:
mean
Time point:
other: 3 min
Score:
102.99
Max. score:
100
Irritation parameter:
other: % viability
Basis:
mean
Time point:
other: 60 min
Score:
91.69
Max. score:
100

Any other information on results incl. tables

Sample No.

Test item

Time [min.]

OD mean*

StdDev

% Viability

1-3

control NaCl 0.9%

60

1.83

0.05

100.00

7-9

Aluminium-Skimmings

60

1.68

0.12

91.69

10-12

control NaCl 0.9%

3

1.80

0.09

100.00

16-18

Aluminium-Skimmings

3

1.86

0.16

102.99

Applicant's summary and conclusion

Interpretation of results:
other: not corrosive
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test item is not corrosive in a reconstructed human skin model.