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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:
weight of evidence
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The study has been properly conducted, in accordance with recommended guidelines.

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:
other: EU method B.40bis
Deviations:
no
Qualifier:
according to
Guideline:
other: OECD 431 Guideline
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sample 10.058461.01 was tested.

Test animals

Species:
human
Strain:
other: human skin model (EPISKIN)

Test system

Type of coverage:
other: not applicable
Preparation of test site:
other: not applicable
Vehicle:
water
Controls:
other: Negative control: water
Amount / concentration applied:
For test sample 25 mg of substance was applied evenly to cover the skin, and it was moistened with distilled water to ensure good contact with the skin.
Duration of treatment / exposure:
The assessment of skin corrosivity was carried out in two contact times according to OECD 431: 3 min and 1 h.
Observation period:
At the end of the exposure period, each tissue insert was washed with DPBS for twenty times from the skin surface. Every tissue replicate was treated in 0.3 ml of MTT solution 1 mg/mL. The plate was incubated for 3 hr at 37°C ± 1°C 5 % CO2. At the end of incubation each tissue insert was treated with 2ml of Isopropyl alcohol (dark, T room, overnight). Two replicates of extract solution (200 μl) were put into microplate’s wells and the optical density (OD) of the extracted (solubilised) dye at 570 nm was evaluated.
Number of animals:
For each contact time, three tissue replicates were used for sample treatment, three for positive control and three for the negative one.

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other: other: Cell viability (%) after application of the test substance
Value:
98.78
Remarks on result:
other:
Remarks:
Basis: mean. Time point: Contact time 3 min. Remarks: Viability (%) = (mean OD570 / mean OD570 negative control) x 100. (migrated information)
Irritation / corrosion parameter:
other: other: Cell viability (%) after application of the positive control
Value:
22.06
Remarks on result:
other:
Remarks:
Basis: mean. Time point: Contact time 3 min. Remarks: Viability (%) = (mean OD570 / mean OD570 negative control) x 100. (migrated information)
Irritation / corrosion parameter:
other: other: Cell viability (%) after application of the test substance
Value:
100.07
Remarks on result:
other:
Remarks:
Basis: mean. Time point: Contact time 1 h. Remarks: Viability (%) = (mean OD570 / mean OD570 negative control) x 100. (migrated information)
Irritation / corrosion parameter:
other: other: Cell viability (%) after application of the positive control
Value:
0.56
Remarks on result:
other:
Remarks:
Basis: mean. Time point: Contact time 1 h. Remarks: Viability (%) = (mean OD570 / mean OD570 negative control) x 100. (migrated information)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to "In vitro Skin Corrosion Human Skin Model Test" Barium Hexaferrite was not corrosive for skin.
Executive summary:

Barium hexaferrite was tested in an in vitro model for skin corrosion (EPISKIN) according to EU B.40bis/OECD 431 guidelines. The substance was not corrosive for the skin.