Boron doped barium europium strontium silicate, orthorombic

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015-11-23 to 2015-12-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Skinethic skin irritation test -42bis Standard operating procedure (SOP) 2009

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Boron doped barium europium strontium silicate, orthorombic

EC Number:

943-065-9

Cas Number:

1800467-81-5

Molecular formula:

Sr2-x-y-zBaxEuyBzSiO4 (x=0.05-1.8; y=0.01-0.3; z=0.001-0.1; x+y<1.9)

IUPAC Name:

Boron doped barium europium strontium silicate, orthorombic

Test material form:

solid: particulate/powder

In vitro test system

Test system:

human skin model

Justification for test system used:

standard model

Vehicle:

water

Details on test system:

CELL CULTURE
- Supplier: SkinEthic Laboratories (Lyon, France).
- Source: adult human keratinocytes cultured on a polycarbonate filter in conditions which permit their terminal differentiation

Control samples:

yes, concurrent negative control

yes, concurrent vehicle

Amount/concentration applied:

16 mg test material per tissue spread with 10 µL deionized water to matching tissue size

Duration of treatment / exposure:

42 min

Duration of post-treatment incubation (if applicable):

n.a.

Number of replicates:

3

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: other: other: Optical Density, absorbance (570 nm

Value:

1.947

Remarks on result:

other:

Remarks:

Time point: 42 min. Max. score: 2.054. Remarks: mean of 3 values (2,054, 1.893, 1.895). (migrated information)

Results 2

Irritation / corrosion parameter:

other: other: Mean relative viability in %

Value:

93.92

Remarks on result:

other:

Remarks:

Time point: 42 min. (migrated information)

Other effects / acceptance of results:

Optical density (as a marker of cell viability) of test item is comparable to value of the negative control. The test is to be considered as valid because:
a) optical density of negative control (mean value: 2.074+/-2.9%) > 0.8 and < 3.0 and standarad deviation <= 18%. Historical mean= 1.423
b) relative cell viability of the positive control (mean value: 1.10; standard deviation 2.22%) < 3.42% and standard deviation <= 18%
c) standard deviation of test item < 18%

Any other information on results incl. tables

Group	Time / [min]	Mean OD	Mean Relative viability / [%]
Negative Control	42	2.074	100
Positive Control	42	0.023	1.10
Test Material	42	1.947	93.92

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. The test material was not irritating in this in vitro assay.

Executive summary:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. The test material was negative in this assay.