Boron doped barium europium strontium silicate, orthorombic

Endpoint summary

Description of key information

This studies relevant for these endpoints were performed according to GLP and the methods applied were fully compliant with OECD TG 437 and 439. The test material was not irritating to skin and not irritating to eye in vitro.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

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

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)

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%

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015-11-20 to 2015-11-27

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Vehicle:

physiological saline

Controls:

yes, concurrent vehicle

yes, concurrent positive control

Amount / concentration applied:

750 µL (i.e. 150mg/750µL) of test item, negative or positive control

Duration of treatment / exposure:

240 minutes

Number of animals or in vitro replicates:

in vitro: triplicate design

Irritation parameter:

in vitro irritation score

Run / experiment:

run 1

Value:

113.9

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Irritation parameter:

cornea opacity score

Run / experiment:

run 1

Value:

62.2

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Irritation parameter:

fluorescein leakage

Run / experiment:

run 1

Value:

3.45

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

		Opacity	Permeability	IVIS
				per cornea	per group (mean value)	SD
Negative Control	0.9 % NaCl Solution	-0.062	-0.001	-0.082	0.8	0.9
		1.816	-0.001	1.801
		0.706	-0.001	0.696
Positive Control	20 % Imidazole  solution	70.793	2.142	102.928	106.6	4.1
		71.315	2.303	105.860
		79.270	2.119	111.060
Test material	Art. 132039	66.507	3.447	118.217	113.9	16.4
		72.337	3.699	127.827
		47.660	3.206	95.780

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Remarks:

Migrated information

Conclusions:

Under the given experimental conditions the test material the test material has ocular corrosive potential.

Executive summary:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 437. The test material was corrosive in this in vitro assay.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

No effects have been observed in in vitro assays as outlined above.