Strontium peroxide

Endpoint summary

Description of key information

According to an OECD 439 study, strontium peroxide is not irritant to skin. Based on a read across approach, strontium peroxide can be considered as non irritant to eye.

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:

2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source of test material: Bernardy, Peroxyde de strontium, code SRO20
- batch No.: 1703028
- Purity test date: 20/03/2017
- date of reception: 19/12/2017
- Expiry date: 20/03/2020

STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

Test system:

human skin model

Justification for test system used:

Test system recommended in the OECD 439 Guideline.

Vehicle:

water

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: SkinEthic RHE® model
- Tissue batch number(s): 18-RHE-027
- Delivery date: received on 13 March 2018

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C

REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 42 minutes after the test item application, the nylon mesh was removed and the human epidermises were washed with 25 x 1 mL of DPBS (Dutscher - Batch No. 5691217).
- Observable damage in the tissue due to washing: No (comparable coloration to that of the negative control tissues)

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 42 hours post-treatment incubation period (after 42 min of exposure)

FUNCTIONAL MODEL CONDITIONS
- Viability:
Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues. The mean percent viability of the treated tissues was 90.3% versus 1.3% in the positive control (5% Sodium Dodecyl Sulfate).
The results were expressed as a viability percentage compared with the negative control : Viability % = OD test item / OD negative control x100

NUMBER OF REPLICATE TISSUES:
Three replicates used for each test chemical and for the controls : 3 replicates for test item, 3 for negative control, 3 for positive control

PREDICTION MODEL / DECISION CRITERIA
The test item is considered as non-irritant to skin in accordance with UN GHS No Category if the mean percent viability after 42 minutes exposure and 42 hours of post-treatment incubation is > 50%.
The test item is identified as requiring classification and labelling according to UN GHS (Category 2) if the mean percent tissue viability after 42 minutes exposure and 42 hours of post-treatment incubation is ≤ 50% and the result of a skin corrosion test is “non-corrosive”.
The test item is identified as requiring classification and labelling according to UN GHS (Category 2 or Category 1) if the mean percent tissue viability after 42 minutes exposure and 42 hours of post-treatment incubation is ≤ 50% and in absence of information on a skin corrosion test.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount applied: dose of 16 mg to the epidermal surface of 3 living Reconstructed Human epidermis previously moistened with 10 μL of distilled water.

VEHICLE
- Amount(s) applied (volume or weight with unit): Reconstructed Human epidermis previously moistened with 10 μL of distilled water.

NEGATIVE CONTROL
DPBS – Dutscher - Batch No. 3941117
- Amount applied: 0.5 g of SDS (SIGMA Batch No. STBG6142V) in a 10 mL volumetric flask qsp 10 mL of distilled water.

POSITIVE CONTROL
5% sodium dodecyl sulfate (SDS)
- Amount applied: in a 10 mL volumetric flask

Duration of treatment / exposure:

42min (application)

Duration of post-treatment incubation (if applicable):

42 hours

Number of replicates:

3 for each test chemical and for the controls (3 replicates for test item, 3 for negative control, 3 for positive control).

Irritation / corrosion parameter:

% tissue viability

Value:

90.3

Negative controls validity:

valid

Positive controls validity:

valid

Interpretation of results:

GHS criteria not met

Conclusions:

In accordance with the Regulation EC No. 1272/2008, the test item STRONTIUM PEROXIDE has to be considered as Non-irritant to skin. It corresponds to UN GHS No Category.
No hazard statement or signal word is required.

Executive summary:

An OECD 439 test was performed on Strontium peroxide in order to investigate the corrosion/irritation potential. In accordance with the Regulation EC No. 1272/2008, the test item STRONTIUM PEROXIDE has to be considered as Non-irritant to skin. It corresponds to UN GHS No Category. No hazard statement or signal word is required.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information in a detailed justification report is included as attachment to the same record.

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
For the determination of analogue in this read-across approach, the following points have been considered:
- Chemical speciation and valency (common strontium cation: Sr2+).
- The water solubility, as it provides a first indication of the availability of the metal ion in the different compartments of interest. The most simplistic approach to hazard evaluation is to assume that the specific metal-containing compound to be evaluated shows the same hazards as the most water-soluble compounds.
- In fluids of organisms and in in aqueous media, dissociation of strontium peroxide takes place immediately, resulting in formation of strontium cations (Sr2+) and oxygen. Thus, any ingestion or absorption of strontium peroxide by living organisms, in case of systemic consideration, will inevitably result of exposure to the dissociation products.
- Oxygen (formed during the dissociation of strontium peroxide) is of low (eco)toxicological relevance when ingested and taken up systemically. Thus, any possible toxicological or ecotoxicological effect triggered by strontium peroxide exposure can be attributed to strontium.
- Counter ions: the assumption that the metal ion is responsible for the common property or effect implies that the toxicity or ecotoxicity of the counter ion present in the compound will be largely irrelevant in producing the effects to be assessed.
- Likely common breakdown products via physical and/or biological processes for the targeted substance (strontium peroxide) and the analogues identified cannot present strong differences since the structures are very simple and very similar (formation of Sr2+ ion).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source chemical information is provided in the “source” endpoint. No impurity affecting the classification is reported for the source chemical.
Information on the impurities of the target chemical are detailed in the attached report.

3. ANALOGUE APPROACH JUSTIFICATION
The main hypothesis for the analogue approach are verified. They are presented in the detailed report attached. The experimental data performed on the substance (tests performed in this REACH registration dossier on strontium peroxide) confirms the analogue approach performed (same results on analogues).

4. DATA MATRIX
A data matrix is presented in the detailed report attached.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

The ocular reactions observed during the study have been slight and totally reversible:
- at the conjunctivae level: a slight redness noted 1 hour after the test item instillation in all animal and totally reversible between Days 1 and 2. This reaction was associated with a slight chemosis noted 1 hour after the test item instillation in all animals and totally reversible between day 1 and day 2.
- at the corneal level: a slight opacity noted 24 hours after the test item instillation in one animal and totally reversible on day 2.

Animal n° Weiht (kg)	Time after treatment	CONJUCTIVAE		IRIS	CORNEA
		CHEMOSIS (A)	REDNESS (C)	LESION (D)	OPACITY (E)
A7105	24 hours	0	0	0	1
	48 hours	0	0	0	0
	72 hours	0	0	0	0
Start: 2.09	TOTAL	0	0	0	1
End: 2.24	Mean	0.0	0.0	0.0	0.3
A7092	24 hours	1	1	0	0
	48 hours	0	0	0	0
	72 hours	0	0	0	0
Start: 2.55	TOTAL	0	0	0	0
End: 2.67	Mean	0.3	0.3	0.0	0.0
A7093	24 hours	0	0	0	0
	48 hours	0	0	0	0
	72 hours	0	0	0	0
Start: 2.71	TOTAL	0	0	0	0
End: 2.84	Mean	0.0	0.0	0.0	0.0
CLASSIFICATION	According to the calculated means, the test item does not have to be classified

Interpretation of results:

GHS criteria not met

Conclusions:

The results obtained, under these experimental conditions, enable to conclude that based on read-across approach, STRONTIUM PEROXIDE does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
No symbol and warning label are required.

Executive summary:

The test item STRONTIUM OXALATE was instilled, as supplied, into the eye of three New Zealand rabbits at the dose of 0.1 g.

The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. Test Guideline No. 405 dated October 9th, 2017.

The ocular reactions observed during the study have been slight and totally reversible:

- at the conjunctivae level: a slight redness noted 1 hour after the test item instillation in all animal and totally reversible between Days 1 and 2. This reaction was associated with a slight chemosis noted 1 hour after the test item instillation in all animals and totally reversible between day 1 and day 2.

- at the corneal level: a slight opacity noted 24 hours after the test item instillation in one animal and totally reversible on day 2.

In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item STRONTIUM OXALATE, and thus based on a read-across approach, STRONTIUM PEROXIDE, does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.

No symbol and warning label are required.

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information in a detailed justification report is included as attachment to the same record.

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
For the determination of analogue in this read-across approach, the following points have been considered:
- Chemical speciation and valency (common strontium cation: Sr2+).
- The water solubility, as it provides a first indication of the availability of the metal ion in the different compartments of interest. The most simplistic approach to hazard evaluation is to assume that the specific metal-containing compound to be evaluated shows the same hazards as the most water-soluble compounds.
- In fluids of organisms and in in aqueous media, dissociation of strontium peroxide takes place immediately, resulting in formation of strontium cations (Sr2+) and oxygen. Thus, any ingestion or absorption of strontium peroxide by living organisms, in case of systemic consideration, will inevitably result of exposure to the dissociation products.
- Oxygen (formed during the dissociation of strontium peroxide) is of low (eco)toxicological relevance when ingested and taken up systemically. Thus, any possible toxicological or ecotoxicological effect triggered by strontium peroxide exposure can be attributed to strontium.
- Counter ions: the assumption that the metal ion is responsible for the common property or effect implies that the toxicity or ecotoxicity of the counter ion present in the compound will be largely irrelevant in producing the effects to be assessed.
- Likely common breakdown products via physical and/or biological processes for the targeted substance (strontium peroxide) and the analogues identified cannot present strong differences since the structures are very simple and very similar (formation of Sr2+ ion).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source chemical information is provided in the “source” endpoint. No impurity affecting the classification is reported for the source chemical.
Information on the impurities of the target chemical are detailed in the attached report.

3. ANALOGUE APPROACH JUSTIFICATION
The main hypothesis for the analogue approach are verified. They are presented in the detailed report attached. The experimental data performed on the substance (tests performed in this REACH registration dossier on strontium peroxide) confirms the analogue approach performed (same results on analogues).

4. DATA MATRIX
A data matrix is presented in the detailed report attached.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

chemosis score

Remarks:

Mean

Basis:

animal: A6670

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Remarks:

Redness (mean)

Basis:

animal: A6670

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

iris score

Remarks:

mean

Basis:

animal: A6670

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Remarks:

mean

Basis:

animal: A6670

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Remarks:

mean

Basis:

animal: A6674

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Remarks:

Redness (mean)

Basis:

animal: A6674

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

iris score

Remarks:

mean

Basis:

animal: A6674

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Remarks:

mean

Basis:

animal: A6674

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Remarks:

mean

Basis:

animal: A6675

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Remarks:

Redness (mean)

Basis:

animal: A6675

Time point:

24/48/72 h

Score:

0.7

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

iris score

Remarks:

mean

Basis:

animal: A6675

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Remarks:

mean

Basis:

animal: A6675

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible

Irritant / corrosive response data:

The ocular reactions observed during the study have been slight to moderate and totally reversible:
- At the conjunctivae level: a slight to moderate redness noted 24 hours after the test item instillation and totally reversible between days 2 and 3; associated with a slight to moderate chemosis noted 1 hour after the test item instillation and totally reversible between days 2 and 3.
- At the iris level: an injection was noted 1 hour after the test item instillation in two animals and was totally reversible on day 1.
- At the corneal level: a slight opacity, noted 24 hours after the test item instillation in two animals and totally reversible on day 2.

Interpretation of results:

GHS criteria not met

Conclusions:

The results obtained, under these experimental conditions, enable to conclude that based on read-across approach STRONTIUM PEROXIDE does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
No symbol and warning label are required.

Executive summary:

The test item STRONTIUM ACETATE was instilled, as supplied, into the eye of three New Zealand rabbits at the dose of 0.1 g. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. Test Guideline No. 405 dated October 2nd, 2012.

The ocular reactions observed during the study have been slight to moderate and totally reversible:

- At the conjunctivae level: a slight to moderate redness noted 24 hours after the test item instillation and totally reversible between days 2 and 3; associated with a slight to moderate chemosis noted 1 hour after the test item instillation and totally reversible between days 2 and 3.

- At the iris level: an injection was noted 1 hour after the test item instillation in two animals and was totally reversible on day 1.

- At the corneal level: a slight opacity, noted 24 hours after the test item instillation in two animals and totally reversible on day 2.

In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item STRONTIUM ACETATE, and based on read-across approach STRONTIUM PEROXIDE does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.

No symbol and warning label are required.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Justification for classification or non-classification

According to an OECD 439 study, strontium peroxide is not irritant to skin. Based on a read across approach, strontium peroxide can be considered as non irritant to eye. Consequently, no classification is required.