Strontium peroxide

Endpoint summary

Description of key information

The oral LD50 value of Strontium Nitrate in Wistar rats was established to exceed 2000 mg/kg body weight. Considering the read-across approach the LD50 for strontium peroxide is considered similar.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study reliable without restrictions

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

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One female was found dead within 4 hours post-treatment on Day 1. No further mortality occurred.

Clinical signs:

Lethargy, hunched posture, piloerection and/or ptosis were noted for all animals and the surviving animals had recovered from all symptoms on Day 4 or Day 6. In addition to these symptoms, flat posture and slow breathing were observed for the animal that was found dead on Day 1.

Body weight:

The body weight gain shown by the surviving animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.

Gross pathology:

Macroscopic post mortem examination of the animal that was found dead on Day 1 revealed several dark red foci on the glandular mucosa of the stomach. No abnormalities were found at macroscopic post mortem examination of the animals that survived until termination.

Other findings:

No data

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 value of Strontium Nitrate in Wistar rats was established to exceed 2000 mg/kg body weight. Considering the read-across approach the LD50 for strontium peroxide is considered similar.
According to the Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures, the substance does not have to be classified and has no obligatory labeling requirement for oral toxicity.
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the substance is not classified as acute toxic by the oral route.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Justification for classification or non-classification

The oral LD50 value on rats which was established to exceed 2000 mg/kg body weight is considered for strontium peroxide.

According to the Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures, the substance does not have to be classified and has no obligatory labelling requirement for oral toxicity. According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the substance is not classified as acute toxic by the oral route.