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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

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Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

No reproductive toxicity study with strontium oxide is available. Since strontium oxide completely dissolves upon contact and during the reaction with water andbased on the assumption that strontium is the moiety of concern,the toxicity to reproduction will be addressed only with existing data on the moiety strontium. 

In a sub-chronic repeated dose toxicity study conducted with strontium chloride, no adverse effects on reproduction were reported. Thus, strontium oxide in all probability has also no potential to induce toxicity to reproduction.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Strontium

No histological changes for uterus, ovaries, testes and prostate after the administration of up to and including 4800 ppm strontium chloride hexahydrate were observed in an sub-chronic oral repeated dose toxicity study OECD 408 (Kroes, 1977). The authors reported a NOAEL of 4800 ppm, which is equivalent to a strontium concentration of 157.7 mg/kg bw.

In accordance with regulation 1907/2006 (EC), Annex IX, Section 8.7.3, Column 1, an extended one generation reproductive toxicity study shall be proposed, only in case the available repeated dose toxicity studies (e.g. 28-day or 90-day studies) indicate adverse effects on reproductive organs or tissues or reveal other concerns in relation with reproductive toxicity. Sufficient weight of evidence is available to demonstrate an absence of reproductive toxicity and that testing on vertebrate animals in an extended one- generation reproductive toxicity study (OECD 443) with strontium oxide shall be omitted.

Strontium oxide

Strontium oxide is not expected to show adverse effects on reproduction, since the moiety of concern strontium has not shown adverse effects on sexual function and fertility parameters analysed in a relevant repeated dose toxicity study. Thus, strontium oxide in all probability has also no potential to induce adverse effects and is not to be classified according to regulation (EC) 1272/2008 as reproductive toxicant: fertility impairment.

An extended one generation reproductive toxicity test with strontium oxide is not required according to regulation 1907/2006 (EC), Annex IX, Section 8.7.3, Column 1. For further information on the toxicity of strontium, please refer to the relevant section in the IUCLID and CSR.

For the purpose of hazard assessment of strontium oxide, the point of departure for the most sensitive endpoint of strontium, as moiety of concern, will be used for the DNEL derivation. Thus, the NOAEL of 9.9 mg Sr/kg bw/day for the repeated dose toxicity will be used.

Effects on developmental toxicity

Description of key information

No developmental toxicity study with strontium oxide is available. Since strontium oxide completely dissolves upon contact and during the reaction with water andbased on the assumption that strontium is the moiety of concern,the developmental toxicity will be addressed only with existing data on the moiety strontium. 

In a prenatal developmental toxicity study conducted with strontium dinitrate, no adverse effects were reported. Since the moiety of concern strontium did not induce adverse effects, strontium oxide in all probability has also no potential to induce developmental toxicity. However, since some limitation were noted in the prenatal developmental toxicity study and this study is not suitable for hazard or risk assessment purposes, a testing proposal for a prenatal developmental toxicity study with strontium oxide is included.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Strontium

In a prenatal developmental toxicity study performed by Landsdown (1972) strontium nitrate were administered to rats subcutaneously between pregnancy day 9 to 19. No maternal toxicity was observed up to doses of 200 mg/kg bw of strontium nitrate. Litter sizes were similar and the number of resorption sites was not increased. Therefore, no embryotoxicity was observed. According to the authors, the results indicate that high maternal doses of strontium nitrate (25, 50, 100 or 200 mg/kg bw/day; equivalent to 10.3, 20.7, 41.4, or 82.8 mg Sr/kg bw/day) were not teratogenic when given at a maximum period of bone development.

Strontium oxide

Since no developmental toxicity study is available for strontium oxide, information on the moiety of concern strontium will be used for the hazard assessment.

No adverse effects on development were noted in a prenatal developmental toxicity study conducted with strontium dinitrate. However, some limitations of the study design were reported and thus no final conclusion on risk assessment and classification for strontium oxide can be made. Thus, a testing proposal for a prenatal developmental toxicity study with strontium oxide is included.

Justification for classification or non-classification

No adverse effects were observed in a sub-chronic repeated dose toxicity study conducted with strontium chloride. Thus, strontium oxide in all probability has also no potential to induce adverse effects on reproduction.

As the moiety of concern strontium did not show any adverse effect in a prenatal developmental toxicity study, strontium oxide in all probability has also no potential to induce developmental toxicity.

However, since this study is not suitable for hazard or risk assessment purposes, no final conclusion on classification and labelling for strontium oxide can be drawn. A testing proposal for a prenatal developmental toxicity study is included.

Additional information