Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

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

An 90 day feeding study with the substance analogue strontium chloride hexahydrate was performed (Kroes, R; Den Tonkelaar, EM; Minderhoud, A; Speijers, GJA; Vonk-Visser (1977)). In this study, the reproductive organs including ovaries or testes, uterus or prostate were examined as well. The relative prostate weights were statistically significantly decreased at 75 and 1200 ppm (28.1% and 21% reduction resp.). Based on the absence of histopathological changes and the absence of a dose-relationship, the effects on prostates were considered not toxicologically relevant. No other effects on reproductive organs were found in this study. Although the study was not performed according to OECD guidelines, or GLP Principles, it is a well-documented study and fulfils the data requirements of OECD guideline 408 with regard to the most important parameters.


Short description of key information:
In an 90 day feeding study with the substance analogue strontium chloride hexahydrate, no toxicologically relevant effects on reproductive organs were found. Based on this, it is concluded that further testing of strontium hydrogen phosphate for potential effects on reproduction is not necessary as the current data are considered to be sufficient to fulfil the information requirements for REACH Annex VIII with regard to reproductive toxicity. The justification for waiving the OECD 421 study, to address reproductive toxicity of the substance in accordance with REACH Annex VIII, is attached in IUCLID section 13.

Effects on developmental toxicity

Description of key information
One publication on substance analague strontium nitrate is available, which is used as supplementory information (Klimisch 4). The justification for waiving a screening study to address developmental toxicity of the test substance is attached in section 13. 
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

The current data set on developmental toxicity is limited, as the available study by Lansdown et al (1971) is not equivalent to an OECD 421 screening study (Klimisch 4 rated study). Although the target organ of strontium is known (strontium replaces calcium in the bone), the implications during (early) pup development are unclear. The data requirements for REACh ANNEX VIII require a reproduction/ screening study. Based on the observations in the studies evaluated, no effects on foetal/pup number, survival, growth and appearance are to be expected. Potential effects caused by replacement of calcium from bones will most probably not be visible externally, and are thus expected to be invisible in a screening study. Based on these considerations, it is concluded that it is scientifically and ethically not justified to perform a reproduction/ developmental screening study.

Justification for classification or non-classification

Based on the available data, Strontium hydrogenphosphate is not classified for effects on reproduction and/or developmental toxicity according to Regulation (EC) No 1272/2008.