Strontium nitrate

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

4.5 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of acute toxicity – oral endpoint
reliable GLP guideline study available

Justification for selection of acute toxicity – inhalation endpoint
reliable GLP guideline study available

Justification for selection of acute toxicity – dermal endpoint
Acute dermal toxicity study does not need to be performed since an acute inhalation toxicity study is available which is considered to be the major route of exposure for this substance. According to the data requirements as outlined in Annexes VII-VIII, 8.5 of Regulation (EC) 1907/2006 the choice for the second route of exposure shall depend on the likely route of human exposure. Furthermore, following the HERAG guidance for metals and metal salts (see section 7.1.2 of the technical dossier, dermal absorption), a dermal absorption rate in the range of maximally 0.1-1.0 % can be anticipated. Dermal absorption in this order of magnitude is not considered to be “significant”.

Justification for classification or non-classification

Acute oral toxicity

There is one reliable study for acute oral toxicity testing performed by Notox in 2010 according to the current valid EC guideline. The LD50 was determined to be > 2000 mg/kg bw. Hence, no classification and labelling is required for the test substance.

Specific target organ toxicant (STOT) – single exposure: oral

The classification criteria according to regulation (EC) 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value, oral for a Category 1 classification of 300 mg/kg bw and at the guidance value, oral for a Category 2 classification of 2000 mg/kg bw in addition to this effects which were responsible for the death of the animals. No classification required.

Acute dermal toxicity

Following the HERAG guidance for metals and metal salts (see section 7.1.2 of the technical dossier, dermal absorption), a dermal absorption rate in the range of maximally 0.1-1.0 % can be anticipated. Dermal absorption in this order of magnitude is not considered to be “significant”.

In conclusion, testing for acute toxicity of strontium nitrate via the dermal route is not required according the criteria laid down in Annex VIII, point 8.5.

Thus, concerning dermal toxicity of strontium nitrate, following the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item shall not be classified as acutely toxic via the dermal route. According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not to be classified.

Acute inhalation toxicity

There is one study on acute toxicity, inhalation available. This study was performed with a limit concentration of 4.5 mg/L +- 0.6 mg/L strontium nitrate. One out of ten animals died within the observation period (after 2 hours after start of exposure). According to the regulation (EC) 1272/2008 the threshold value for LC50 is > =5 mg/L. It can be stated that the LC50 of strontium nitrate is > 5 mg/L and therefore the classification and labelling according to GHS is not required.

Specific target organ toxicant (STOT) – single exposure: inhalation

Laboured respiration was observed for two males between approximately 1.5 and 3.5 hours after start of exposure, including the male that was found dead.

Hunched posture, lethargy, rales, gasping, piloerection, chromodacryorrhoea and/or ptosis were observed among three males mainly between Days 1 and 6 after exposure. Rates were also observed during the second week of the observation period. No clinical signs were noted among the other animals. It can be concluded that these effect observed in two and three animals (out of ten), respectively are not sufficient for classification.