Registration Dossier
Registration Dossier
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EC number: 242-367-1 | CAS number: 18480-07-4
Endpoint summary
Administrative data
Description of key information
Acute toxicity, oral: data waiving; read-across from Sr(NO3)2: LD50 > 1149 mg/kg bw (> 828 mg Sr/kg bw).
Acute toxicity, inhalation: data waiving
Acute toxicity, dermal: data waiving
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 1 149 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity:
No acute toxicity study by oral route is available on Strontium hydroxide itself and no study was performed due to the corrosive properties of the substance (section 8.5, column 2, Annex VII of regulation (EC) 1907/2006).
However, an analogue approach is used for the read-across of acute oral toxicity properties of strontium hydroxide from strontium nitrate, based on the hypothesis that properties are likely to be similar as a result of the presence of a common metal ion Sr2+. Further information on the read-across justification is included as attachment in Section 13.
Acute inhalation toxicity
According to section 8.5, column 2, Annex VII of regulation (EC) 1907/2009, no study on acute toxicity via inhalation should be conducted due to the corrosive properties of the substance (pH >11.5). As a worst case assumption, the substance has to be classified as “corrosive to the respiratory tract” (EUH071).
Acute dermal toxicity
According to section 8.5, column 2, Annex VII of regulation (EC) 1907/2009, no study on acute toxicity via dermal route should be conducted due to the corrosive properties of the substance (pH >11.5). In addition, strontium hydroxide is not used in consumer products and due to the fact that the substance is classified as corrosive, the worker has to use sufficient gloves (see “guidance on safe use”). Since skin contact is unlikely and therefore absorption through skin is only possible in case of an accident, no acute dermal toxicity study was conducted.
Justification for classification or non-classification
Acute oral toxicity
Based on the read-across approach from Strontium nitrate, the LD50 of Strontium hydroxide is expected to be > 1149 mg/kg body weight and no classification and labelling is anticipated.
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 inhalation toxicity
According to section 8.5, column 2, Annex VIII of regulation (EC) 1907/2009, no study on acute toxicity via inhalation should be conducted due to the corrosive properties of the substance (pH >11.5). As a worst case assumption the substance has to be classified as “corrosive to the respiratory tract” (EUH071).
Acute dermal toxicity
According to section 8.5, column 2, Annex VIII of regulation (EC) 1907/2009, no study on acute toxicity via dermal route should be conducted due to the corrosive properties of the substance (pH >11.5). As a worst case assumption the substance has to be classified as “corrosive to the skin”.
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”.
Thus, according to the EC Regulation No. 1272/2008 and subsequent regulations, strontium hydroxide is not to be classified.
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