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Description of key information

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:
As few data are available on the target substance, a research of the potential analogues has been carried out.
The hypothesis is that properties are likely to be similar or follow a similar pattern as a result of the presence of a common metal ion (or ion complex including a hydrated metal ion). This is a reasonable assumption for the majority of inorganic compounds and some organic compounds (e.g. metal salts of some organic acids).
The following points are be considered:
- Chemical speciation and valency,
- 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.
- Counter ions: the assumption that the metal ion is responsible for the common property or effect implies that the toxicity of the counter ion present in the compound will be largely irrelevant in producing the effects to be assessed.
Based on these data, we have selected the analogue Strontium nitrate .
Strontium has also physiochemical properties similar to calcium and both appear mainly in ionic form in water.

A detail description is provided as attached report of this endpoint in this Iuclid file.
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 Strotium di(acetate) 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

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2010-06-14 to 2010-06-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study reliable without restrictions
Justification for type of information:
As few data are available on the target substance, a research of the potential analogues has been carried out.
The hypothesis is that properties are likely to be similar or follow a similar pattern as a result of the presence of a common metal ion (or ion complex including a hydrated metal ion). This is a reasonable assumption for the majority of inorganic compounds and some organic compounds (e.g. metal salts of some organic acids).
The following points are be considered:
- Chemical speciation and valency,
- 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.
- Counter ions: the assumption that the metal ion is responsible for the common property or effect implies that the toxicity of the counter ion present in the compound will be largely irrelevant in producing the effects to be assessed.
Based on these data, we have selected the analogue Strontium nitrate .
Strontium has also physiochemical properties similar to calcium and both appear mainly in ionic form in water.

A detail description is provided as attached report of this endpoint in this Iuclid file.
Reason / purpose for cross-reference:
read-across source
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 4.5 other: mg/l water (analytically verified)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: Standard deviation: 0.6 mg/l
Mortality:
One male was found dead approximately 2 hours after start of exposure. No further mortality occurred.
Clinical signs:
other: 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 observ
Body weight:
Body weight gain of surviving males and females was within the range expected for rats of this strain and age used in this type of study.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Other findings:
No data
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The inhalatory LC50, 4h value of strontium nitrate in Wistar rats was considered to be 4.5 +/- 0.6 mg/l.
Based on these results Strontium Nitrate does not have to be classified and has no obligatory labeling requirement for acute inhalation toxicity according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as acute toxic by the inhalation route.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
4.5 mg/m³

Additional information

Justification for selection of acute toxicity – oral endpoint

reliable GLP guideline study available and valid based on a read-across approach

Justification for selection of acute toxicity – inhalation endpoint

reliable GLP guideline study available and valid based on a read-across approach

Justification for classification or non-classification

For oral toxicity and inhalation toxicity, a read-across approach was used and the results were considered valid for determining 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 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.

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