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Administrative data

Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because inhalation of the substance is likely
Justification for type of information:
According to the §8.5.3, column 2 of the annex VIII of REACh, testing is not appropriate for dermal route since inhalation of the substance is likely and acute toxicity data by inhalation route is provided.
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
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.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

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