Registration Dossier
Registration Dossier
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EC number: 240-894-1 | CAS number: 16871-71-9
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- other: evidence based on degradation product
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Referenceopen allclose all
- Title:
- European Union Risk Assessment Report - hydrogen fluoride
- Year:
- 2 001
- Bibliographic source:
- Luxembourg: Office for Official Publications of the European Communities, 2001
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Zinc hexafluorosilicate
- EC Number:
- 240-894-1
- EC Name:
- Zinc hexafluorosilicate
- Cas Number:
- 16871-71-9
- Molecular formula:
- F6Si.Zn
- IUPAC Name:
- zinc(2+) hexafluorosilanediuide
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: gas
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/m³ air (analytical)
- Dose / conc.:
- 0.098 mg/m³ air (analytical)
- Dose / conc.:
- 0.72 mg/m³ air (analytical)
- Dose / conc.:
- 7.52 mg/m³ air (analytical)
- No. of animals per sex per dose:
- 20
- Details on study design:
- In a 91 days subchronic study (Placke and Griffin 1991), also performed according to GLP with similarity to OECD 413 guideline, female and male rats (20/group) were exposed to 0, 0.082, 0.816 and 8.16 mg HF/m3 (nominal concentrations; actual concentrations were: 0, 0.098, 0.72
and 7.52 mg/m3, respectively) for 6 hours/d, 5 days/week.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 0.72 mg/m³ air (analytical)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical biochemistry
- clinical signs
- haematology
- mortality
- organ weights and organ / body weight ratios
Applicant's summary and conclusion
- Conclusions:
- From EU Risk Assessment Report on hydrogen fluoride:
The available animal data set for HF permits the derivation of a NOAEL for repeated sub- chronic inhalatory exposure. No suitable studies are available for HF, for other routes of exposure. The over-all NOAEL for repeated inhalatory exposure is taken from the 91-day GLP study with female and male rats and amounts 0.72 mg HF/m3 (actual value) for a 6 h per d 5 d per week exposure regimen. At this exposure no adverse effects were observed. At the next exposure level death, tissue irritation, dental malformations, haematological and biological changes and changes in several organ weights were observed.
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