Registration Dossier
Registration Dossier
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EC number: 231-668-3 | CAS number: 7681-52-9
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Deficiencies: Yes. Only males were tested, duration of treatment only 1 hour, actual test atmosphere was not analytically determined, particle size was not determined, no batch number indicated. Although some aspects of the study do not meet up-to-date standards, the results are reliable and sufficient for risk assessment. New studies are not required and should not be conducted due to animal welfare considerations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 962
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Public avaialble literature. No guideline indicated. For details on method see materials and methods section in IUCLID5 dossier.
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Sodium hypochlorite
- EC Number:
- 231-668-3
- EC Name:
- Sodium hypochlorite
- Cas Number:
- 7681-52-9
- Molecular formula:
- ClO.Na
- IUPAC Name:
- sodium hypochlorite
- Details on test material:
- Sodium hypochlorite
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Age not stated, mean weight 177 g.
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- not specified
- Vehicle:
- other: no data
- Details on inhalation exposure:
- Six male albino rats were exposed to an atmosphere containing 10.5 mg sodium hypochlorite/L for duration of 1 hour.
- Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 1 h
- Concentrations:
- 10.5 mg/L
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- Six male albino rats were exposed to an atmosphere containing 10.5 mg sodium hypochlorite/L for duration of 1 hour. The animals were observed for signs of toxicity during exposure and for 14 days thereafter. Body weights were recorded at study initiation and termination. A gross necropsy was performed.
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 10.5 mg/L air
- Exp. duration:
- 1 h
- Mortality:
- no mortality
- Clinical signs:
- other: Generalised inactivity, lacrimation
- Body weight:
- No significant findings
- Gross pathology:
- No significant findings
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Clinical signs included generalised inactivity and lacrimation. Gross autopsy did not reveal any significant findings.
The LC50 was determined to be greater than 10.5 mg/L.
Although the documentation appears to be of limited quality the applicant is of the opinion that all relevant data are available, all major issues
concerning acute inhalation toxicity are addressed and the annex point is sufficiently covered by this study. - Executive summary:
Materials and methods
Six male albino rats were exposed to an atmosphere containing 10.5 mg sodium hypochlorite/L for duration of 1 hour. The animals were observed for signs of toxicity during exposure and for 14 days thereafter. Body weights were recorded at study initiation and termination. A gross necropsy was performed.
Results and discussion
Clinical signs included generalised inactivity and lacrimation. Gross autopsy did not reveal any significant findings. The LC50 was determined to be greater than 10.5 mg/L.
Although the documentation appears to be of limited quality the applicant is of the opinion that all relevant data are available, all major issues concerning acute inhalation toxicity are addressed and the annex point is sufficiently covered by this study.
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