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Toxicological information

Acute Toxicity: inhalation

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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:
1962

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

Constituent 1
Chemical structure
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

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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