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Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
no data
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study not performed according to a guideline and not GLP. No details concerning material and method and few details on results are available. Animals were only exposed 4 hours/d. No data on actual concentration in air. Clinical chemistry, haemathology, ophthalmoscopic examination, neurobehaviour and food and water analyses were not performed. Statistical analysis is not reported.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Chlorine dioxide - Toxicity in animal experiments and industrial risks.
Author:
Dalhamn, T
Year:
1957
Bibliographic source:
A.M.A. Archives of Industrial Health. 15: 101-107

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Ten rats were involved; five were controls and five exposed once a day for 4 hours/day for 9 days in a 13-day period to approximately 10 ppm.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Chlorine dioxide
EC Number:
233-162-8
EC Name:
Chlorine dioxide
Cas Number:
10049-04-4
Molecular formula:
ClO2
IUPAC Name:
Chlorine dioxide generated from sodium chlorate and hydrogen peroxide in the presence of a strong acid
Details on test material:
chlorine dioxide gas (purity and batch number not stated)

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data

Administration / exposure

Route of administration:
inhalation: gas
Type of inhalation exposure:
not specified
Vehicle:
other: gas
Remarks on MMAD:
MMAD / GSD: No data
Details on inhalation exposure:
Compressed air and ClO2 gas ( the latter via air bubbled through a solution of ClO2) were mixed in a mixing chamber. After passing through the exposure chamber, ClO2 gas was allowed to escape either through a fume cupboard or through a Peligot tube containing KI solution and via a drying tower through a gas meter (when the mixture was sampled).
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
No data
Duration of treatment / exposure:
9 days
Frequency of treatment:
4 hours/day for 9 days in a 13-day period
Doses / concentrations
Remarks:
Doses / Concentrations:
0 and 10 ppm (0 and 28 mg/m3)
Basis:
nominal conc.
No. of animals per sex per dose:
5 rats/dose
Control animals:
yes, sham-exposed
Details on study design:
No data
Positive control:
No

Examinations

Observations and examinations performed and frequency:
Urine was examined for protein, and the weight of the rats was charted.
Sacrifice and pathology:
No data
Other examinations:
No data
Statistics:
No data

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
One rat died after 10 days' exposure, and two died after a further day. The two remaining rats died on the 13th day
Mortality:
mortality observed, treatment-related
Description (incidence):
One rat died after 10 days' exposure, and two died after a further day. The two remaining rats died on the 13th day
Body weight and weight changes:
effects observed, treatment-related
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
acute renal and hepatic congestion
Histopathological findings: neoplastic:
not specified
Details on results:
The exposed rats showed marked distress in the form of rhinorrhea and embarrassed respiration. The number of positive urinary protein tests was not greater in the exposed rats than in the controls. The weight of the exposed rats, however, showed a mean reduction of about 80 gm, while that of the controls was largely unaltered. One rat died after 10 days' exposure, and two died after a further day. The two remaining rats died on the 13th day. The kidneys, liver, and lungs were examined. In all the exposed rats microscopy showed changed resulting from respiratory infection with acute renal and hepatic congestion. Nothing of note was seen in the control rats.

Effect levels

Dose descriptor:
LOAEC
Effect level:
28 mg/m³ air (nominal)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: rhinorrhoea and embarrassed respiration

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

No data

Applicant's summary and conclusion

Conclusions:
The LOAEC in this study is 28 mg/m3, based on respiratory effects.
Executive summary:

In a subacute study, rats (5 per group) were exposed to Chlorine Dioxide by gas inhalation at dose level of 0 and 10 ppm (0 and 28 mg/m3), 4 h/d for 9 days in a 13 -day period.

Urine was examined for protein, and the weight of the rats was charted. At the end of the experiment, animals were sacrified and kidneys, liver and lungs were examined at necropsy.

The exposed rats showed marked distress in the form of rhinorrhea and embarrassed respiration.

The number of positive urinary protein tests was not greater in the exposed rats than in the controls.

The weight of the exposed rats, however, showed a mean reduction of about 80 mg, while that of the controls was largely unaltered.

One rat died after 10 days' exposure, and two died after a further day. The two remaining rats died on the 13th day.

The kidneys, liver, and lungs were examined. In all the exposed rats microscopy showed changed resulting from respiratory infection with acute renal and hepatic congestion.

The LOAEC in this study is 28 mg/m3, based on respiratory effects.