Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Published in a peer-reviewed paper, limited reporting, but otherwise acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Inhalation of calcium chloride aerosols in complex therapy of pulmonary tuberculosis.
Author:
Vinnikov PL, Slepova RI, Sataev IF
Year:
1962
Bibliographic source:
Kazan Med Zh. , 4, 7-9

Materials and methods

Study type:
other: tuberculosis patients treatment
Endpoint addressed:
acute toxicity: inhalation
Principles of method if other than guideline:
Sixty five tuberculosis patients (51 males, 14 females; age from below 30 till over 50) were treated with aerosol inhalations of 2-5% aqueous solution of calcium chloride. The number of inhalations varied from below 10 (24 patients), till over 30 (2 patients). Clinical signs are reported.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No data.

Method

Type of population:
other: tuberculosis patients
Subjects:
- Number of subjects exposed: 65
- Sex: 51 males, 14 females
- Age: below 30: 17, from 31 to 50: 39, over 50: 9
- Race: unknown
- Demographic information: unknown
- Known diseases: tuberculosis
Ethical approval:
not specified
Route of exposure:
inhalation
Reason of exposure:
intentional
Exposure assessment:
not specified
Examinations:
- Other: symptomatic assessment (cough duration and frequency, sputum expellance, sputum nature etc.)

Results and discussion

Clinical signs:
Several patients reported irritation of mucos membranes of pharinx and throat and unpleasant sensation in mouth already after the first inhalations. However, the frequency of such cases was described as minor by the authors. Overall calcium chloride inhalations were said to have beneficiary effects on disease symptoms (improved quality of spatum, decreased amounts of spatum, improved ease of spatum expellance, decreased frequency of coughing).

Applicant's summary and conclusion