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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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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: Study adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
eye irritation
respiratory irritation
Principles of method if other than guideline:
The study assessed daily, both objectively and/or subjectively, the ocular and respiratory irritation experienced by the same 12 subjects.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Glutaral
EC Number:
203-856-5
EC Name:
Glutaral
Cas Number:
111-30-8
Molecular formula:
C5H8O2
IUPAC Name:
glutaraldehyde
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Cidex activated dialdehyde solution & Sporicidin cold sterilizing solution.
- Composition of test material, percentage of components: unknown. active ingredient ca 2%

Method

Type of population:
general
Subjects:
A panel of 12 subjects, 9 females and 3 males, started and completed the study
Ethical approval:
confirmed and informed consent free of coercion received
Route of exposure:
inhalation
ocular
Reason of exposure:
intentional
Exposure assessment:
not specified
Details on exposure:
The test panel was placed in a closed room and were exposed to an individual test substance each day. A different test solution was used on each of the five exposure days. Containers with the test material were placed in the room at 2 or more locations and were agitated and in total 8 hours of exposure took place.
Examinations:
To asses if any effects occured in between test days (minimum of 48 hrs) a questionaire including eye and respiratory irritaion questions was executed prior to each test day. The questionaire was followed by an occular examination. When irritation developed during exposure the subject was removed and interviewed. All subjects were screened and examined prior and at the end of the 8 hour exposure period.

Results and discussion

Results of examinations:
Cidex: The panel was exposed to Cidex on the first two exposure days. On the first exposure day 1/12 reported dryness of nose, 1/12 dryness of throat, 2/12 burning of eyes, 2/12 itching of eyes, 1/12 watery eyes and 10/12 detected odor. On the second exposure day 1/12 reported irritation of the nose, 1/12 burning of eyes, 1/12 stinging of eyes, 1/12 itching of eyes, 1/12 watery eyes and 11/12 detected odor.

Sporicidin: The panel was exposed to Sporicidin on the last exposure day (fifth). 1/12 reported watery eyes and 11/12 detected odor. No other effects were reported.

For both test materials, lachrymation, palpebral conjuctiva redness, and bulbar conjunctiva redness were not observed.

Applicant's summary and conclusion