Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1965

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Determination of the concentration inhalated which induced eye, nose and throat irritation and odour detection.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclopentanone
EC Number:
204-435-9
EC Name:
Cyclopentanone
Cas Number:
120-92-3
Molecular formula:
C5H8O
IUPAC Name:
cyclopentanone
Details on test material:
From Esso reseach and Engineering Company. No more data

Method

Ethical approval:
not specified
Details on study design:
no data
Exposure assessment:
not specified
Details on exposure:
Six human volunteers were used. At the beginning of the study, subjects were exposed to methyl isobutenyl ketone to familiarize themselves with their responsabilities during the testing procedure and to establish optimum exposure conditions.

Week 1 consisted of exposure to several concentrations of a documented ketone similar to those being tested.

Week 2 consisted of exposure (first exposure series) of each test group to one of the test compounds at increasing concentrations until sensory irritation threshold were established.

Week 4 consisted of a confirmatory exposure (second exposure series) of six subjects to the test substance, first at the concentration established as the sensory irritation threshold and then at additional concentrations, if that seemed necessary.
Subject breath air only through his nose with or without test substance from the aerosol chamber via a mask.
At the beginning of each series, pure air was passed through the aerosol chamber (volume of 125 L) and, at some time during the series, the substance was introduced into the air supply at a predetermined concentration for a period of 7 minutes.
After each series, aerosol generator calibrated was weighted and the concentration of the substance per litre of air accurately determined. Concentration was reported as weight of substance (mg) per unit volume (L) of airflow.

Results and discussion

Results:
Throat irritation was observed at a level of 0.518 mg/L of air which corresponded to approximately 150 ppm expressed as a vapour concentration.
Eye and nasal irritation was observed at a concentration of 1.337 mg/L of air (to approximately 390 ppm expressed as a vapour concentration).
The odour detection concentration was below 0.158 mg/L (to approximately 50 ppm expressed as a vapour concentration).
No significant difference was noted in sensory irritation response between the initial and the second exposure series to the test substance.

Applicant's summary and conclusion