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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:
weight of evidence
Study period:
1943
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
Data old but key scientific details recorded. There is no information provided on how vapour concentrations were determined. However, when used in addition to animal data (Saunders et al., 2013; see "specific investigations: other studies"), regarded as sufficient to classify cyclohexanone as irritating to the respiratory tract.

Data source

Reference
Reference Type:
publication
Title:
Sensory response to certain industrial solvent vapours
Author:
Nelson, K. W. et al.
Year:
1943
Bibliographic source:
J. Ind. Hyg. Toxicol. 25, 282-285

Materials and methods

Type of study / information:
Human sensory irritation
Endpoint addressed:
eye irritation
respiratory irritation
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Study to evaluate the discomfortable sensory response but not necessarily toxic effects that result from exposure to solvent vapours.
GLP compliance:
no
Remarks:
study pre-dates GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclohexanone
EC Number:
203-631-1
EC Name:
Cyclohexanone
Cas Number:
108-94-1
Molecular formula:
C6H10O
IUPAC Name:
cyclohexanone
Details on test material:
Name of test material (as cited in study report): cyclohexanone
Analytical purity: pure

Method

Ethical approval:
not specified
Details on study design:
human volunteer study
Details on exposure:
TYPE OF EXPOSURE: Whole body exposure in a 1200 cu foot gas cabinet. Vapour concentrations produced by adding a stream of saturated vapour to the measured air being blown into the chamber.

TYPE OF EXPOSURE MEASUREMENT: no clear data. May be by estimation based on mass flow into cabinet.

EXPOSURE LEVELS: Not explicitly specified; but exposures at 25 ppm, 50 ppm and 75 ppm mentioned.

EXPOSURE PERIOD: 3-5 mins

NUMBER OF HUMAN VOLUNTEERS EXPOSED: average number of persons exposed: 10 (males and females)

Results and discussion

Results:
At 75 ppm, the majority of subjects experienced some degree of irritation (discomfort) to the eyes, nose and throat. Also a concentration of 50 ppm was not tolerated (irritation to the throat being the most marked effect). 25 ppm was not objectionable to most subjects. The majority of volunteers indicted that an exposure to 25 ppm would be tolerable over an extended (8 hour) period.

Applicant's summary and conclusion

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