Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific principles, acceptable for assessment but without detailed documentations

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Further studies on sensory response to certain industrial solvent vapors
Author:
Silverman L, Schulte HF, First MW
Year:
1946
Bibliographic source:
J Ind Hyg Toxicol., 28: 262-266
Reference Type:
publication
Title:
Sensory Response to Certain Industrial Solvent Vapor
Author:
Nelson KW, Ege JF, Ross M, Woodman LE and Silverman L
Year:
1943
Bibliographic source:
J Ind Hyg Toxicol., 25, 282-285

Materials and methods

Endpoint addressed:
eye irritation
respiratory irritation
Principles of method if other than guideline:
Exposure of 12 male and 12 female test persons to methyl isobutyl carbinol vapour in a concentration of 50 ppm (approximates the saturation concentration at 25°C) for 15 minutes.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-methylpentan-2-ol
EC Number:
203-551-7
EC Name:
4-methylpentan-2-ol
Cas Number:
108-11-2
Molecular formula:
C6H14O
IUPAC Name:
4-methylpentan-2-ol
Details on test material:
Technical grade solvent supplied by the Shell Development Company, Emeryville, California

Method

Ethical approval:
not specified
Exposure assessment:
not specified
Details on exposure:
The experimental procedure was similar to that described by Nelson et al., (1943). An average number of twelve subjects of both sexes were used for each solvent exposure. The procedure used previously was modified as follows: 1) The time of exposure was increased to fifteen minutes. This period permitted more accurate observation of olfactory fatigue and a better appraisal of increasing or decreasing irritation of mucous membranes. 2) During the 15 minute exposure period, motion pictures were shown te occupy the subjects' attention and divert their thoughts from the atmospheric contamination to which they were expose.

Results and discussion

Results:
A majority of subjects found MIBC irritating to the eyes at 50 ppm with nose and throat irritation experienced at higher concentrations.The odor was not objectionable at this concentration.

Any other information on results incl. tables

SENSORY LIMITS OBTAINED ON SOLVENT VAPORS

Solvent

Highest concentration which majority of subjects estimated satisfactory for 8-hour exposure

ppm

Concentrationofvapour which irritated majority of subjects

Suggested maximum allowable concentrations

ppm

Eyes

ppm

Nose

ppm

Throat

ppm

Methyl isobutyl carcinol

25

50

>50

>50

None

Applicant's summary and conclusion

Executive summary:

A study with human volunteers (12/sex) indicated that vapor exposure to MIBC at 50 ppm for 15 minutes resulted in eye irritation in most subjects with nose and throat irritation experienced at higher concentrations. The maximum tolerable concentration was considered to be 25 ppm.