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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Study predates GLP, human experimental study. Limitations in design and/or reporting but otherwise adequate for assessment

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Acute and repetitive human exposure to isobutane
Author:
Stewart RD, Herrmann AA, Baretta ED, Forster HV, Sikora JJ, Newton PE and Soto RJ
Year:
1977
Bibliographic source:
Scand. J. work. environ. & health 3 234-243
Reference Type:
publication
Title:
Physiological response to aerosol propellants.
Author:
Stewart RD, Newton PE, Baretta ED, Hermann AA, Forster HV, and Soto RJ
Year:
1978
Bibliographic source:
Environ. Health Perspect. 26, 275-285.

Materials and methods

Type of study / information:
Experimental results following human volunteer study
Endpoint addressed:
acute toxicity: inhalation
repeated dose toxicity: inhalation
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Adult volunteers exposed to acute and repeat concentrations of isobutane in a controlled environment chamber.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Isobutane
EC Number:
200-857-2
EC Name:
Isobutane
Cas Number:
75-28-5
Molecular formula:
C4H10
IUPAC Name:
isobutane
Test material form:
gas
Details on test material:
- Name of test material (as cited in study report): isobutane and propane
- Physical state: gas
- Supplied by: Phillips Petroleum Company
Isobutane: boiling point -11.73°C, vapour pressure 3733 mm Hg, vapour density 2.068, SG 0.563
Propane: boiling point -42.49°C, vapour pressure 6612 mm Hg, vapour density 1.549, SG 0.509
Specific details on test material used for the study:
- Name of test material (as cited in study report): isobutane and propane
- Physical state: gas
- Supplied by: Phillips Petroleum Company
Isobutane: boiling point -11.73°C, vapour pressure 3733 mm Hg, vapour density 2.068, SG 0.563
Propane: boiling point -42.49°C, vapour pressure 6612 mm Hg, vapour density 1.549, SG 0.509

Method

Ethical approval:
confirmed and informed consent free of coercion received
Details on study design:
Adult volunteers exposed to isobutane in a controlled environment chamber: Acute exposure of 250-1000 ppm for 1 min, 2 min, 1 hour, 2 hours and 8 hours, repeat exposure at 500 ppm 1, 2 or 8 hours/day, five days/week for 2 weeks. Also acute exposures to isobutane/propane mixtures for 1, 2 or 8 hours/day. All volunteers were kept under comprehensive medical surveillance including cardiac and pulmonary responses (by continuous ECG telemetry and serial computerised spirometric measurements).
Exposure assessment:
measured
Details on exposure:
TYPE OF EXPOSURE: inhalation

TYPE OF EXPOSURE MEASUREMENT: Area air sampling

EXPOSURE LEVELS:
Acute exposure: 250, 500 and 1000 ppm isobutane
Acute exposure: isobutane/propane mix (82.5%/17.5%), propane/isobutane mix (89%/11% and 87.5%/12.5%)
Repeated exposure: 500 ppm isobutane

EXPOSURE PERIOD:
Acute exposure: 1 min, 2 min, 10 min, 1 hour, 2 hour, 8 hour
Acute exposure: isobutane/propane mix 1 hour, 2 hours, 8 hours
Repeated exposure: 1, 2 and 8 hours

Results and discussion

Results:
Acute exposures to isobutane at 250, 500 and 1000 ppm for periods of 1 min to 8 hours did not produce any "untoward physiological effect". Repeat exposures to isobutane at 500 ppm for 1, 2 or 8 hours, 5 days/week for ten exposures and mixtures of isobutane/propane were also without any measurable "untoward physiological effect". 

Any other information on results incl. tables

Analysis of exposure chamber atmospheres: Actual concentrations were within a few per cent of target for each exposure..

Acute exposures: There were no "untoward responses" to the acute exposures.

Repeat exposures to isobutane and isobutane/propane mixtures: There were no untoward subjective responses or abnormal physiological responses during or after these exposures. The following serial laboratory studies were unaltered: complete blood count, urinalysis, serum alkaline phosphatise, SGOT, LDH, serum bilirubin, blood sugar, serum calcium, serum phosphorus, BUN, spontaneous electroencephalogram, visual evoked response, a battery of cognitive tests and an ACTH stimulation test.

During the final week of exposure a reduction in the amplitudes of the 3,4 and 5 waves was observed in the visual evoked response.

Applicant's summary and conclusion

Conclusions:
Acute exposures to isobutane at 250, 500 and 1000 ppm for periods of 1 min to 8 hours did not produce any "untoward physiological effect". Repeat exposures to isobutane at 500 ppm for 1, 2 or 8 hours, 5 days/week for ten exposures and mixtures of isobutane and propane were also without any measurable "untoward physiological effect". 
Executive summary:

Adult volunteers exposed to isobutane in a controlled environment chamber. Acute exposure of 250-1000 ppm (594 -2377 mg/m3 (MW 58.12) ) for 1 min, 2 min, 1 hour, 2 hours and 8 hours. Repeat exposure at 500 ppm 1, 2 or 8 hours/day, five days/week for 2 weeks. Acute exposures to mixtures of isobutane and propane for 1, 2 or 8 hours/day.

During the investigations, all volunteers were kept under comprehensive medical surveillance including cardiac and pulmonary responses (by continuous ECG telemetry and serial computerised spirometric measurements).

Acute exposures to isobutane at 250, 500 and 1000 ppm for periods of 1 min to 8 hours did not produce any "untoward physiological effect". Repeat exposures to isobutane at 500 ppm for 1, 2 or 8 hours, 5 days/week for ten exposures and mixtures of isobutane and propane were also without any measurable "untoward physiological effect".

It was concluded tha the acute NOAEL was > 1000 ppm (2377 mg/m3) and the repeat 2 week exposure NOAEL was > 500 ppm (1189 mg/m3).