Registration Dossier

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:
other information
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication, but of limited relevance for information requirements

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Type of study / information:
olfactory sensation/odour threshold test
Principles of method if other than guideline:
no guideline required
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): tri-n-butylamine
- Analytical purity: > 99.5%

Method

Ethical approval:
not specified
Details on study design:
8 female and 8 male volunteers (randomly selected from 46 volunteers) were exposed to the test substance in 6 varying concentrations (not stated in detail) and to blank samples to determine an odour threshold. Therefore, a single entry of 6 sec was performed and not exhaled until they had withdrawn
Exposure assessment:
measured

Results and discussion

Results:
An odour threshold (100% recognition) of 0.07 +/- 0.03 ppm (approx. 0.54 mg/m3) was identified in this study (lowest value: 0.01 ppm).

Applicant's summary and conclusion

Conclusions:
No conclusions can be drawn with respect to information requirements.
Executive summary:

8 female and 8 male volunteers were exposed to the test substance (> 99.5% pure) in varying concentrations. An odour threshold of 0.07 +/- 0.03 ppm (approx. 0.54 mg/m3) was identified in this study (lowest value: 0.01 ppm) (Laing et al., 1987).