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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other: safety evaluation
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: secondary source

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Principles of method if other than guideline:
Estimation of per capita exposure against flavoring substances in the U.S. and in Europe

Test material

Constituent 1
Chemical structure
Reference substance name:
3,5,5-trimethylhexan-1-ol
EC Number:
222-376-7
EC Name:
3,5,5-trimethylhexan-1-ol
Cas Number:
3452-97-9
Molecular formula:
C9H20O
IUPAC Name:
3,5,5-trimethylhexan-1-ol

Results and discussion

Any other information on results incl. tables

Estimates of the per capita intake:

Compound

Estimated in take

(µg/person/day)

Intake

Threshold

(µg/person/day)

USA

EuropeC

3,5,5-trimethylhexan-1-ol

0.76

13

1800

3,5,5-trimethylhexanal

150

0.29

180

The estimated intake is far below the intake threshold, and it was concluded that there is no safety concern (Semino, 1998)

Applicant's summary and conclusion

Conclusions:
The use of isononanol, and also of isononanal, as flavoring substances results in a daily intake in the USA and in Europe which is far below the threshold. Therefore there were no safety concerns seen (WHO, 1998).
Executive summary:

The estimated intake of isononanol, and also of isononanal, resulting from the use as flavoring substances, is far below the intake threshold, and it was therefore concluded that there is no safety concern (Semino, 1998).