Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
other: medical records
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Secondary source

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
2005
Report date:
2005
Reference Type:
other company data
Title:
Unnamed
Year:
1997
Report date:
2005
Reference Type:
other: medical information
Title:
Unnamed
Year:
1997
Report date:
2005

Materials and methods

Study type:
survey
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3,5,5-trimethylhexanoic acid
EC Number:
221-975-0
EC Name:
3,5,5-trimethylhexanoic acid
Cas Number:
3302-10-1
Molecular formula:
C9H18O2
IUPAC Name:
3,5,5-trimethylhexanoic acid
Details on test material:
Name of substance (as cited): Isononansäure

Method

Type of population:
occupational
Ethical approval:
not specified
Subjects:
no data
Route of administration:
other: unknown, probably inhalation and dermal contact

Results and discussion

Results of examinations:
No cases of sensitisation in workers were observed by company physicians during many years of the production and further processing of the test substance.

Any other information on results incl. tables

According to the Information Network of Departments of Dermatology (Informationsverbund Dermatologischer Kliniken, IVDK) for the surveillance and scientific evaluation of contact allergies in Germany, there are no data on the sensitizing potential of isononanoic acid. On the basis of structure-activity relationships and in view of the fact that isononanoic acid lacks salient structural features typical of allergens, it was deemed unlikely that the chemical has any allergenic potential (IVDK, 1997)

 

The occupational medicine and health care departments of two companies manufacturing and processing isononanoic acid report that after many years of experience, there is no evidence to indicate that the chemical has a sensitizing potential (BASF 1997; Hoechst 1997)

Applicant's summary and conclusion

Conclusions:
Test substance is unlikely to have a sensitizing potential. No cases of sensitisation were apparent during occupational exposure to the test substance.
Executive summary:

No cases of sensitisation in workers were observed by the occupational medicine department of Hoechst AG and BASF AG, two major producers of 3, 5, 5 trimethylhexanoic acid, during many years of production and further processing of the test substance (BASF 1997; Hoechst 1997; cited in BG Chemie, 2005).

Further, the Information Network of Departments of Dermatology for the surveillance and scientific evaluation of contact allergies in Germany, stated that there are no data on the sensitizing potential of isononanoic acid, and deemed it unlikely that the chemical has any allergenic potential (IVDK 1997; cited in BG Chemie, 2005).

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