Registration Dossier
Registration Dossier
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EC number: 221-975-0 | CAS number: 3302-10-1
Sensitisation data (human)
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:
- 2 005
- Report date:
- 2005
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 2005
- Reference Type:
- other: medical information
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 2005
Materials and methods
- Study type:
- survey
- GLP compliance:
- no
Test material
- 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
Constituent 1
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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