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Administrative data

Description of key information

3,5,5 -trimethylhexanoic acid did not induce skin sensitisation in a guinea-pig maximisation test. No cases of skin sensitisation have been observed in two large companies producing 3,5,5 -trimethylhexanoic acid and no cases are reported in the literature.

There is no information available on respiratory sensitising effects of 3,5,5 -trimethylhexanoic acid.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
guinea pig maximisation test, unclear if according to guidelines
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study has been performed before REACH regulation came into force
Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
no details provided
Route:
intradermal
Vehicle:
not specified
Concentration / amount:
1-5%
Day(s)/duration:
no data
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
not provided
Day(s)/duration:
no data
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
no data
Day(s)/duration:
24 h
Adequacy of challenge:
not specified
No. of animals per dose:
20-25
Details on study design:
no data
Challenge controls:
no data
Positive control substance(s):
not specified
Positive control results:
Positive results have been shown for several substances, e.g. acrylic monomere or potassium dichromate
Key result
Reading:
other: overall result
Group:
test chemical
Dose level:
pure substance
Clinical observations:
no data provided
Remarks on result:
no indication of skin sensitisation
Remarks:
no further information provided
Reading:
other: overall result
Group:
negative control
Dose level:
not indicated
Clinical observations:
no data provided
Remarks on result:
no indication of skin sensitisation
Reading:
other: overall result
Group:
positive control
Dose level:
<=25%
Clinical observations:
no data provided
Remarks on result:
positive indication of skin sensitisation

Result: negative (no further details provided)

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was reported to be not sensitising in this study.
Executive summary:

The test substance was not sensitising in a guinea pig maximisation test (no details reported) (Cronin, 1994).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In vitro data:

Skin sensitisation in vitro has not been investigated as there is sufficient information available for the submission substance.

Animal data:

3,5,5-trimethylhexanoic acid did not induce skin sensitisation in a guinea pig maximisation test. This assay has been performed according to a generally accepted methodology. No indication for skin sensitisation was obtained. This negative result is supported by the findings of the OECD Toolbox profiler which did not indicate an alert for skin sensitising properties.

Human experience (chapter 7.10.4):

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).

Overall, 3, 5, 5-trimethylhexanoic acid is not likely to have sensitizing properties.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the negative findings in a guinea-pig maximisation test and the experience with 3,5,5 -trimethylhexanoic acid from the workplace it is concluded that the submission substance 3,5,5-trimethylhexanoic acid does not cause skin sensitisation and has not to be classified as skin sensitiser according to Regulation (EC) No 1272/2008.

There is no information available on respiratory sensitising effects of 3,5,5 -trimethylhexanoic acid.

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