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Toxicological information

Skin sensitisation

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Administrative data

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

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1994
Report date:
1994
Reference Type:
publication
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Test guideline
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

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
Test material form:
liquid
Details on test material:
Name of test material (as cited in study report): 3,5,5-trimethylhexanoic acid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
no details provided

Study design: in vivo (non-LLNA)

Inductionopen allclose all
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
Challenge
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

Results and discussion

Positive control results:
Positive results have been shown for several substances, e.g. acrylic monomere or potassium dichromate

In vivo (non-LLNA)

Resultsopen allclose all
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

Any other information on results incl. tables

Result: negative (no further details provided)

Applicant's summary and conclusion

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).