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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Acceptable study methodology prior to LLNA acceptance.

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(tricyclo[5.2.1.02,6]dec-8-ylidene)butyraldehyde
EC Number:
250-078-7
EC Name:
4-(tricyclo[5.2.1.02,6]dec-8-ylidene)butyraldehyde
Cas Number:
30168-23-1
Molecular formula:
C14H20O
IUPAC Name:
4-[(8Z)-tricyclo[5.2.1.0^{2,6}]decan-8-ylidene]butanal
Test material form:
liquid
Specific details on test material used for the study:
Dupical: T-05481, An.nr.123001, no.146398.
A clear yellow fragrance material.

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Albino SPF
Sex:
male
Details on test animals and environmental conditions:
Acclimatisation: 3 days.
Individually house in suspended stainless steel cages fitted with wire mesh floors and fronts.
Temperature: 23 +/- 1'C.
Relative humidity: 50 +10%.
12 hour light and dark cycle.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: Freund's Complete Adjuvant
Concentration / amount:
0%
Day(s)/duration:
24 hours
Route:
intradermal
Vehicle:
propylene glycol
Concentration / amount:
50%
Day(s)/duration:
24 hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
intradermal
Vehicle:
other: Propylene glycol and Freund's Complete Adjuvant (FCA) (1:1)
Concentration / amount:
50%
Day(s)/duration:
24 hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
other: topical
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
48 hours
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
15%
Day(s)/duration:
24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Control: 5 animals.
Dose: 10 animals per dose.
Details on study design:
Preliminary test:
The intradermal and topical irritancy of a range of dilutions of the test substance were examined.
The maximum concentration suitable for intradermal injection was fouond to be 50% v/v in water, and for topical application 30% w/w in vaseline.
These conditions were used in the main test.

Main test:
Induction was effected in a two-stage operation consisting of firstly, a number of intradermal injections made simultaneously and, secondly, one week later, a closed patch exposure performed over the injection sites.
Three pairs of intradermal injections were made in the clipped area.
After one week, the same area of the skin was close shaved again and topically treated with a 30% dilution of the test substance in vaseline. The patch was covered with PVC foil.
The dressing was left for 48 hours and skin readings were made after removal of the patches.

Challenge procedure:
Animals were challenged two weeks after thye topical induction.
The same area of the skin was close shaved again and topically treated with a 10% dilution of the test substance in vaseline.The patch was covered with PVC foil.
The dressing was left for 24 hours and skin readings were made after removal of the patches at 0, 24 and 48 hours.
Challenge controls:
The animals were challenged at day 14 after the topical induction.
Dupical was mixed in vaseline.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
5
Total no. in group:
10
Clinical observations:
Erythema
Remarks on result:
not determinable because of methodological limitations
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
1
Total no. in group:
5
Clinical observations:
Erythema
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the experiment Dupical indicated a possible potential for weak sensitisation according to the classification of Magnusson and Kilgman (1970) but study is insufficient in severity or in length of time that signs were observed.