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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:
2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well performed study with deviations: no information on age and housing conditions of animals; details on patch material, nature and degree of toxicity, grading system not mentioned
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2003

Materials and methods

Principles of method if other than guideline:
The cumulative contact enhancement test (Tsuchiya et al. 1985)
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
Litterature data allow us to classify delta-3-carene as skin sensitiser and the method applied is a non-LLNA method.

Test material

Constituent 1
Chemical structure
Reference substance name:
3,7,7-trimethylbicyclo[4.1.0]hept-3-ene
EC Number:
236-719-3
EC Name:
3,7,7-trimethylbicyclo[4.1.0]hept-3-ene
Cas Number:
13466-78-9
Molecular formula:
C10H16
IUPAC Name:
3,7,7-trimethylbicyclo[4.1.0]hept-3-ene
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 250-300 g

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
0%
Day(s)/duration:
10
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
1%
Day(s)/duration:
10
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
3%
Day(s)/duration:
10
Route:
epicutaneous, occlusive
Vehicle:
olive oil
Concentration / amount:
10%
Day(s)/duration:
10
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Concentration / amount:
0%
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Concentration / amount:
1%
No.:
#3
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Concentration / amount:
3%
No.:
#4
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Remarks:
and arachis oil
Concentration / amount:
10%
No. of animals per dose:
12 or 10
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Four
- Exposure period: 24 hours
- Control group: Vehicle only, olive oil
- Site: Scapular region
- Duration: 10 days with an intradermal injection of Freuds complete adjuvant at the third event followed by an open skin test on day 21.
- Concentrations: 50%

B. CHALLENGE EXPOSURE
- Control group: Vehicle only, arachis oil
- Site: Shaven Flanks
- Concentrations: 10, 3 and 1%


Challenge controls:
10 challenge controls
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
0
Group:
test chemical
Dose level:
1%
No. with + reactions:
8
Total no. in group:
12
Clinical observations:
Minimum criterion for positive reaction: erythema
Key result
Reading:
1st reading
Hours after challenge:
0
Group:
test chemical
Dose level:
3%
No. with + reactions:
8
Total no. in group:
12
Clinical observations:
Minimum criterion for positive reaction: erythema
Key result
Reading:
1st reading
Hours after challenge:
0
Group:
test chemical
Dose level:
10%
No. with + reactions:
8
Total no. in group:
12
Clinical observations:
Minimum criterion for positive reaction: erythema
Key result
Reading:
2nd reading
Hours after challenge:
0
Group:
test chemical
Dose level:
1%
No. with + reactions:
7
Total no. in group:
10
Clinical observations:
Minimum criterion for positive reaction: erythema
Key result
Reading:
2nd reading
Hours after challenge:
0
Group:
test chemical
Dose level:
3%
No. with + reactions:
7
Total no. in group:
10
Clinical observations:
Minimum criterion for positive reaction: erythema
Key result
Reading:
2nd reading
Hours after challenge:
0
Group:
test chemical
Dose level:
10%
No. with + reactions:
7
Total no. in group:
10
Clinical observations:
Minimum criterion for positive reaction: erythema
Reading:
other: not measured/tested
Hours after challenge:
0
Group:
negative control
Dose level:
None
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
None
Remarks on result:
not measured/tested
Reading:
other: not measured/tested
Hours after challenge:
0
Group:
positive control
Dose level:
None
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
None
Remarks on result:
not measured/tested

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Remarks:
Migrated information
Conclusions:
delta-3-Carene was found to be a skin sensitiser.
Executive summary:

delta-3 -Carene was tested for skin sensitisation in female Dunkin-Hartley guinea pigs. Groups of guinea pigs (10 or 12/group) received four occluded dermal exposure for 24 hours in scapular region of 50% delta-3-carene followed by challenge dose on the shaven flanks with 10, 3, 1% and vehicle.

 

In the first set of experiments 8 out of 12 and in second, 7 out of 10 animals showed presence of erythema which was considered as positive reaction.

Therefore, delta-3-carene was found to be a skin sensitiser.