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Diss Factsheets

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:
2006
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Toxicity study of the volatile constituents of Myoga utilizing acute dermal irritation assays and the Guinea-Pig Maximization Test
Author:
Qingjun Wei
Year:
2006
Bibliographic source:
Journal of occupational health, 48(6), 480-486 (2006)

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
not specified
Remarks:
publication
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
data from publication

Test material

Constituent 1
Chemical structure
Reference substance name:
Pin-2(3)-ene
EC Number:
201-291-9
EC Name:
Pin-2(3)-ene
Cas Number:
80-56-8
Molecular formula:
C10H16
IUPAC Name:
2,6,6-trimethylbicyclo[3.1.1]hept-2-ene

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
weight: 300-350 g
temperature: 25 oC
humidity: 50-70%

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
DMSO
Concentration / amount:
4%
Day(s)/duration:
7 days
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
DMSO
Concentration / amount:
4%
Day(s)/duration:
14 days
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
DMSO
Concentration / amount:
0.8%
Day(s)/duration:
1 day
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
6
Details on study design:
For induction, 6 intradermal injections of 0.1 ml of compound and Freund's adjuvant were administered in the shaved scapular region. After 7 d, an occluded patch of 0.15 ml of compound was placed on the injection site for 48 h. In the control guinea pigs, the compound was replaced by the solvent. After 14 d, all the guinea pigs (including controls) were exposed to a challenge dose on the shaved flank for 24 h. Skin reactions were observed and scored.
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:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
6
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.8%
No. with + reactions:
0
Total no. in group:
6
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a Guinea-Pig Maximisation Test alpha-pinene was tested for its skin sensitising properties in female Hartley guinea pigs. None of the tested animals showed a positive response after challenge exposure. Therefore it can be concluded that alpha-pinene was not identified as a skin sensitizer in the Guinea-Pig Maximisation Test .
Executive summary:

In a Guinea-Pig Maximisation Test alpha-pinene was tested in female Hartley guinea pigs. None of the tested animals showed a positive response after challenge exposure. Therefore it can be concluded that alpha-pinene was not identified as a skin sensitizer in the Guinea-Pig Maximisation Test .