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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:
key study
Study period:
15/05 to 30/06 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study conform guidelines under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
study already available

Test material

Constituent 1
Reference substance name:
p-menthane hydroperoxide
IUPAC Name:
p-menthane hydroperoxide
Constituent 2
Chemical structure
Reference substance name:
Menthane, monohydroperoxy derivative
EC Number:
247-987-6
EC Name:
Menthane, monohydroperoxy derivative
Cas Number:
26762-92-5
Molecular formula:
C10H20O2
IUPAC Name:
menthane, monohydroperoxy derivative
Details on test material:
- Name of test material (as cited in study report): p-menthane hydroperoxide
- Physical state: liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, 33176 Borchen
- Age at study initiation: young adults
- Weight at study initiation: < 500 g
- Housing: 5 animals/macrolon IV cage
- Diet: Ssniff standard laboratory guinea pig feed ad libitum
- Water: ad libitum
- Acclimation period: > 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70%
- Air changes (per hr):15/hr
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 15-05-1994 To: 30-06-1994

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
epicutaneous induction I : 50%
epicutaneous induction II : 50%
epicutaneous induction III : 25% (in view of severe skin damage observed during first and sceond induction)

epicutaneous challenge: 5%

all concentrations based on pre-tests to set irritant properties
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
epicutaneous induction I : 50%
epicutaneous induction II : 50%
epicutaneous induction III : 25% (in view of severe skin damage observed during first and sceond induction)

epicutaneous challenge: 5%

all concentrations based on pre-tests to set irritant properties
No. of animals per dose:
20 in test group and 10 controls
Details on study design:
application volume 0.4 cm3 on 4 cm2

RANGE FINDING TESTS: PIT indicating 5% as non-irritant and 50% as irritant dose

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 anaimals
- Site: 2X2 cm on flank
- Frequency of applications: induction on day 0, 7,and 14
- Concentrations: 50% first two inductions, 25% last induction

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: 2X2 cm on flank
- Concentrations: 5%
- Evaluation (hr after challenge): 30 and 54 hours

Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazol

Results and discussion

Positive control results:
positive in 10/10 animals at 50%

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
30
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 30.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
30
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 30.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
54
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
54
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a Buehler test the test substance did not induce sensitisation in guinea pigs.
Executive summary:

In a Buehler test in guinea pigs performed in agreement with the protocol as described in OECD 406, severe irritation (erythema and oedema with scales and callus formation) was observed after epicutaneous induction. Challenge with 5% of the test substance did not induce any skin reaction. It is concluded that the test substance does not induce sensitisation.