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EC number: 247-987-6 | CAS number: 26762-92-5
Skin sensitisation
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:
- 1 994
- 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
- Reference substance name:
- p-menthane hydroperoxide
- IUPAC Name:
- p-menthane hydroperoxide
- 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
Constituent 1
Constituent 2
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.
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