Registration Dossier
Registration Dossier
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EC number: 216-074-4 | CAS number: 1490-04-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well documented and scientifically acceptabl
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
- Principles of method if other than guideline:
- The sensitisation potential of a test material, HR 90/000102, was investigated by means of the Buehler Test for sensitisation in guinea pigs.
Following dose ranging a concentration of 25% w/v in ethanol:DEP was selected for induction and challenge. - GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- DL-menthol
- EC Number:
- 216-074-4
- EC Name:
- DL-menthol
- Cas Number:
- 1490-04-6
- Molecular formula:
- C10H20O
- IUPAC Name:
- 2-isopropyl-5-methylcyclohexanol
- Details on test material:
- test substance: l-menthol (HR 90/000102)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 25% wv in ethanol:diethylphthalate
- Concentration / amount:
- 25 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 25% wv in ethanol:diethylphthalate
- Concentration / amount:
- 25 %
- No. of animals per dose:
- test grup: 20 guine pigs
control group: 20 guinea pigs
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% in ethanol:DEP (vehicle)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% in ethanol:DEP (vehicle). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- ethanol:DEP (vehicle)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: ethanol:DEP (vehicle). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% in ethanol:DEP (vehicle)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% in ethanol:DEP (vehicle). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- ethanol:DEP (vehicle)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: ethanol:DEP (vehicle). No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Induction
No irritation was noted in any of the test group animals in Weeks 1, 2 or 3 of induction.
No irritation was noted in the control group animals at any time during induction.
Challenge
No positive responses were noted in any of the animals in the test group or the control group after challenge
with HR 90/000102 at a concentration of 25% w/v in ethanol :DEP.
There were no reactions to challenge with the vehicle in the test or control groups.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Executive summary:
The sensitisation potential of a test material, HR 90/000102, was investigated by means of the Buehler Test for sensitisation in guinea
pigs.
Following dose ranging a concentration of 25% w/v in ethanol:DEP was selected for induction and challenge.
At challenge, none of the test and control group animals treated with HR 90/000102 at a concentration of 25% w/v in ethanol:DEP showed a positive response.
There is no evidence from the test results that HR 90/000102 is a sensitiser in guinea pigs.
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