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Registration Dossier
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EC number: 240-457-5 | CAS number: 16409-43-1
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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study was performed before LLNA was formally validated and available as OECD guideline in 2002.
Test material
- Reference substance name:
- Tetrahydro-4-methyl-2-(2-methylprop-1-enyl)pyran
- EC Number:
- 240-457-5
- EC Name:
- Tetrahydro-4-methyl-2-(2-methylprop-1-enyl)pyran
- Cas Number:
- 16409-43-1
- Molecular formula:
- C10H18O
- IUPAC Name:
- tetrahydro-4-methyl-2-(2-methylprop-1-enyl)pyran
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley, lnc.
- Weight at study initiation: 344-532 g
- housing: individually
- Acclimation period: at least 4 days
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: diethyl phthalate (DEP)
- Concentration / amount:
- 50% for induction
0.5%, 1.5% and 5% for challenge
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: diethyl phthalate (DEP)
- Concentration / amount:
- 50% for induction
0.5%, 1.5% and 5% for challenge
- No. of animals per dose:
- 20 (10/sex) for treated group
10 (5/sex) for control group - Details on study design:
- RANGE FINDING TESTS:
Irritation was evaluated before a delayed hypersensitivity study in guinea pigs. A 0.3 ml aliquot of tetrahydro-4-methyl-2-(2-methylpropen-1-yl)pyran at concentrations of 0.5%, 1%, 2.5%, 5%, 10%, 25% and 50% in diethyl phthalate and undiluted substance were applied to the clipped back for 6 hours under occlusion using 25 mm Hill Top Chambers®. Reactions were scored 24 and 48h after application. 4 animals per sex were tested.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Site: shoulder
- Frequency of applications: once a week
- Duration: 3 weeks
- Concentrations: 50%
- Control group: not treated
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: approx. 2 weeks after last induction
- Site: untreated shoulder
- Concentrations: 0.5%, 1.5% and 5%
- Evaluation (hr after challenge): approx. 24 hours and 48 hours - Positive control substance(s):
- yes
- Remarks:
- Historical positive control data generated February 20 and 21 1992 using 1-Chloro-2,4-Dinitrobenzene (DNCB)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- +/- reactions were observed in 1 animal
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: +/- reactions were observed in 1 animal.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1.5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- +/- reactions were observed in 2 animals
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1.5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: +/- reactions were observed in 2 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
Any other information on results incl. tables
Results Range Finding Test:
Slight or patchy erythema (score +/-) was found at all concentrations tested.
Slight or patchy erythema (score +/-) at time point 24h and 48h was found at 2.5% test substance and higher concentrations.
Slight or patchy erythema (score +/-) at time point 24h and 48h in 3/4 animals was found at 10%, 25% and 50% test substance.
Grade 1 erythema was observed in 1/4 animals at 50% test substance.
Undiluted material produced grade 1 erythema in 3/4 animals.
Challenge controls:
Slight or patchy erythema (score +/-) was found at time point 24h in 1/10 animals at 5% test substance.
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