Registration Dossier
Registration Dossier
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EC number: 262-475-2 | CAS number: 60857-05-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Tetrahydro-4-methylene-2-(2-methyl-1-propenyl)-2H-pyran
- EC Number:
- 262-475-2
- EC Name:
- Tetrahydro-4-methylene-2-(2-methyl-1-propenyl)-2H-pyran
- Cas Number:
- 60857-05-8
- Molecular formula:
- C10H16O
- IUPAC Name:
- 4-methylidene-2-(2-methylprop-1-en-1-yl)oxane
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Age on day 0: 5 - 8 weeks
Acclimatization period 15 days before the first test substance application.
Identification via ear tattoo.
Body weight (day 0): 383 - 431 g
The animals were housed in fully air-conditioned rooms with a room temperature ranging between 20 - 24°C and a relative humidity in the range of 30 - 70%. The day/night rhythm was 12 h dark and 12 h light. Five guinea pigs per cage (plastic cages, type 3020W009 with perforated base (floor area: 4000 cm2). Wooden gnawing blocks were used.
A standardized animal laboratory diet as well as tap water were available ad libitum.
- Source: Charles River Laboratories (Germany)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Pretest: 50% in peanut oil PH.EUR. 5.5; undiluted
Main test induction: undiluted
Main test challenge: undiluted
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Pretest: 50% in peanut oil PH.EUR. 5.5; undiluted
Main test induction: undiluted
Main test challenge: undiluted
- No. of animals per dose:
- Pretest: 3 (per concentration tested)
Main test:
20 (test group)
10 (control group) - Details on study design:
- RANGE FINDING TESTS:
0.5 ml test substance (undiluted, 50% in peanut oil PH.EUR. 5.5) was topically applied (occlusive) for 6 hours. Readings: 1, 24 and 48 h after removal of the patch.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6h
- Control group: not treated
- Site: Intact flank
- Frequency of applications: days 0, 7 and 14
- Concentrations: undiluted
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 14 days after the third induction
- Exposure period: 6 hours
- Control group: treated as test group
- Site: Intact flank
- Concentrations: undiluted
- Evaluation (hr after challenge): 24 and 48 h after the removal of the patch - Challenge controls:
- yes (not treated during induction period)
- Positive control substance(s):
- yes
- Remarks:
- A positive control is not included in this study. However, a separate study is performed twice a year to proove that the laboratory is able to detect sensitizing compounds under the laboratory conditions chosen.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- 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: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Pretest:
After application of a 50% test-substance preparation as well as of the undiluted test substance, no skin irritation could be observed.
Main test:
The inductions with the undiluted test substance did not cause any skin reactions in all test group animals.
The challenge with the undiluted test substance did not cause any skin reactions neither in animals of the control group nor in test group animals 24 and 48 hours after removal of the patch.
The expected body weight gain was generally observed in the course of the study.
Applicant's summary and conclusion
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