Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
