Registration Dossier
Registration Dossier
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EC number: 240-457-5 | CAS number: 16409-43-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Experimental Toxicology and Ecology, BASF AG, Ludwigshafen, Germany
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
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S. A., 01540 Vonnas, France
- Age at study initiation: 6 - 7 months
- Weight at study initiation: 3.62 - 4.16 kg
- Housing: single
- Diet: Kliba-Labordiaet about 130 g/animal per day
- Water: tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipping of fur
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48, 72 hours and on day 7, day 14
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: patch of 2.5 cm x 2.5 cm moisted with 0.5 ml undiluted test substance
- Type of wrap if used: The test substance was covered with a test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull® stretch (adhesive fleece), Beiersdorf AG
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 h
SCORING SYSTEM: according to guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 3.1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d (2 animals); 14d (1 animal)
Any other information on results incl. tables
Individual cutaneous examination and mean values:
|
|
Exposure period: 4h |
||
Animal |
Erythema |
Edema |
Additional findings |
|
0h |
01 |
2 |
2 |
15, 16 |
02 |
2 |
2 |
15, 16 |
|
03 |
2 |
2 |
15, 16 |
|
1h |
01 |
3 |
2 |
15, 16 |
02 |
3 |
2 |
15, 16 |
|
03 |
3 |
2 |
15, 16 |
|
24h |
01 |
3 |
1 |
15, 16 |
02 |
3 |
1 |
15, 16 |
|
03 |
3 |
1 |
15, 16 |
|
48h |
01 |
3 |
1 |
15, 16, 24 |
02 |
3 |
1 |
15, 16, 24 |
|
03 |
3 |
1 |
15, 16, 24 |
|
72h |
01 |
3 |
1 |
15, 16, 24 |
02 |
3 |
1 |
15, 16, 24 |
|
03 |
4 |
1 |
15, 16, 24 |
|
7d |
01 |
2 |
0 |
SS, 15, 18 |
02 |
3 |
1 |
SS, 15, 16, 18, 24 |
|
03 |
3 |
0 |
SS, 15, 18, 24 |
|
14d |
01 |
2 |
0 |
S, 15, 24 |
02 |
1 |
0 |
S, 15 |
|
03 |
2 |
0 |
15 |
|
Mean 24-72h |
01 |
3.0 |
1.0 |
|
02 |
3.0 |
1.0 |
|
|
03 |
3.3 |
1.0 |
|
|
Mean |
|
3.1 |
1.0 |
|
15 = erythema extending beyond the area of exposure
16 = edema extending beyond the area of exposure
18 = severe scaling extending beyond the area of exposure
24 = petechiae
S = scaling
SS = severe scaling
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.
