Registration Dossier
Registration Dossier
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EC number: 279-482-1 | CAS number: 80480-24-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-08-26 / 1994-12-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD Guideline 404 and it is GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5-methyl-2-(1-methylbutyl)-5-propyl-1,3-dioxane
- EC Number:
- 279-482-1
- EC Name:
- 5-methyl-2-(1-methylbutyl)-5-propyl-1,3-dioxane
- Cas Number:
- 80480-24-6
- Molecular formula:
- C13H26O2
- IUPAC Name:
- 5-methyl-2-(1-methylbutyl)-5-propyl-1,3-dioxane
- Details on test material:
- - Physical state: colourless liquid
- Purity test date: >95%
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions: stable under conditions of storage until June 30, 1995.
- Storage: at room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, D-97633 sulzfeld
- Weight at study initiation:2.4-2.7 kg
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): tap water, acidified to pH 3.0, from an automatical wetering system
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19
- Humidity (%): 60
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- The duration of exposure was 4 hours
- Observation period:
- 10 days
- Number of animals:
- 3 females
- Details on study design:
- Hair was clipped on thedorsal area of the trunk one day before the application of the test substance. An electric hair clipper, Aesculap GH 204, with a 1 mm cutterhead was used. The test site was median on the dorsal throcal region.
A cellulose patch with 0.5 mL of the test substance, spread over an area of approximately 6 cm^2, was applied to the test site and held in place by fixing marginally with non irritating tape. The application site was covered by a dressing. Access by the animal to the application site was prevented by a plastic collar.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible
Any other information on results incl. tables
| Time after the end of exposure | Erythema / Eschar | Oedema | ||||
| Animal 1 | Animal 2 | Animal 3 | Animal 1 | Animal 2 | Animal 3 | |
| 1h | 2 | 2 | 3 | 3 | 2 | 4 |
| 24h | 1 | 2 | 3 | 1 | 1 | 3 |
| 48h | 1 | 2 | 2 | 0 | 1 | 1 |
| 72h | 0 | 2 | 2 | 0 | 1 | 0 |
| Mean (24 -72h) | 0.7 | 2 | 2.3 | 0.3 | 1 | 1.3 |
| 6d | - | 2 | 1 | - | 1 | 0 |
| 8d | - | 1 | 1 | - | 0 | 0 |
| 10d | - | 0 | 0 | - | 0 | 0 |
- no further examinations
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is considered not irritant according with the CLP criteria.
- Executive summary:
The test substance was applied to the intact skin of each of 3 rabbits.
The animals were examined for local reactions and for general signs.
Methods and investigations were performed in conformance with the OECD Guideline 404 and the EU method B.4.
General toxic effects: no general toxic effects of the test substance were observed.
Mean scores for erythema/eschar formation, c indicate no irritation to skin.
Scores returned to "0", i.e. normal, within maximum 10 days after patch removal in all animals.
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