Registration Dossier
Registration Dossier
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EC number: 234-294-9 | CAS number: 11071-47-9
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: According to guideline study (OECD 404)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Dodecene, branched
- EC Number:
- 306-479-5
- EC Name:
- Dodecene, branched
- Cas Number:
- 97280-83-6
- Molecular formula:
- C12 H24
- IUPAC Name:
- Dodecene, reaction product of butene
- Details on test material:
- - Name of test material (as cited in study report): Isododecene
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, 6050 Offenbach/Main, FRG
- Age at study initiation:
- Weight at study initiation: Animal 1 (female) - 2.97 kg ; Animal 2 (male) - 3.31 kg ; Animal 3 (male) - 3.02 kg
- Housing: 1 animal per cage; in cages made of stainless steel with wire mesh walk floors (without bedding)
- Diet (e.g. ad libitum): about 130 g per animal per day (KLIBA 341)
- Water (e.g. ad libitum): about 250 ml tap water per animal per day
- Acclimation period: at least 8 days (same housing conditions as during the study)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12
There were no deviations from these ranges which influenced the results of the study.
Animal identification: Ear tattoo
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 15 days
- Number of animals:
- 3 (2 males and 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: four layers of absorbent gauze + porous bandage
Clipping of the fur: at least 15 hours before the beginning of the study. Test substance was applied on the test patch which was then applied to the skin.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lutrol and lutrol/water (1:1)
- Time after start of exposure: at the end of the exposure period
SCORING SYSTEM: Draize score
Readings: 30 - 60 minutes after removal of the test patches and 24 h, 48 h, 72 h, 8 d and 15 d after the beginning of application
(For calculation of the means of erythema and edema only the readings of 24, 48 and 72 hours are used)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 hours
- Score:
- 2.7
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 hours
- Score:
- 3
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 hours
- Score:
- 3.3
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 3
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 hours
- Score:
- 2.3
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 hours
- Score:
- 3
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 hours
- Score:
- 0.7
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 2
Any other information on results incl. tables
| Animal No. | Erythema | Edema | |
| Day 8 | 1 | 1 | 1 |
| 2 | 2 | 1 | |
| 3 | 2 | 0 | |
| Day 15 | 1 | 0 | 0 |
| 2 | 0 | 0 | |
| 3 | 0 | 0 |
Irritation signs were fully reversible.
Applicant's summary and conclusion
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