Registration Dossier
Registration Dossier
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EC number: 226-285-3 | CAS number: 5343-92-0
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: Guideline study (OECD)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- Department of Toxicology, BASF AG
Test material
- Reference substance name:
- Pentane-1,2-diol
- EC Number:
- 226-285-3
- EC Name:
- Pentane-1,2-diol
- Cas Number:
- 5343-92-0
- Molecular formula:
- C5H12O2
- IUPAC Name:
- pentane-1,2-diol
- Details on test material:
- - Name of test material (as cited in study report): 1,2-Pentandiol
- Test substance number: 91/369
- Physical state: liquid, achromatic
- Lot/batch No.: Abl. No. 49-0372
- Date of manufacturing: July 1991
- Storage condition of test material: room temperature
- Analytical purity: > 99%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler; D-W6050 Offenbach, Germany
- Identification: ear tattoo
- Age at study initiation: Young adult animals
- Weight at study initiation: 3.01, 2.62, 2.93 kg
- Housing: individually in cage made of stainless steel with wire mesh walk floors (floor area: 40 cm x 51 cm); No bedding in the cages; sawdust in the waste trays
- Diet (e.g. ad libitum): ad libitum, KLIBA Labordiät 341, 4 mm; Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water (e.g. ad libitum): ad libitum, about 250 ml tap water per animal per day
- Acclimation period: at least 1 week
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: 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): 100% - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: third of the back or flank s
- Type of wrap if used: The test substance has been covered with a test patch (Idealbinde, Pfälzische Verbandstoff-Fabrik, D-W6750 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 OECD Guideline 404 (adopted May 12, 1981) and EEC L 251, B.4. (Sept. 19, 1984):
Erythema and esshar formation:
0 = No erythema
1 = Very slight erythema (barely perceptible)
2 = Well defined erythema
3 = Moderate to severe erythema
4 = Severe erythema (beet redness) to eschar formation preventing grading of erythema
Edema formatlon:
0 = No edema
1 = Very slight edema (barely perceptible)
2 = Slight edema (edges of area well defined by definite raising)
3 = Moderate edema (raised approx. 1 mm)
4 = Severe edema (raised more than 1 mm and extending beyond area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
Any other information on results incl. tables
Results:
animal 1: male, 3.01 kg
animal 2: male, 2.62 kg
animal 3: male, 2.93 kg
| Readings | Animal | Erythema | Edema |
| 1h | 1 | 0 | 0 |
| 2 | 1 | 0 | |
| 3 | 0 | 0 | |
| 24 h | 1 | 0 | 0 |
| 2 | 0 | 0 | |
| 3 | 0 | 0 | |
| 48 h | 1 | 0 | 0 |
| 2 | 0 | 0 | |
| 3 | 0 | 0 | |
| 72 h | 1 | 0 | 0 |
| 2 | 0 | 0 | |
| 3 | 0 | 0 | |
| mean 24 - 72 h | 1 | 0 | 0 |
| 2 | 0 | 0 | |
| 3 | 0 | 0 | |
| mean | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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