Registration Dossier
Registration Dossier
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EC number: 241-793-5 | CAS number: 17832-28-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Remarks:
- in vivo study already available
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 4-(vinyloxy)butan-1-ol
- EC Number:
- 241-793-5
- EC Name:
- 4-(vinyloxy)butan-1-ol
- Cas Number:
- 17832-28-9
- Molecular formula:
- C6H12O2
- IUPAC Name:
- 4-(ethenyloxy)butan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Vinyl-4-Hydroxybutylether
- Physical state: liquid
- Analytical purity: approximately 100%
- Expiration date of the lot/batch: April 1984
- Stability under test conditions: not reported
- Storage condition of test material:not reported
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Firma Gaukler, 6050 Offenbach
- Weight at study initiation: female-3.40 kg, mean weight for males-3.13 kg
- Housing: single
- Diet: Ovator Solikanin 4 mm, Muskator-Werke, Duesseldorf (ca. 130 g/animal/day)
- Water: tap water (ca. 250 ml/animal/day)
- Acclimation period: 8 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: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml undiluted - Duration of treatment / exposure:
- 4 h
- Observation period:
- 8 days
- Number of animals:
- 3 (2 males and 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Porous dressing (Four layers absorbent guaze and porous bandage)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lutrol and lutrol/water (1:1)
- Time after start of exposure: 4 h
SCORING SYSTEM: OECD Draize Score
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: see table for further details
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: see table for further details
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: see table for further details
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- see remarks
Any other information on results incl. tables
Animal |
Reading |
Erythema |
Edema |
1 |
4 h |
1 |
0 |
2 |
4 h |
1 |
0 |
3 |
4 h |
1 |
0 |
1 |
24 h |
1 |
0 |
2 |
24 h |
1 |
0 |
3 |
24 h |
0 |
0 |
1 |
48 h |
0 |
0 |
2 |
48 h |
0 |
0 |
3 |
48 h |
0 |
0 |
1 |
72 h |
0 |
0 |
2 |
72 h |
0 |
0 |
3 |
72 h |
0 |
0 |
1 |
8 d |
0 |
0 |
2 |
8 d |
0 |
0 |
3 |
8 d |
0 |
0 |
mean |
24 - 72 h |
0,22 |
0,00 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
This study was conducted according to OECD guideline with no GLP. A cloth (2.5 x 2.5 cm) soaked with 0.5 mL of unchanged test substance was applied on the clipped skin of three rabbits under semiocclusive conditions. After 4 h the test substance was washed away. After application of the test substance for 4 h, very slight erythema was observed, which was fully reversible within 48 h. No edema was observed.
Conclusion: According to the test results, 4-(vinyloxy)butan-1 -ol is not skin irritating.
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