Registration Dossier
Registration Dossier
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EC number: 259-910-3 | CAS number: 55934-93-5
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:
- 2 001
- Report date:
- 2001
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:
- [(butoxymethylethoxy)methylethoxy]propan-1-ol
- EC Number:
- 259-910-3
- EC Name:
- [(butoxymethylethoxy)methylethoxy]propan-1-ol
- Cas Number:
- 55934-93-5
- Molecular formula:
- C13H28O4
- IUPAC Name:
- 1-[2-(2-butoxy-1-methylethoxy)-1-methylethoxy]propan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Solvenon TPNB Test substance no. 01/0022-1
- Physical state: liquid clourless clear
- Analytical purity: report no. 01L00014
- Purity test date: Apr 14, 2000
- Stability under test conditions: guaranteed for the duration of the study
- Storage condition of test material: 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: Harlan-Winkelmann GmbH, Borchen, Germany
- Age at study initiation: about 7 months
- Weight at study initiation: 3.20-3.39 kg
- Fasting period before study: none
- Housing: singel housing in stainless steel wire mesh cages with gating
- Diet: Kliba-Laboratory diet, Provima Kliba SA, Kaiseraugst, Swiss ad libitum
- 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 hrs
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other:
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: upper third of the back or flanks
- Type of wrap if used: semiocclusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lutrol/water 1:1
- Time after start of exposure: 4h
SCORING SYSTEM:
Erythema and Eschar 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 slight, eschar formation (injuries in depth)
Edema Formation:
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 the area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: see table below for details
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (animal 1-3)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Other effects:
- Slight to moderate erythema, in 1 animal extending beyond the area of exposure, was observed in all animals during the course of the study. No edema was noted. The cutaneous reactions were reversible in all animals within 8 days after removal of the patch at latest. The average score (24 to 72 hours) for irritation was calculated to be 1.6 for erythema and 0.0 for edema.
Any other information on results incl. tables
Readings |
Animal |
Exposure period: 4 h |
||
Erythema |
Edema |
Additional findings |
||
1 h |
1 |
1 |
0 |
|
2 |
2 |
0 |
||
3 |
2 |
0 |
||
24 h |
1 |
2 |
0 |
15 |
2 |
2 |
0 |
||
3 |
2 |
0 |
||
48 h |
1 |
2 |
0 |
15 |
2 |
2 |
0 |
||
3 |
1 |
0 |
||
72 h |
1 |
1 |
0 |
|
2 |
2 |
0 |
||
3 |
0 |
0 |
SD |
|
8 d |
1 |
0 |
0 |
|
2 |
0 |
0 |
||
Mean 24h, 48h, 72 h |
1 |
1.7 |
0 |
|
2 |
2.0 |
0 |
||
3 |
1.0 |
0 |
||
Mean |
1.6 |
0 |
||
Symbols:
15 = Erytema extending beyond the area of exposure
SD = Study discontinued because the animal was free of symptomes
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
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