Registration Dossier
Registration Dossier
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EC number: 204-068-4 | CAS number: 115-18-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable study report which meets basic scientific principles, but has deviations from current testing protocols, i.e. occlusive application, treatment duration, animal numbers.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
- Principles of method if other than guideline:
- Skin irritation was tested using an internal standard method (BASF test)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-methylbut-3-en-2-ol
- EC Number:
- 204-068-4
- EC Name:
- 2-methylbut-3-en-2-ol
- Cas Number:
- 115-18-4
- Molecular formula:
- C5H10O
- IUPAC Name:
- 2-methylbut-3-en-2-ol
- Details on test material:
- - Name of test material (as cited in study report): 2-methylbut-3-en-2-ol
- Analytical purity: 98.5-99%
- Physical state: clear liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler (breeder/ own breeding
- Mean weight at study initiation: 2.91 kg (females)
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Duration of treatment / exposure:
- 1, 5, 15 min, 20 h
- Observation period:
- 8 d
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: area of 2.5*2.5 cm on trunk of animal
- Type of wrap if used: moistened cotton lint
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol, Lutrol:water (1:1)
- Time after start of exposure: 1, 5, 15 min
SCORING SYSTEM:
The original BASF grading was converted into the numerical grading according to the OECD Draize system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 1,2
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 20 h exposure - desquamation; see table for details
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 1,2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: 20 h exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 1,2
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: 15 min exposure - necrosis in 1 animal; desquamation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 1,2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 15 min exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 1,2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 5 min exposure - desquamation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 1,2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: 5 min exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 1,2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 1 min exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 1,2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: 1 min exposure
Any other information on results incl. tables
Results:
short term tests: animal 1: female, 2.9 kg; animal 2: female, 2.92 kg
20 h test: animal 1: female, 2.92 kg, animal 2: female, 2.9 kg
| Readings | Animal | Exposure period: 1 min | Exposure period: 5 min | Exposure period: 15 min | Exposure period: 20 h | ||||||||
| Erythema | Edema | Additional findings | Erythema | Edema | Additional findings | Erythema | Edema | Additional findings | Erythema | Edema | Additional findings | ||
| 24 h | 1 | 0 | 0 | 0 | 0 | 2 | 0 | b | 2 | 0 | |||
| 2 | 1 | 0 | 1 | 0 | 2 | 0 | b | 1 | 0 | ||||
| 48 h | 1 | 0 | 0 | 1 | 0 | 2 | 0 | b | 2 | 0 | |||
| 2 | 1 | 0 | 1 | 0 | 2 | 2 | n | 1 | 0 | ||||
| 72 h | 1 | 0 | 0 | 0 | 0 | d | 2 | 0 | d | 2 | 0 | ||
| 2 | 1 | 0 | 1 | 0 | 2 | 2 | n | 1 | 0 | ||||
| 4 d | 1 | 0 | 0 | 0 | 0 | d | 2 | 0 | d | 1 | 0 | ||
| 2 | 1 | 0 | 1 | 0 | 2 | 2 | n | 1 | 0 | ||||
| 7 d | 1 | 0 | 0 | 0 | 0 | d | 1 | 0 | sd | 0 | 0 | d | |
| 2 | 0 | 0 | 0 | 0 | d | 2 | 0 | n, d | 0 | 0 | d | ||
| 8 d | 1 | 0 | 0 | 0 | 0 | d | 0 | 0 | sd | 0 | 0 | d | |
| 2 | 0 | 0 | 0 | 0 | 2 | 0 | n, d | 0 | 0 | d | |||
| Mean 24 - 72 h | 1 | 0.0 | 0.0 | 0.3 | 0.0 | 2.0 | 0.0 | 2.0 | 0.0 | ||||
| 2 | 1.0 | 0.0 | 1.0 | 0.0 | 2.0 | 1.3 | 1.0 | 0.0 | |||||
| Mean | 0.5 | 0.0 | 0.7 | 0.0 | 2.0 | 0.7 | 1.5 | 0.0 | |||||
b: brown/ brown-yellow coloured
d: desquamation
sd: slight desquamation
n: necrosis (leather-like, hard necrosis)
Applicant's summary and conclusion
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