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EC number: 208-156-3 | CAS number: 513-35-9
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- other: Non-GLP, available as unpublished report, near guideline study, minor restrictions in design and/or reporting but otherwise adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-methylbut-2-ene
- EC Number:
- 208-156-3
- EC Name:
- 2-methylbut-2-ene
- Cas Number:
- 513-35-9
- Molecular formula:
- C5H10
- IUPAC Name:
- 2-methylbut-2-ene
- Details on test material:
- - Name of test material (as cited in study report): 2-methyl-2-butene
- Physical state: Strong smelling, colourless liquid with a specific gravity of 0.66
- Stability under test conditions: stable for duration of experiment, expiry date 1 January 1981
- Storage condition of test material: in fridge
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Shell Toxicology Laboratory, Breeding Unit, Tunstall, UK
- Age at study initiation: 4-6 months
- Weight at study initiation: 2982-4208 g males, 3930-4915 g males
- Housing: Individually in hanging stainless steel cages with all mesh floors and tops and half mesh fronts (58 x 43 x 43 cm)
- Diet: SG1 with vitamin C supplement (Grain Harvesters Ltd.) ad libitum
- Water: Filtered public water ad libitum.
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 16-19 °C
IN-LIFE DATES: From: 7 May 1980 To: 18 July 1980
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: closely shorn. One site abraded and one site intact
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 2cm x 2 cm
- Type of wrap if used: 2 cm x 2 cm lint patch, occluded by an impervious polythene sheet held in place with elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed
- Time after start of exposure: Dressings removed after 24 hours
SCORING SYSTEM: Graded scale of 0-4 for both erythema and oedema
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.8
- Remarks on result:
- other: non-abraded skin sites only
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.6
- Remarks on result:
- other: non-abraded skin sites only
- Irritation parameter:
- other: Primary irritation score (according to Draize)
- Basis:
- mean
- Score:
- 1.79
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: mildly irritating to skin (grade 4)
- Irritant / corrosive response data:
- Application sites at day 7 were dry and flaking.
Any other information on results incl. tables
Table1: Individual and mean skin irritation scores of 2-methyl-2-butene (non-abraded skin) according to the Draize scheme
Time |
Erythema |
Oedema |
||||||||||
Animal number |
1564F |
1565F |
1573F |
1574M |
1576M |
1575M |
1564F |
1565F |
1573F |
1574M |
1576M |
1575M |
after 24 hours |
1 |
1 |
0.5 |
1 |
0 |
0 |
1 |
0.5 |
0.5 |
1 |
0 |
0 |
after 48 hours |
1.5 |
2 |
0.5 |
1 |
0 |
0 |
1 |
1 |
0.5 |
1 |
0 |
0 |
after 72 hours |
1.5 |
2 |
1 |
1 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
mean score 24-72 h |
0.8 |
0.6 |
||||||||||
after 7 days |
2 |
2 |
1 |
2 |
0 |
0 |
1 |
1 |
1 |
2 |
0 |
0 |
Table2: Individual and mean skin irritation scores of 2-methyl-2-butene (abraded skin) according to the Draize scheme
Time |
Erythema |
Oedema |
||||||||||
Animal number |
4915 |
3930 |
4155 |
4208 |
4030 |
3074 |
4915 |
3930 |
4155 |
4208 |
4030 |
3074 |
after 24 hours |
1 |
1 |
1 |
2 |
1 |
0.5 |
1 |
0.5 |
0.5 |
1 |
0.5 |
0 |
after 48 hours |
1.5 |
2 |
1.5 |
2 |
1 |
0.5 |
1 |
1 |
0.5 |
1 |
0.5 |
0 |
after 72 hours |
2 |
2 |
2 |
2 |
1 |
0.5 |
1 |
1 |
0.5 |
1 |
0.5 |
0 |
mean score 24-72 h |
1.4 |
0.6 |
||||||||||
after 7 days |
2 |
2 |
2 |
2 |
1 |
0.5 |
1 |
1 |
1 |
2 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- 2-methyl-2-butene was mildly irritating to rabbit skin (grade 4).
- Executive summary:
- 2-methyl-2-butene was mildly irritating to rabbit skin (grade 4).
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