Registration Dossier
Registration Dossier
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EC number: 208-156-3 | CAS number: 513-35-9
Eye irritation
Administrative data
- Endpoint:
- eye 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- other: Non-GLP, available as unpublished report, near guideline study, minor restrictions in design and/or reporting but otherwise adequate for assessment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 405 (Acute Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 mL - Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: Initial pain scored on a 1-6 scale. Eye irritation scored according to the Draize scale. Mean total scores transcribed to a grade and descriptive rating using a modification of the Kay and Calandra technique.
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour, 1, 2, 3 and 7 days
- Score:
- 0.5
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 hour, 1, 2, 3 and 7 days
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 hour, 1, 2, 3 and 7 days
- Score:
- 0
Any other information on results incl. tables
Immediately following instillation into the eye, all rabbits showed signs of moderate initial pain (grade 4).
Table 1: Eye irritation scores of 2-methyl-2-butene according to the Draize scheme
Time (hours) |
Cornea |
Iris |
Conjunctiva |
|||||||||||||||||||||
Redness |
Chemosis |
|||||||||||||||||||||||
1 |
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
24 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.5 |
0 |
0 |
0 |
0 |
0.5 |
0 |
0 |
0 |
0 |
0 |
0 |
48 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
mean 24-72 |
0 |
0 |
0 |
0 |
||||||||||||||||||||
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- 2-methyl-2-butene was non irritant to the rabbit eye.
- Executive summary:
Instillation of 2-methyl-2-butene into the eye resulted in a moderate initial pain response (grade 4) in all animals. The mean total scores for the responses of the conjunctiva, cornea and iris at 1 hour, 1, 2, 3 and 7 days were calculated and were. 0.5, 0, 0, 0 and 0 respectively.
2-Methyl-2-butene may be described as non irritating to rabbit eyes.
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