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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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other: Non-GLP, available as unpublished report, near guideline study, minor restrictions in design and/or reporting but otherwise adequate for assessment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:
1980
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

Constituent 1
Chemical structure
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

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.