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EC number: 208-156-3 | CAS number: 513-35-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Based on assessment of the available data for 2-methylbut-2-ene (2M2B) should be considered as mildly irritating to skin and non-irritating to eyes. The respiratory tract irritation potential of 2M2B is not known, as no data are available for this endpoint.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- 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 - 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 - 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.
- 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).
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- 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 - 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 - 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
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin Irritation
Studies in Animals
An occlusive patch test based on the method of Draize (1975) was used to assess the primary skin irritation induced by 2M2B applied neat. The mean erythema and oedema scores for abraded and non-abraded skin were 0.8 and 0.6 i.e. <2 and <1 respectively. The primary irritation score calculated according to the method of Draize was 1.79.
On this basis 2M2B may be regarded as being mildly irritating to rabbit skin. The erythema and oedema scores at 7 days were higher than those at 72 hours but at 7 days all the skin patches were beginning to dry out and flake. It is possible the animals scratching these areas was a contributory factor, resulting in the slightly higher erythema scores (SRC, 1980).
Studies in Humans
No human information available
Eye Irritation
Studies in Animals
The method of Draize (1963) was used to assess the eye irritancy of 2M2B in New Zealand White rabbits. Instillation of 2M2B into the eye resulted in a moderate initial pain response (grade 4) in all animals. Mean total scores for the responses of the conjunctiva, cornea and iris were 0.5, 0 and 0 (i.e. all ≤0.5) and based on these results, 2M2B should be considered as non-irritating to rabbit eyes (SRC, 1980).
Studies in Humans
No human information available
Respiratory Tract Irritation
No studies on respiratory tract irritation have been conducted with 2M2B. From the acute inhalation study and repeat dose study (HLS, 2003) there is no specific evidence of acute irritation effects warranting classification.
Justification for selection of skin irritation / corrosion endpoint:
Available data indicate the occurrence of mild persistent skin irritation
Justification for selection of eye irritation endpoint:
Available data indicate no potential to cause eye irritation
Effects on skin irritation/corrosion: slightly irritating
Justification for classification or non-classification
Based on assessment of the available data, 2M2B does not warrant classification as a respiratory tract or eye irritant under CLP.
For skin irritation, all responses were below the threshold scores for classification however on the basis of criteria that inflammation of the skin is also significant if it persists in at least two animals (implied of 3, i.e. 4 of 6) at the end of the observation time, classification as category 2 (H315: causes skin irritation) may be warrented under CLP.
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