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EC number: 240-596-1 | CAS number: 16529-56-9
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not stated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Draize method but the purity is not indicated. Comparable to guideline, with acceptable restrictions (24-h exposure, observations at 25 and 48 h only, occlusive dressing).
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : 24 hours of application, only two time points instead of three, and occlusive coverage instead of semi-occlusive. No details on test material, condition and animals.
- Principles of method if other than guideline:
- Draize test: Local tolerance test in rabbit, evaluation of the index of primary cutaneous irritation on intact skin.
- GLP compliance:
- not specified
- Remarks:
- study performed before GLP statement.
Test material
- Reference substance name:
- 2-methyl-3-butenenitrile
- EC Number:
- 240-596-1
- EC Name:
- 2-methyl-3-butenenitrile
- Cas Number:
- 16529-56-9
- Molecular formula:
- C5H7N
- IUPAC Name:
- 2-methylbut-3-enenitrile
- Details on test material:
- - Name of test material (as cited in study report): 2-methyl-3-butenenitrile
- Substance type: no data
- Physical state: light yellow liquid
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Purity test date: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
- Other: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: From 2.5 kg to 3.5 kg
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded or scarified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g (or 0.5 mL)
- Concentration (if solution): no data
VEHICLE
no vehicle - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 25 and 72 hours
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: circle of 3 cm of diameter
- % coverage: no data
- Type of wrap if used: aluminium with gaze maintain with adhesive tape and enveloping bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize scoring.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- intact skin
- Time point:
- other: Overall 25 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: See details in Tables 7.3.1/1 and 7.3.1/2
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- intact skin
- Time point:
- other: Overall 25 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: See details in Tables 7.3.1/1 and 7.3.1/2
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: Overall 25 and 72 hrs
- Score:
- 0.06
- Max. score:
- 12
- Reversibility:
- fully reversible within: 72 hrs
- Remarks on result:
- other: this index is equal to the sum of the scores for erythema and edema at 25 and 72 hrs after the application for the both intact and abraded skin, divided by 16 (number of treated rabbits multiplied by 4).
- Irritant / corrosive response data:
- On the treated intact skin, no effect was observed: mean score was 0.0 for erythema and edema. On the treated abraded skin, a very slight and transient erythmea was observed for one animal. No edema was seen on the abraded skin of the other animals. See details in Tables 7.3.1/1 and 7.3.1/2
- Other effects:
- No data
Any other information on results incl. tables
Table 7.3.1/1:Mean irritant/corrosive response data for each animal with intact skin at each observation time up to removal of animals from the test
Score at time point / Reversibility |
Erythema Max. score 4 |
Edema Max. score 4 |
25 h after the start of test item application |
0/0/0/0 |
0/0/0/0 |
72 h after the start of test item application |
0/0/0/0 |
0/0/0/0 |
Average 25h, 72h (mean of all animals) |
0.0 |
0.0 |
Reversibility*) |
c/c/c/c |
c/c/c/c |
Average time (hrs) for reversion |
- |
- |
Table 7.3.1/2: Mean irritant/corrosive response data for animals with abraded skin at each observation time up to removal of animals from the test
Score at time point / Reversibility |
Erythema Max. score 4 |
Edema Max. score 4 |
25 h after the start of test item application |
0/0/1/0 |
0/0/0/0 |
72 h after the start of test item application |
0/0/0/0 |
0/0/0/0 |
Average 25h, 72h |
0.125 |
0.0 |
Reversibility*) |
-/-/c/- |
-/-/-/- |
Average time (hrs) for reversion |
-/-/72/- |
- |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under these test conditions, no irritant response was detected, 2-methyl-3-butenenitrile was not classified as a skin irritating according to EU criteria.
- Executive summary:
In a dermal irritation study performed similarly to the OECD test guideline No. 404, 4 New Zealand White rabbits were exposed to 0.5 mL of undiluted 2 -methyl-3 -butenenitrile. Skin was shaved before application; on each animal one area was intact whereas the other was abraded. Test sites were covered with an occlusive dressing for 24 hours and weren’t washed after this period. Changes were observed at 25 and 72 hours. Irritation was scored by the method of Draize. On the treated intact skin, no effect was observed. Mean score was 0.0 for erythema and edema.
Under the condition of this test, 2 -methyl-3 -butenenitrile is not a skin irritant. Thus no classification is required according to EU legislation (Regulation 1278/2008/EC and Directive 67/548/EEC).
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