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Diss Factsheets
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EC number: 231-445-0 | CAS number: 7554-65-6
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-methylpyrazole
- EC Number:
- 231-445-0
- EC Name:
- 4-methylpyrazole
- Cas Number:
- 7554-65-6
- Molecular formula:
- C4H6N2
- IUPAC Name:
- 4-methyl-1H-pyrazole
- Details on test material:
- - Name of test material (as cited in study report): 4-Methylpyrazol
- Description: pale yellow liquid
- Storage conditions: at room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Weight at study initiation: 2.8 ± 0.2 kg
- Housing: individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm)
- Diet: ad libitum, 112 C pelleted diet (UAR, 91360 Villemoisson-sur-Orge, France)
- Water: ad libitum, water filtered by a FG Millipore membrane (0.22 micron)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- Application volume: 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: right flank
- Type of wrap if used: The substance was placed on dry gauze pad. The gauze pad was held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and restraining bandage.
REMOVAL OF TEST SUBSTANCE
- No residual substance was observed on removal of the dressing
- Time after start of exposure: 4 hours
SCORING SYSTEM: THe skin was examined approximately 1, 24, 48 and 72 hours after removal of the dressing.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 hours
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: Necrosis was observed.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 hours
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: Necrosis was observed; The animal was sacrificed 24 hours after exposure, because of the severe reaction.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 hours
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: Necrosis was observed.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24 hours
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: Necrosis was observed; The animal was sacrificed 24 hours after exposure, because of the severe reaction.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- In one animal (#2), a severe erythema, a severe oedema and cutaneous necrosis were observed on days 1 and 2. This animal was killed for ethical reasons on day 2. In a second animal (#3), a very slight or well-defined erythema was recorded between day 1 and day 4. Dryness of the skin was noted between day 5 and day 7. In the third animal (#1), a very slight to moderate erythema and very slight or slight oedema were noted from day 1 up to day 9. A slight cutaneous necrosis (0.5 cm diameter) was observed in this animal from day 1 up to day 5. Dryness of the skin and crusts were then recorded at the treatment site and persisted up to the end of the observation period.
A microscopic examination of a skin sample taken from the sacrificed animal (#2) showed the following microscopic findings:
- moderate epidermal necrosis, as assessed by nuclear pycnosis and strong eosinophilia of nuclei and cytoplasms; in addition a focal cleft within necrotic epidermis was seen
- moderate heterophil infiltration in the uppermost papillary dermis,
- moderate pilo-sebaceous atrophy (hair follicles, sebaceous glands, arrector-pili muscles),
- slight collagen degradation of the dermis extending to lower part of reticular dermis,
- slight congestion of the blood vesseis in die middle/lower part of reticular dermis,
- slight hemorrhage in the dermis (middle part/lower part of reticular dermis).
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information
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