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Diss Factsheets
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EC number: 201-891-0 | CAS number: 89-25-8
- 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:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The identity of the test substance was not sufficiently documented. Only a summary test report was available, there was no raw data. However, the study was conducted under FDA test protocols. Appropriate dose level was used. The scoring system deviated slighty from the current OECD protocol. Control analysis was performed. Restriction for reliability was due to the age of the study (1980).
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 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- The identity of the test substance was not sufficiently documented. Only a summary test report was available, there was no raw data. However, the study was conducted under FDA test protocols. Appropriate dose level was used. The scoring system deviated slighty from the current OECD protocol. Control analysis was performed. Restriction for reliability was due to the age of the study (1980).
- Deviations:
- yes
- Remarks:
- See text above in "Version/remarks" section
- Principles of method if other than guideline:
- Before the start of the study the hair in the dorsal region of the body of 6 rabbits was remoced with an electric clipper over an area of about 3x 6 cm. One half of the clipped skin was in addition scarified with a scarificator. Each animal was treated with 500 mg of 1-Phenyl-3-methyl-5-pyrazolon pasted with 0.35 ml physiologic saline solution. The substance was evenly distributed over the whole surface of 2.3 x 2.5 cm cellulose patch on a piece of surgical plaster (Hansamed(R)). The plaster was fixed to the prepared skin area and covered with a indifferent, impermeable polyethylene film (6-8cm wide). Finally the animals body was fixed with an elastic bandage. The exposure period was 4 hours. A first examination took place immediately after removal of the patches. Further examination tool place after 48 and 72 hours post application.
- GLP compliance:
- no
Test material
- Reference substance name:
- 3-methyl-1-phenyl-5-pyrazolone
- EC Number:
- 201-891-0
- EC Name:
- 3-methyl-1-phenyl-5-pyrazolone
- Cas Number:
- 89-25-8
- Molecular formula:
- C10H10N2O
- IUPAC Name:
- 5-methyl-2-phenyl-2,4-dihydro-3H-pyrazol-3-one
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Remarks:
- Albino-Himalayan ; Hoe:HIML (SPFWiga)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: from the test facility laboratory
- Age at study initiation: not specified
- Weight at study initiation:1.7 to 2.1 kg
- Housing: animals were housed in single cages
- Diet (e.g. ad libitum): ERKA 8300 (Futtermittelwerk Tobert Koch oHG, Hamm/Wastfalen) ad libitum
- Water (e.g. ad libitum): water, ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
No information
IN-LIFE DATES: Not specified
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
VEHICLE
Vehicle was not used
NEGATIVE CONTROL
Not specified
POSITIVE CONTROL
Not specified - Duration of treatment / exposure:
- 4 hours
- Observation period:
- At the patch removal, 48 and 72 hours post application
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: dorsal region of the body
- % coverage: not specified
- Type of wrap if used: piece of surgical plaster (Hansamed (R))
REMOVAL OF TEST SUBSTANCE
Not specified
OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
At the removal, 48 and 72 hours
SCORING SYSTEM:
- Method of calculation:
Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to eschar formation (injuries in depth) preventing grading of erythema 4
Edema
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising 2
Moderate edema (raised approximately 1mm) 3
Severe edema (raised more than 1mm and extending beyond the area of exposure) 4
The scores for erythema and eschar formation as well as for edema formation obtained in each rabbit on intact or scarified skin after 24 or 72 hours was added to given the primary irritation score. The sum of all values was divided by number of animals and a factor of 4. The classification was done according to the following evaluation scale.
0-0.5 non irritationg
0.6-3.0 slighty irritant
3.1-5.0 moderately irritant
5.1-8.0 severely irritant
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Remarks:
- edema and erythema scpre per animal were not available. Only primary dermal irritation index PDII was available in the report
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Remarks:
- edema and erythema scpre per animal were not available. Only primary dermal irritation index PDII was available in the report
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- After application of the substance (pasty form) an irritation index score of 1.5 was determined. Due to classification according to the FDA guideline mentionned in the report, the substance was therefore to be described as slighty irritant. Under CLP regulation, the obtained score of 1.5 did not led to a EU-CLP classification. Hence, the test article was not classified for Skin Irritation.
- Executive summary:
The study was conducted to evluate skin irritation potential of the test article when applied on rabbit skin.
Before the start of the study the hair in the dorsal region of the body of 6 rabbits was remoced with an electric clipper over an area of about 3x 6 cm. One half of the clipped skin was in addition scarified with a scarificator. Each animal was treated with 500 mg of 1-Phenyl-3-methyl-5-pyrazolon pasted with 0.35 ml physiologic saline solution. The substance was evenly distributed over the whole surface of 2.3 x 2.5 cm cellulose patch on a piece of surgical plaster (Hansamed(R)). The plaster was fixed to the prepared skin area and covered with a indifferent, impermeable polyethylene film (6-8cm wide). Finally the animals body was fixed with an elastic bandage. The exposure period was 4 hours. A first examination took place immediately after removal of the patches. Further examination tool place after 48 and 72 hours post application.
After application of the substance (pasty form) an irritation index score of 1.5 was determined. Due to classification according to the FDA guideline mentionned in the report, the substance was therefore to be described as slighty irritant. under CLP regulation, the obtained score of1.5 did not led to a EU-CLP classification. Hence, the test article was not classified for Skin Irritation.
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