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EC number: 609-256-3 | CAS number: 365400-11-9
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 Dec - 16 Dec 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 09 Oct 2017 (corrected 14 Jun 2021)
- Deviations:
- yes
- Remarks:
- no pre-treatment with systemic analgesic and topical anesthesia
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- adopted 1998
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-[2-methanesulfonyl-4-(trifluoromethyl)benzoyl]-1,3-dimethyl-1H-pyrazol-5-ol
- EC Number:
- 609-256-3
- Cas Number:
- 365400-11-9
- Molecular formula:
- C14H13F3N2O4S
- IUPAC Name:
- 4-[2-methanesulfonyl-4-(trifluoromethyl)benzoyl]-1,3-dimethyl-1H-pyrazol-5-ol
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test material was instilled as received.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Robinson Services, Inc. Clemmons, NC, USA
- Age at study initiation: Young adult
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors.
- Diet: Pelleted Purina Rabbit Chow #5326
- Water: Filtered tap water was supplied, ad-libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 13 Dec 2005 To: 16 Dec 2005
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 40 mg (corresponding to 0.1 mL) - Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h - Duration of post- treatment incubation (in vitro):
- not applicable
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no washing was done
SCORING SYSTEM: scoring was done according to Draize
TOOL USED TO ASSESS SCORE: Ocular irritation was evaluated using a high-intensity white light (Mag Lite). A fluorescein dye evaluation was performed 24 h after instillation and as needed at subsequent scoring intervals to evaluate the extent of corneal damage or to verify reversal of effects.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1 and animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no indication of corneal opacity
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1 and animal # 3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no indication of iritis
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- all aniamls
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no indication of chemosis
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2 and animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritant / corrosive response data:
- One hour after test substance instillation, all three treated eyes exhibited iritis and conjunctivitis. By 24 h, corneal opacity (score 1) developed in one animal. The overall incidence and severity of irritation decreased thereafter. All animals were free of ocular irritation by 72 h.
Ocular discharge (score 2) was noted 1 h after treatment and to a lesser degree (score 1) 24 h after treatment in all animals. In animal #3 this discharge persisited until 48. The finding was fully reversible in all animals within 72 h. - Other effects:
- All animals appeared active and healthy during the study. Apart from the eye irritation noted below, there were no other signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior.
Any other information on results incl. tables
Table 1: Individual irritation scores
Animal number |
Effects |
1 h |
24 h |
48 h |
72 h |
Mean scores* |
1 |
Corneal opacity Iritis Redness conjunctivae Chemosis conjunctivae Discharge |
0 1 3 1 2 |
0 1 2 0 1 |
0 0 1 0 0 |
0 0 0 0 0 |
0.00 0.33 1.00 0.00 0.33 |
2 |
Corneal opacity Iritis Redness conjunctivae Chemosis conjunctivae Discharge |
0 1 2 1 2 |
0 0 2 1 1 |
0 0 1 0 1 |
0 0 0 0 0 |
0.00 0.00 1.00 0.33 0.67 |
3 |
Corneal opacity Iritis Redness conjunctivae Chemosis conjunctivae Discharge |
0 1 3 2 2 |
1 1 2 1 1 |
1 0 1 1 1 |
0 0 0 0 0 |
0.67 0.33 1.00 0.67 0.67 |
* calculated from 24 to 72 h scores
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008"
- Conclusions:
- The study was performed in accordance to EPA OPPTS 870.2400 (Acute Eye Irritation) under GLP conditions and is considered reliable. Based on the study results, the test substance is considered to be mildly irritating to eyes. However, the slight signs of irritation observed in this study were not sufficient to warrant classification for eye irritation.
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