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EC number: 606-870-3 | CAS number: 219715-34-1
- 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:
- January 11 - 14, 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to recognised guidelines and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-methoxy-4-(trifluoromethyl)pyridine
- EC Number:
- 606-870-3
- Cas Number:
- 219715-34-1
- Molecular formula:
- C7H6F3NO
- IUPAC Name:
- 2-methoxy-4-(trifluoromethyl)pyridine
- Details on test material:
- - Name of test material (as cited in study report): M-TMP
- Physical state: colourless liquid
- Analytical purity: 99.7%
- Lot/batch No.: 041206-7D
- Expiration date of the lot/batch: n/a
- Stability under test conditions: Test substance was expected to be stable for the duration of testing.
- Storage condition of test material: room temperature
- pH: 6-7 (by wetted pH paper)
- Solubility: Soluble in methanol, ethanol, and acetone.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Received from Robinson Services, Inc. Gammons, NC on December 29, 2004.
- Age at study initiation: Young adult.
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed eneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): Purina Certified Rabbit Diet PMI #5322
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum by an automatic water dispensing system.
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 55-62%
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Five-tenths of a milliliter of the test substance was applied - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, and 72 hours
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2 intact dose site
- Type of wrap if used: Each animal was covered with a 1-inch x 1-inch, 4-ply gauze pad. The pad and entire trunk of each animal were then wrapped with semi-occlusive 3-inch Micropore tape to avoid dislocation of the pad. Elizabethan collars were placed on each rabbit and they wore returned to their designated cages.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The pads and collars were removed and the test sites were gently cleansed of any residual test substance.
- Time after start of exposure: After 4 hours of exposure
SCORING SYSTEM:
Individual dose sites were scored according to the Draize scoring system:
Evaluation of Skin Reactions Value
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 slight eschar formation (injuries in depth) 4
Edema formation:
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 millimeter) 3
Severe edema (raised more than 1 millimeter and extending beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effect noted
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects noted
- Irritant / corrosive response data:
- Within 24 hours after patch removal, all three treated sites exhibited very slight to well-defined erythema and very slight edema. The overall incidence and severity of irritation decreased with time. All animals were free of dermal irritation within 72 hours.
- Other effects:
- One animal exhibited soft feces on Day 3. The other two animals appeared active and healthy during the entire observation period.
Any other information on results incl. tables
TABLE 1: INDIVIDUAL SKIN IRRITATION SCORES
ERYTHEMA/EDEMA
Animal No. | Sex | Hours After Patch Removal | |||
1 | 24 | 48 | 72 | ||
13481 | M | 2/1 | 2/1 | 2/13 | 0/03 |
13482 | M | 2/1 | 2/1 | 1/13 | 0/03 |
13483 | M | 2/1 | 1/1 | 1/03 | 0/03 |
Total | 6/3 | 5/3 | 4/2 | 0/0 | |
Mean | 2.0/1.0 | 1.7/1.0 | 1.3/0.7 | 0.0/0.0 |
3 Desquamination noted
TABLE 2: SUMMARY OF PRIMARY SKIN IRRITATION SCORES4
Hours | ||||
1 | 24 | 48 | 72 | |
Erythema | 2.0 | 1.7 | 1.3 | 0 |
Edema | 1.0 | 1 | 0.7 | 0 |
TOTAL (PDI)5 | 3.0 | 2.7 | 2.0 | 0 |
4 Average values for three rabbits.
5 PDI= Average Erythema + Average Edema
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, M-TMP caused very slight to well-defined erythema and very slight edema which cleared by 72 hours.
- Executive summary:
A primary skin irritation test was conducted with rabbits to determine the potential for M-TMP to produce irritation after a single topical application. Under the conditions of this study, the test substance caused very slight to well-defined erythema and very slight edema which cleared by 72 hours.
Five-tenths of a milliliter of the test substance was applied to the skin of three healthy rabbits for 4 hours. Following exposure, dermal irritation was evaluated by the method of Draize et al.
Within 24 hours after patch removal, all three treated sites exhibited very slight to well-defined erythema and very slight edema. The overall incidence and severity of irritation decreased with time. All animals were free of dermal irritation within 72 hours,
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