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EC number: 204-451-6 | CAS number: 121-17-5
- 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:
- June - July 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: in accordance with guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-chloro-α,α,α-trifluoro-3-nitrotoluene
- EC Number:
- 204-451-6
- EC Name:
- 4-chloro-α,α,α-trifluoro-3-nitrotoluene
- Cas Number:
- 121-17-5
- Molecular formula:
- C7H3ClF3NO2
- IUPAC Name:
- 1-chloro-2-nitro-4-(trifluoromethyl)benzene
- Details on test material:
- - Name of test material (as cited in study report): MN
- Physical state: yellow liquid
- Lot/batch No.: RV7
- Expiration date of the lot/batch: November 1995
- Stability under test conditions: stable
- Storage condition of test material: room temperature (avoid contact with strong bases and oxidizing agents)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Conelli s.n.c. - Arona (NO)- Italy
- Age on receipt: 2-3 months
- Weight on receipt: 2-3 kg
- Housing:individual caging in T06C air conditioned room, metal cages measuring 62 x 47.5 x 38 (h) cm, with stainless feeder. The cages were hung on metal racks over a stainless waste system.
- Diet : ad libitum (GLP 2RB 15 certificate pelleted diet produced by Charles River Italia's feed licensee mucedola s.r.l. (Settimo Milanese). the diet was supplemented by the Producer with vitamins and trace elements.
- Water : ad libitum from the municipal water main system (periodically analyzed and filtered)
- Acclimation period: about 2 months.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2 °C
- Humidity (%): 50 ± 15%
- Air changes (per hr): about 15/hour
- Photoperiod (hrs dark / hrs light): artifical light with a circadian cycle of 12 hours of light.
IN-LIFE DATES: From: June 7, 1994 To: June 10, 1994
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: adjacent areas of untreated skin of each animal served as control for the test.
- Amount / concentration applied:
- 0.5 mL /animal
- Duration of treatment / exposure:
- 3 minutes, 1 and 4 hours
- Observation period:
- immediately after the 3 minutes and the 1 -hour exposure period and at 72 hours and day 8 in the first rabbit nd at 1, 24, 48, 72 hours and 8 days after the 4-hour exposure period (all rabbits).
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: trunk
- % coverage: approximately 6 cm2 of skin
- Type of wrap if used: gauze patch loosely held in contact with the skin by an impermeable, non-irritant, hypoallergenic tape.
STEPS
- 1: one rabbit was used and 3 treatment sites of the skin were prepared. On the first, the test article was applied for 3 minutes. Since no serious gross skin reaction was noted, the test article was applied for 1 hour on the second site. Since no serious gross skin reaction was observed also afterthis period, the test article was applied for an exposure period of 4 hours on the third skin site.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 3 minutes, 1 and 4 hours.
SCORING SYSTEM:
The skin reaction was scored according to the following scale:
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
Maximum possible: 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 approx 1 mm): 3
severe edema (raised more than 1 mm and extending beyond area of exposure): 4
Maximum possible: 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test article MN, when administered by dermal route to rabbits under the experimental conditions adopted, has to be considered NON IRRITANT for the skin.
- Executive summary:
An acute dermal irritation study, with a single administration of 0.5 mL of the test article MN in the New Zealand White rabbit (3 animals) was performed. No untoward clinical sign or behavioral alteration was observed. At the application site, slight transient signs of dermal irritancy were observed in all treated rabbits. No sign was evident at the 72 -hours observation in any animal.
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