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EC number: 207-236-5 | CAS number: 455-14-1
- 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:
- from 8 jul 1985 to 19 aug 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to the standardised method but no data about GLP.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- α,α,α-trifluoro-p-toluidine
- EC Number:
- 207-236-5
- EC Name:
- α,α,α-trifluoro-p-toluidine
- Cas Number:
- 455-14-1
- Molecular formula:
- C7H6F3N
- IUPAC Name:
- 4-(trifluoromethyl)aniline
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Species: rabbit
- Strain: New Zealand White
- Source: Charles River : F 76410 - Saint-Aubin-lès-Elbeuf ; E.G.A.V. : Saint-Mars-d'Egrenne - F 61350 - Passais-la-Conception ; Elevage Scientifique des Dombes : Roman - F 01400 - Chatillonsur-Chalaronne.
- Age at study initiation: no data
- Weight at study initiation: 2.5 kg (± 200 g)
- Housing : The rabbits are kept in individual polystyrene cages, measuring 540 x 360 x 315 mm with a perforated polystyrene floor in a ventilated and air conditioned room. Lighting is artificial for 12 hours per day (7.30 a.m. - 7.30 p.m.).
- Diet : 150 g of complete maintenance food (granulés Lapin Entretien "112" UAR, 91360 - Villemoisson / Orge) is provided per rabbit and per day.
- Water :ad libitum automatically (softened and filtered water : 15 µ)
- Acclimation period (durée): at least 8 days. Animals were vaccinated against the Myxomatosis (Lyomyxovax, Institut Mérieux).
ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 20°C +/-3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12 to 14 times per hour (pre-filtered air: 5-10 µ)
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: day of application 16 jul 1985. Observation period not done.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: according to the guideline, the no treated area around the application site served as control
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- no data
- Number of animals:
- 6
- Details on study design:
- TEST SITE:
- Preparation of test site: a preparation of 14*14 cm were clipped on the back and on the flank with a fine toothed electric clipper the day before the
application. A precise cut was achieved without irritating the skin mechanically. After a rest period of 24 hours, only animals with perfectly healthy
intact skin showing no macroscopic sign of irritation were retained.
- Area of exposure: the substance was applied on a codex hydrophilic eight layer gauze pad about 2.5 cm square (6.25 cm2)
- Type of wrap if used: The test substance and the gauze pad are held in contact with the skin with a semi-occlusive patch : 10 cm wide adhesive
perforated tape (Peloplast : M.S.R.) applied on a crimped gauze bandage (Creplux-Molinier) covering more particularly the whole clipped surface
(to avoid possible orthoergic reactions) and wrapped around the animal (without blocking the respiratory and abdominal movements
REMOVAL OF TEST SUBSTANCE:
- Washing: After these 4 hours of exposure, the bandages are removed, and if necessary the excess of the test substance which has not penetrated
is wiped with a gauze pad moistened with deionized water (or a non-irritant)
- Time after start of exposure: 4 hours
SCORING SYSTEM: macroscopic examinations for cutaneous primary irritation were evaluated after removal of the gauze pad (4 hours exposure)
on time 1h, (5h after the application of the substance) 24, 48 and 72h. The scale used for cotation of erythema and oedema formations is conformed with EU guideline.
Scoring interpretation were done according to appendix VI of directive 79/831.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.44
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 24h: 0.67; 48h: 0.33; 72h: 0.33 mean established for 6 animals.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not concerned
Any other information on results incl. tables
Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test:
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 2 |
|
60 min |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
24 h |
0/0/1/2*/0/1 |
0/0/0/0/0/0 |
48 h |
0/0/0/1*/0/1 |
0/0/0/0/0/0 |
72 h |
0/0/0/1*/0/1 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0.44 |
0 |
Reversibility** |
n for 2 animals |
/ |
Average time (unit) for reversion |
/ |
/ |
*: reaction out of application area
** Reversibility: n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Not irritating
- Executive summary:
In a primary dermal irritation study (Hazleton, 1985), 6 rabbits were dermally exposed to p-trifluoromethylaniline (>=98.5%) for 4 hours to 6.25 cm2 of dorsal/flank skin. Test site was covered with a semi-occlusive patch for 4 hours. Animals then were observed 1, 24, 48 an 72 hours after removal the substance.
Irritation was scored following the erythema and oedema scale of EU guideline.The mean value of erythema score was 0.44 without complete reversibility after 72h. No oedema effects were observed.
In this study, p-trifluoromethylaniline (>=98.5%) is slightly irritating but not a dermal irritant to the skin based on EU classification criteria.
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