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EC number: 448-100-7 | CAS number: 70441-63-3
- 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:
- 14 Sep - 28 Sep 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- Version / remarks:
- Adopted in 1992
- Deviations:
- yes
- Remarks:
- Mean temperature and relative humidity values in the animal room slightly exceeded the current guideline values. These deviations do not affect the final outcome of the study.
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 448-100-7
- EC Name:
- -
- Cas Number:
- 70441-63-3
- Molecular formula:
- C9H12FN
- IUPAC Name:
- 4-fluoro-N-(propan-2-yl)aniline
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, England
- Age at study initiation: adult, not further specified
- Body weight: 3.6, 4.0, and 3.2 kg
- Housing: Rabbits were individually housed in stainless steel cages with flat rod bases or plastic cages with perforated bases. Excrement trays beneath the cages contained low-dust (wood) bedding (type S 8/15, Ssniff Spezialdiäten GmbH, Soest, Germany).
- Diet: standard diet Ssniff K4 (Ssniff Spezialdiäten GmbH, Soest, Germany), approx. 100 - 120 g/animal/day; once per day in the morning.
- Water: tap water of drinking-water quality, ad libitum.
- Acclimation period: two weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23
- Humidity (%): 60 - 80
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 14 Sep 1993 To: 28 Sep 1993
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 500 µL
- Concentration (if solution): undiluted, pure test substance - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1 h, 24 h, 48 h, 72 h, 7 days and 14 days after removal of the patch; observation period till study termination was 14 days
- Number of animals:
- 3 female animals
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- % coverage: 500 µL of the test substance were applied to a hypoallergenic Hansamed®-patch. The treated skin area was approx. 6 cm² in size.
- Type of wrap if used: semiocclusive dressing (Fixomull®-Stretch Klebevlies (adhesive fleece), Beiersdorf no. 2293)
REMOVAL OF TEST SUBSTANCE
- Washing: After an exposure period of four hours, the dressing and patches were removed. The exposed skin areas were carefully washed with water without altering the existing response, or the integrity of the epidermis.
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1 h, 24 h, 48 h, 72 h, 7 days and 14 days after removal of the patch
SCORING SYSTEM
DRAIZE
Erythema and eschar formation:
0 = no erythema
1 = very slight erythema (barely perceptible)
2 = well-defined erythema
3 = moderate to severe erythema
4 = severe erythema (4R) to slight eschar formation (4S) (injuries in depth)
Edema formation:
0 = no edema
1 = very slight edema (barely perceptible)
2 = slight edema (edges of area well defined by definite raising)
3 = moderate edema (raised approx. 1 mm)
4 = severe oedema (raised more than 1 mm and extending beyond area of exposure)
Any serious lesions or toxic effects other than dermal irritation were also recorded and fully described.
- Method of calculation: For each animal the DRAIZE scores recorded approx. 24, 48, and 72 hours after application were added up. The total of these three values was divided by three to give the irritation index. This index was separately calculated for erythema/eschar formation and for edema formation. Where three animals were used, interpretation was based on the individual indices obtained from the two most sensitive animals. Where more than three animals were used, the mean irritation index was calculated by averaging the total scores of all rabbits tested. If delayed reactions occurred, or where no irritation indices could be calculated (e. g. due to coloration by the test substance) other interpretation criteria were applied.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Exposure of the test substance to the skin resulted in erythematous and exsudative reactions in all three animals; signs did not prove to be reversible up to day 14. These results indicate that the test substance is irritating to the skin.
Seven days post exposure a white squamous coat appeared on the treated skin.
Any other information on results incl. tables
Table 1. Results of dermal irritation/corrosion testing with female New Zealand White rabbits exposed for 4 hours to N-Isopropyl-4-fluoroaniline
Animal no. | Body weight (kg) | Draize grade after | |||||||||||
1 h | 24 h | 48 h | 72 h | 7 d | 14 d | ||||||||
e | o | e | o | e | o | e | o | e | o | e | o | ||
1 | 3.6 | 1 | 0 | 2 | 2 | 1 | 1 | 1 | 1 | 1 | 1f | 2 | 0 |
2 | 4.0 | 2 | 2 | 2 | 1 | 3 | 1 | 2 | 0 | 2 | 1 | 2 | 0f |
3 | 3.2 | 2 | 2 | 2 | 2 | 3 | 1 | 2 | 0 | 1 | 0f | 1 | 0 |
e = erythema and eschar formation
o = oedema formation
f = white squamous coat
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Exposure of the test substance to the skin resulted in erythematous and exsudative skin reactions in all three tested animals. Signs were not reversible up to study day 14.
The Draize scoring results and the missing of full reversibility provide evidence for the test substance to be irritating to skin, thus waranting classification and labeling as Cat 2 H315 according to GHS.
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