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Diss Factsheets
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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 Jun - 22 Jul 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
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:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SPF-bred Wistar rats (Wsd/Win:WU strain, formerly named: Bor: WISW (SPF Cpb)) from Harlan-Winkelmann GmbH, Borchen, Germany
- Females nulliparous and non-pregnant: yes
- Age at delivery on 25 Jun and 02 Jul 1993: males were 7 - 8 weeks of age, females were 9 - 10 weeks of age
- Mean body weight at study initiation: males: 169 g; females 156 g
- Fasting period before study: approximately 16 hours before and 4 hours after test substance administration feed was withdrawn from animals
- Housing: Animals were conventionally housed in Makrolon cages type III on low-dust wooden granulate (Source: Ssniff, Soest/Westfalen, Germany). Animals were group housed; 5 animals per cage.
- Diet: "fixed-formula" standard diet, Altromin® 1324 pellets (Source: Altromin GmbH und Co KG, Lage, Germany), ad libitum. Composition and potential contamination of diet was analysed on a routine basis.
- Water: tap water of drinking water quality, ad libitum.
- Acclimation period: at least 5 days
- Microbiological status: SPF-bred rats were used
- Method of randomisation in assigning animals to test and control groups: Animals were assigned to study groups based on random numbers from a randomlist.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 5
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 30 Jun To: 22 Jul 1993
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- physiological saline
- Remarks:
- plus 2 % Cremophor EL (v/v)
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
DOSAGE PREPARATION
Test substance was formulated in physiological saline with 2 % Cremophor EL under continuous stirring. Detailed analyses of test substance identity, stability and homogeneity were conducted. - Doses:
- 200, 633, and 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: On the day of test substance administration animals were repeatedly observed for clinical signs of toxicity. During the 14-day observation period animals were observed twice daily. On weekends and public holidays animals were observed once daily. Animals were weighed directly before, one week after and two weeks after (end of observation period) test substance administration.
- Clinical signs including body weight : type, start, duration, and intensity of clinical signs was recorded. - Statistics:
- Calculation of the median lethal dose.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 356 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals of the lowest dose group (200 mg/kg bw) survived until scheduled sacrifice.
All animals of both, the mid and the high dose group (633 and 2000 mg/kg bw) died within 8 hours following single administration of the test substance by gavage. - Clinical signs:
- other: Clinical signs of toxicity were reported for the mid and high dose groups (663 and 2000 mg/kg bw) whereas no such signs were seen at the lowest tested dose of 200 mg/kg bw. The clinical signs observed included sedation, paleness and ruffled fur. Signs of
- Gross pathology:
- Findings at necropsy:
2000 mg/kg bw: stomac filled with white liquid
633 mg/kg bw: inflated stomac filled with liquid, reddened lungs. Additionally, the liver of the females of this dose group was pale and spotted.
200 mg/ kg bw: No gross pathological abnormalities were found in the animals sacrificed at study termination.
Any other information on results incl. tables
Table 1. Mortality and incidence of clinical signs
Dose [mg/kg bw] |
Mortality |
Clinical signs |
|
N* |
N* |
Males |
||
200 |
0/5 |
0/5 |
633 |
5/5 |
5/5 |
2000 |
5/5 |
5/5 |
Females |
||
200 |
0/5 |
0/5 |
633 |
5/5 |
5/5 |
2000 |
5/5 |
5/5 |
*N= Number of animals/ number of animals used
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Examining the test substance for acute oral toxicity in male and female Wistar rats resulted in a LD50 value of 356 mg/kg bw.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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