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Diss Factsheets
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EC number: 216-088-0 | CAS number: 1493-27-2
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well conducted, sufficiently detailed, according to standardised guidelines but not GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test substance is orally administered daily in graduated doses to several groups of experimental animals, one dose level per group for a period of 5 weeks. During the period of administraion the animals are observed closely, each day for signs of toxicity.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 1-fluoro-4-nitrobenzene
- EC Number:
- 206-502-8
- EC Name:
- 1-fluoro-4-nitrobenzene
- Cas Number:
- 350-46-9
- Molecular formula:
- C6H4FNO2
- IUPAC Name:
- 1-fluoro-4-nitrobenzene
- Details on test material:
- - Name of test material (as cited in study report): p. fluoronitrobenzene
- Substance type: Halogene
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 5 weeks
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5, 15 and 45 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 10 per sex per dose
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: YES
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: after 2, 5, 7 and 9 weeks
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: 5M/5F after 2 weeks, 5M/5F after 5 weeks, 5M/5F after 7 weeks and 5M/5F after 9 weeks
- Parameters checked in table [No.?] were examined.
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes (liver, kidneys and spleen) - Other examinations:
- No
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- PRE-TEST RESULTS:
In a pre-test, rats were orally administered the test substance at 50, 100 and 200 mg/kg bw/day. At 200 mg/kg bw/day, mortality was rapidly induced by the test substance in all animals. At 100 and 50 mg/kg bw/day, hematological effects were observed : anaemia with reticulocytosis and increasedof blood platelet (methemoglobinemia: 20 %).
At gross necropsy an enlargement of the spleen was observed. Histopatology results showed a significant effect of the test substance at 100 mg/kg bw/day at liver, spleen, kidney and testicules level. At 50 mg/kg bw/day, an effect at the spleen level was only observed.
MAIN TEST RESULTS:
CLINICAL SIGNS AND MORTALITY
No mortality was observed at any tested doses.
BODY WEIGHT AND WEIGHT GAIN
The weigth gain was similar between control and treated animals.
HAEMATOLOGY
A hemaological toxicity was observed after treatment with graduated doses of the test substance. (cf. Table 1)
Effect on percentage of Methemoglobinemia, significant at 15 and 45 mg/kg/d. This effect is reversible after 2 weeks of rest
GROSS PATHOLOGY
At 45 mg/kg bw/day, all animals showed hypertrophy of the spleen.
HISTOPATHOLOGY: NON-NEOPLASTIC
After 5 weeks, histological results showed a dose-dependant congestion of the spleen with a splenic hemosiderosis. After 9 weeks, only clusters of hemosiderin in macrophages were observed. After 4 weeks of rest, the spleen congestion disappeared, but hemosiderosis is observed and important at 45 mg/kg/d.
Effect levels
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 5 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Methemoglobinemia
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 5 mg/kg bw/day (nominal)
- System:
- haematopoietic
- Organ:
- blood
- spleen
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- yes
Any other information on results incl. tables
Table 1: Hematological effect of the test substance
Treatment | Erythroctes (E+03) and Methemoglobinemia (%) |
|||
2 weeks | 5 weeks | 7 weeks | 9 weeks | |
Control | 7840 | 8495 (3.32) |
8196 (2.0) |
8002 (2.2) |
45 mg/kg bw/day | 6050 | 6536 (9.30) |
7662 (3.5) |
7828 (3.0) |
15 mg/kg bw/day | 6454 | 7277 (8.76) |
/ | / |
5 mg/kg bw/day | 6516 | 7940 (5.70) |
/ | / |
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this test, the test substance induced hematological effects with a modification of the structure of the spleen.
- Executive summary:
Male and female rats (10 per sex per dose) were orally administered 5, 15 and 45 mg/kg bw/day of the test substance daily during 5 weeks. At the end of the exposure, half of the animals were sacrificed and the others were kept for 4 weeks without treatment to detect recovery from toxic effects. Animals were examined for hematological effects (haemoglobin concentraion, hematocrit, platelet count, erythrocyte count). The test substance induced mainly hematological effects with alteration of the spleen. Nevertheless, as soon as the treatment is finished all animals showed reversibility of the observed effects.
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