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EC number: 201-983-0 | CAS number: 90-30-2
- 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
Endpoint summary
Administrative data
Description of key information
Acute toxicity, oral
LD50 (rat) = 1625 mg/kg bw (MacEwen and Vernot, 1974)
LD50 (mouse) = 1231 mg/kg bw (MacEwen and Vernot, 1974)
Acute toxicity, dermal
LD50 (rabbit) > 5000 mg/kg bw (Weil, 1974)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- The experiments reported herein were conducted according to the "Guide for the Care and Use of Laboratory Animals", DHEW 78-23. Toxicity screening designed to evaluate the acute toxicity of N-phenyl-α-naphthylamine by use of the following test: Single Dose Oral LD50 in Rats
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200-300 g
- Fasting period before study: for at least 16 hours prior to administration
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- DOSAGE PREPARATION: Solutions of the test material were prepared such that precalculated doses could be given using dose volumes of 0.01 ml per gram of body weight.
- Doses:
- 500, 1000, 2000, 4000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
Rats were weighed individually at the time of testing to determine the proper injection volume. Any deaths occuring during this observation period were included in the final mortality figures. - Statistics:
- Mortality data was treated statistically using the moving average interpolation method of Weil (1952) for LD50 and 95 % confidence limits determinations.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 625 mg/kg bw
- 95% CL:
- ca. 1 201 - 2 197
- Mortality:
- 500 mg/kg: 0 dead/5 alive
1000 mg/kg: 0/5
2000 mg/kg: 4/5
4000 mg/kg: 5/5 - Clinical signs:
- other: no data
- Gross pathology:
- no data
- Other findings:
- no data
- Interpretation of results:
- other: Category 4
- Remarks:
- EU GHS criteria
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- The experiments reported herein were conducted according to the "Guide for the Care and Use of Laboratory Animals", DHEW 78-23. Toxicity screening designed to evaluate the acute toxicity of N-phenyl-α-naphthylamine by use of the following test: Single Dose Oral LD50 in Mice
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- mouse
- Strain:
- CF-1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 20-30 g
- Fasting period before study: for at least 16 hours prior to administration - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- DOSAGE PREPARATION: Solutions of the test material were prepared such that precalculated doses could be given using dose volumes of 0.01 ml per gram of body weight.
- Doses:
- 500, 1000, 2000, 4000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
Mice were weighed individually at the time of testing to determine the proper injection volume. Any deaths occuring during this observation period were included in the final mortality figures. - Statistics:
- Mortality data was treated statistically using the moving average interpolation method of Weil (1952) for LD50 and 95 % confidence limits determinations.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 231 mg/kg bw
- 95% CL:
- ca. 910 - 1 665
- Mortality:
- 500 mg/kg: 0 dead/5 alive
1000 mg/kg: 1/5
2000 mg/kg: 5/5
4000 mg/kg: 5/5 - Clinical signs:
- other: no data
- Gross pathology:
- no data
- Other findings:
- no data
- Interpretation of results:
- other: Category 4
- Remarks:
- EU GHS criteria
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- Acute oral toxicity for N-phenyl-1-napthylamine, administered by gavage to young adult albino rats, was estimated.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data given.
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- No data given.
- Doses:
- 200 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, pathological examinations - Statistics:
- no data
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 000 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 200 - < 2 000 mg/kg bw
- Mortality:
- 2000 mg/kg bw group:
Males: 1/3
Females: 3/3 - Clinical signs:
- other: Dyspnea, exophthalmos, ruffled fur, and abnormal body position were seen (being common symptoms in acute toxicity testings). Additionally, markedly reduced spontaneous activity was observed in the animals of the 2000 mg/kg bw dose group, in which one fema
- Gross pathology:
- No deviations from normal morphology were found in the animals of the 200 mg/kg bw dose group.
The spontaneous dead animals of the 2000 mg/kg bw dose group showed a dilated stomach, one male and one female had a spotted thymus. - Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- Standard Test Procedure: Compound administered by stomach intubation to Wistar derived male rats.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: own colony
- Age at study initiation: 3 to 4 weeks
- Weight at study initiation: 90-120 g
- Fasting period before study: nonfasted
- Diet (ad libitum): appropriate Rockland diet except during period of manipulation or confinement
- Water (ad libitum)
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- 1 ml test material = 100 mg in corn oil
- Doses:
- 1000, 2000 and 4000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology - Statistics:
- no data
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 380 mg/kg bw
- Mortality:
- 4000 mg/kg: 5 dead/ 5 dosed; all animals died 1 day after intubation
2000 mg/kg: 1/5; animal died 1 day after intubation
1000 mg/kg: 1/5; animal died 9 days after intubation - Clinical signs:
- other: 4000 mg/kg: sluggish, unsteady gait for 1 hour, prostrate for 4 hours 2000 mg/kg: appeared normal 1000 mg/kg: appeared normal
- Gross pathology:
- livers mottled; stomachs transparent, free blood; kidneys and adrenals congested; intestines injected, free blood and distended
- Other findings:
- no data
- Interpretation of results:
- other: EU GHS criteria not met
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 625 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- The study was designed to evaluate the acute dermal toxicity of N-phenyl-α-naphthylamine in rabbits.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- other: albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 3 to 5 months - Type of coverage:
- occlusive
- Vehicle:
- carbowaxe
- Remarks:
- PEG 400
- Details on dermal exposure:
- TEST SITE
- Area of exposure: trunk
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): maximum dose that can be retained is 20 mL/kg - Duration of exposure:
- 24 hours
- Doses:
- 2000 and 8000 mg/kg bw
- No. of animals per sex per dose:
- 8000 mg/kg bw: 5 animals
2000 mg/kg bw: 2 animals - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: no data
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- 8000 mg/kg bw group: one animal died on day 8
- Clinical signs:
- other: 8000 mg/kg bw group: Urine brown - similar in colour to chemical sample. Also erythema were observed
- Gross pathology:
- Livers congested and mottled; spleens dark; kidneys khaki brown in colour.
- Other findings:
- no data
- Interpretation of results:
- other: EU GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Additional information
Acute toxicity: oral
The acute oral toxicity of N-phenyl-1-naphthylamine was tested according to standard protocols. The LD50s for rats and mice resulted in values of 1625 mg/kg bw and of 1231 mg/kg bw, respectively (MacEwen and Vernot, 1974). No specific signs of toxicity were reported. Similar results were obtained in supporting studies.
Acute toxicity: dermal
The acute dermal toxicity was evaluated in a study, where 2000 mg/kg bw of N-phenyl-1 -napthylamine in Carbowax PEG 400 was applied to the trunk of 2 male albino rabbits for 24 hours, while 8000 mg/kg bw was applied to 8 animals (Weil, 1974). Since only brown urine was noted and 1 animal of the high dose group died, the authors concluded that the LD50 was >5000 mg/kg bw. Pathological examination revealed congested and mottled liver, dark spleen, and brown kidneys.
Acute toxicity: other routes
After a single intraperitoneal administration of 1 mM/kg bw N-phenyl-1-naphthylamine (Nomura, 1977) a slightly increase in methaemoglobin level (4.1%) was noted within 10 min after administration and was elevated up to 7 % (150 min after administration). A significant methaemoglobin formation was still detectable up to 24 hours after administration. Mice are less sensitive than humans to methaemoglobin induction, and this small increase in methaemoglobin level may be of importance to human health.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No 1272/2008. Based on the data, classification for acute toxicity by the oral route with Category 4 is warranted under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/218.
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