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Diss Factsheets

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

Referenceopen allclose all

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
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
Reference
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
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.