N-1-naphthylaniline

Repeated dose toxicity: other routes

Administrative data

Endpoint:

short-term repeated dose toxicity: other route

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Studies of sulfhemoglobin formation by various drugs (3)

Author:

Nomura, A.

Year:

1977

Bibliographic source:

Nippon Yakurigaku Zasshi. 73(7): 793-802

Materials and methods

Principles of method if other than guideline:

Examination of methemoglobin and sulfhemoglobin formation after consecutive administration of the test substance for three days in mice.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-1-naphthylaniline

EC Number:

201-983-0

EC Name:

N-1-naphthylaniline

Cas Number:

90-30-2

Molecular formula:

C16H13N

IUPAC Name:

N-phenylnaphthalen-1-amine

Details on test material:

- Name of test material (as cited in study report): N-Phenyl-1-naphthylamine (PNA)
- Analytical purity: no data
- Other: Nakarai Chemicals

Test animals

Species:

mouse

Strain:

other: ddY

Sex:

male

Details on test animals or test system and environmental conditions:

Animals: Mice were 6 -7 weeks old, weighing 25 -30 g.
Temperature: 24 ± 2 °C
Humidity: 60 ± 5 %
Food: "F2" from Funabashi Farm

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

test article suspended in CMC

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

not applicable

Frequency of treatment:

once daily for three consecutive days

Doses / concentrations

Dose / conc.:

219 other: mg/kg

No. of animals per sex per dose:

10-15

Control animals:

yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:

HAEMATOLOGY: Yes / No / No data
- Methemoglobin and sulfhemoglobin formation were measured 48 hours after the last administration and compared to the controls.

Statistics:

Statistics: Data were expressed as mean ± standard error * and * *; Significantly different from control (p=0.05 and 0.01)

Results and discussion

Results of examinations

Haematological findings:

effects observed, treatment-related

Description (incidence and severity):

Methemoglobin formation was highly significantly elevated 48 hours after 3 days of consecutive i.p. administrations to mice, whereas sulfhemoglobin values were not different compared to the controls.

Any other information on results incl. tables

Methemoglobin and sulfhemoglobin formation forty-eight hours after consecutive administrations of  N-phenyl-1-naphthylamine for three days to mice

Compound	Dose mM/kg i.p.	MHb		SHb
		g/dl	%	g/dl	%
Control	0	0.07 ± 0.01	0.4 ± 0.1	0	0
N-Phenyl-1-naphthylamine	1.0	0.24 ± 0.02**	1.6 ± 0.2**	0	0