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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study reported in Japanese with a summary in English, but no data available concerning the year of performance or reporting.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 99.4%

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
Test animals: Rats were used in the test at age of 6 weeks, bodyweights at time of administration, males: 143-162 g, females: 110-133 g.
Test conditions: temperature 23 ± 2 ° c, humidity 55 ± 10%, ventilation 20 times / hour, light 150 to 300 lux, lighting hours 12 hours (am 7: lit, pm 7: off), automatic flush type breeding machine (Ltd. Tokyo Motor Service), stainless steel mesh rearing cage housing 5 animals, breeding cage and supercharging feeding machine replaced once a week, solid feed MF (Oriental yeast co., Ltd. ), food and tap water ad libitum.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
A predetermined amount of test substance dissolved in corn oil (Nacalai Tesque Ltd.).
Solution concentrations: 512, 640, 800, 1000 and 1250 mg / kg per rat, each 10.2, 8.0, 16.0, 20.0 and 25.0% w/v in corn oil.
Animals 16 hours fasted before start of the administration.
Administration: test substance solution dosed for 4 hours using an injection pump via a probe in the stomach at 0.5 ml per 100 g bw.
Doses:
Prior to the main study, three rats of each sex were administered doses of 500, 1000 and 2000 mg/kg bw
Main study: 512, 640, 800, 1000, 1250 mg/kg bw.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Observations:
Symptoms of poisoning and death: during exposure, after 1 hour and thereafter twice daily (AM and PM, holidays only at AM) conducted over 14 days.
Body weights: before the start of dosing and 7 and 14 days after exposure or when an animal was found dead.
Gross pathology: performed on rats that died during the observation period and on survivors after ether anesthesia at the end of the observation period. Gross organ abnormalities were observed and recorded.
Histopathology: A part of the organs were stored in 10% neutral buffered formalin solution for selective subjection to histopathological examination.


Statistics:
Calculation of the LD50 value and its 95% confidence limits after 14 days based on the method of Litchfield-Wilcoxon (1949)

Results and discussion

Preliminary study:
For both sexes there were no deaths at 500 mg/kg bw, and 100% mortality at 1000 and 2000 mg/kg bw..
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
782 mg/kg bw
Based on:
test mat.
95% CL:
>= 648 - 945
Sex:
female
Dose descriptor:
LD50
Effect level:
716 mg/kg bw
Based on:
test mat.
95% CL:
>= 638 - 803
Sex:
male/female
Dose descriptor:
LD0
Effect level:
512 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Observed LD0
Mortality:
See table 1.
Clinical signs:
Locomotor activity decreased in many cases; cyanosis and dark urine was observed in dead rats; salivation; prone position; lateral position; decrease of body temperature; muscle spasms.
Body weight:
No significant effects in surviving rats
Gross pathology:
Pleural effusion in cases of death, black dimples on the thymus and the heart, urine retention, red spots on the esophagus, white or red spots on the small intestine and black or red spots on the stomach.

Any other information on results incl. tables

Table 1: Mortality of rats treated orally with N-Methylaniline

Sex

Dose

No. of

Number of deaths at day:

Relative

Dead

(mg/kg bw)

animals

1

2

3

4

5

6

7

14

mortality

%

Male

512

5

0

0

0

0

0

0

0

0

0/5

0

640

5

0

0

1

0

0

0

0

0

1/5

20

800

5

3

0

0

0

0

0

0

0

3/5

60

1000

5

2

1

1

0

0

0

0

0

4/5

80

1250

5

0

5

0

0

0

0

0

0

5/5

100

Female

512

5

0

0

0

0

0

0

0

0

0/5

0

640

5

1

0

0

0

0

0

0

0

1/5

20

800

5

2

2

0

0

0

0

0

0

4/5

80

1000

5

1

4

0

0

0

0

0

0

5/5

100

1250

5

2

3

0

0

0

0

0

0

5/5

100

 

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information: CLP: Category 4
Conclusions:
N-methylaniline showed to induce mortality after a single oral administration of doses at or above 640 mg/kg bw. It should be classified as category 4 for acute toxicity and indicated as harmful if swallowed.