1,2-Ethanediamine, N1-[(6-chloro-3-pyridinyl)methyl]-

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according OEDC/EU guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)

GLP compliance:

yes (incl. QA statement)

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(2-aminoethyl)[(6-chloropyridin-3-yl)methyl]amine

EC Number:

600-261-6

Cas Number:

101990-44-7

Molecular formula:

C8H12ClN3

IUPAC Name:

(2-aminoethyl)[(6-chloropyridin-3-yl)methyl]amine

Test animals

Species:

rat

Strain:

Fischer 344/DuCrj

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Results and discussion

Effect levels

Dose descriptor:

NOEL

Effect level:

20 mg/kg bw/day (nominal)

Sex:

male/female

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Executive summary:

Twenty-eight-day repeated dose toxicity test and fourteen-day recovery test in each dose group of 6 male and 6 female Fischer

strain ( F344 : DuCrj; 6 weeks old ) rats were conducted with test substance, NTN43412.

Four test groups consist of 3 dose groups at the highest dose level of 500mg/kg, lOOmg/kg and 20mg/kg and one control group,

and the recovery groups of the control group and 500mg/kg group.

The test results are summarized hereinafter.

1. No death due to toxicity of the test substance was observed throughout the study period. In the males and females in

500mg/kg group, acute poisoning symptoms such as salivation and lacrimation were occasionally found.

2. The body weight and body weight gain of the male and female 500mg/kg group were decreased, being accompanied by the

reduced food consumption during the administration period. But, they showed relatively a rapid recovery after the

administration period.

3. In the urinary examination at the end of administration period, the increase of urine volume, urinary pH and higher incidence

with protein positive cases were observed in the males and females in 500mg/kg group. And, urine volume was increased

even in females in lOOmg/kg group. But, these findings disappeared at the end of recovery period.

4. The hematological and blood chemical examinations showed no special findings.

5. The autopsy performed at the end of the administration period revealed the change of lobular pattern in the liver surface

and immature seminal vesicle gland with high incidence in the males in 500mg/kg group. The same findings were observed each

in one rat even at the dose level of lOOmg/kg dose group. But, these findings almost disappeared in the autopsy performed

at the end of the recovery period.

6. In the organ weight, increased kidney relative weight was observed in the males and females in 500mg/kg group at

the end of administration period. A slight increase of kidney relative weight was found in the females even at the end of

the recovery period. No special changes were seen in any other organ weights.

7. In the histopathological examination performed at the end of administration period, centrilobular hepatocyte swelling

was found with high incidence in the males and females in receiving 500mg/kg group. This finding disappeared at the

end of recovery period. No changes due to the test substance were seen in any other organs and tissues.

From the above mentioned results, no effect level ( NOEL ) in this study was estimated at 20mg/kg in the male and female rats.