Reaction mass of 2-[[[2-[(2-aminoethyl)amino]ethyl]amino]carbonyl]-benzoic acid and 2,2' -[iminobis(2,1-ethanediyliminocarbonyl)]bis-benzoic acid and 7,8,9,10,11,12,20,21,22,23,24,25-dodecahydrodibenzo[i,t] [1,4,7,12,15,18] hexaazacyclodocosine-5,13,18,26(6H,19H)-tetrone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No GLP study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

In this acute oral range finding study, 6 males albino rats were used to performed the expriment. 2 rats for each dose levels were used (1000 / 3000 / 10000 mg/kg). Clinical signs, mortality and body weight were recorded.

GLP compliance:

no

Test type:

other: No data

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-({2-[(2-aminoethyl)amino]ethyl}carbamoyl)benzoic acid; 2-{[2-({2-[(2-carboxyphenyl)formamido]ethyl}amino)ethyl]carbamoyl}benzoic acid; 3,6,9,18,21,24-hexaazatricyclo[24.4.0.0¹¹,¹⁶]triaconta-1(30),11,13,15,26,28-hexaene-2,10,17,25-tetrone

EC Number:

942-764-6

IUPAC Name:

2-({2-[(2-aminoethyl)amino]ethyl}carbamoyl)benzoic acid; 2-{[2-({2-[(2-carboxyphenyl)formamido]ethyl}amino)ethyl]carbamoyl}benzoic acid; 3,6,9,18,21,24-hexaazatricyclo[24.4.0.0¹¹,¹⁶]triaconta-1(30),11,13,15,26,28-hexaene-2,10,17,25-tetrone

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Type of material: powder.

Test animals

Species:

rat

Strain:

other: Albino rats

Sex:

male

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

Form administred: 25.0% (w/v) suspension in corn oil.

Doses:

1000 / 3000 and 10000 mg/kg

No. of animals per sex per dose:

2 males for each dose level.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At test day 0 and test day 14 for the surviving
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.

Statistics:

No data

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 1 000 - < 3 000 mg/kg bw

Based on:

test mat.

Mortality:

- At 1000 mg/kg: 0 percent dead.
- At 3000 mg/kg: 100 percent death after 30 minutes after administration.
- At 10000 mg/kg: 100 percent death (the first one 30 minutes after administartion and 15 minutes after administration for the second)

Clinical signs:

other: - At 1000 mg/kg: Hypoactivity, gasping, pilo-erection. - At 3000 mg/kg: Hypoactivity, gasping, abdominal griping, pilo-erection, convulsions. - At 10000 mg/kg: Hypoactivity, gasping, abdominal griping, pilo-erection, convulsions.

Gross pathology:

Gross pathology finding: Necropsy examination of the animals that died revealed hemorrhaged stomachs. No gross pathologic alterations were noted among the animals sacrified at the end of the 14-day observation period.

Any other information on results incl. tables

Reactions:

Dose (mg/kg)	Reaction	Time of onset following dose administration	Duration of reaction	Time of death following dose administration
1 000	Hypoactivity	5 minutes	6 -22 hours	/
1 000	Gasping	5 minutes	10 minutes	/
1 000	Pilo-erection	5 minutes	6 -22 hours	/
3 000	Hypoactivity	5 minutes	Until death	30 minutes
3 000	Gasping	5 minutes	Until death	30 minutes
3 000	Abdominal griping	5 minutes	Until death	30 minutes
3 000	Pilo-erection	15 minutes	Until death	30 minutes
3 000	Convulsions	15 minutes	Until death	30 minutes
10 000	Hypoactivity	5 minutes	Until death	15 -30 minutes
10 000	Gasping	5 minutes	Until death	15 -30 minutes
10 000	Abdominal griping	5 minutes	Until death	15 -30 minutes
10 000	Pilo-erection	15 minutes	Until death	15 -30 minutes
10 000	Convulsions	15 minutes	Until death	15 -30 minutes

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In the acute oral toxicity experiment, the LD50 was determined to be > 1000 mg/kg <3000 mg/kg.

Executive summary:

In the acute oral range finding study, 6 males albino rats were used.

2 rats for each dose levels were used (1000 / 3000 / 10000 mg/kg).

The test material was suspended in corn oil before administration to the rats.

Mortality

- At 1000 mg/kg: 0 percent dead.

- At 3000 mg/kg: 100 percent death after 30 minutes after administration.

- At 10000 mg/kg: 100 percent death (the first one 30 minutes after administartion and 15 minutes after administration for the second)

Clinical signs:

- At 1000 mg/kg: Hypoactivity, gasping, pilo-erection.

- At 3000 mg/kg: Hypoactivity, gasping, abdominal griping, pilo-erection, convulsions.

- At 10000 mg/kg: Hypoactivity, gasping, abdominal griping, pilo-erection, convulsions.

In conclusion, in the acute oral toxicity experiment, the LD50 was determined to be > 1000 mg/kg <3000 mg/kg.