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: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

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:

This acute dust inhalation toxicity study was conducted wherein a group of ten albino rats was exposed to a dust of the test item for four hours in a 70 -liter inhalation chamber. The average analytical concentration was 1.05 mg/L air. After exposure, the test animals were observed for 14 days.

GLP compliance:

no

Test type:

other: not available

Limit test:

yes

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:

not specified

Details on test animals or test system and environmental conditions:

10 albino rats were used.

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

not specified

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION

- Exposure chamber volume: 70-liter inhalation chamber

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

4 h

Concentrations:

1.05 mg/L air

No. of animals per sex per dose:

10 albino rats

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LC50

Effect level:

> 1.05 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

There were no death during the inhalation exposure or observation period.

Clinical signs:

other: Untoward bahavioral reactions exhibited by the rats included hypoactivity, lacrimation and conjunctivitis.

Body weight:

Body weight gains of nine out of ten rats were normal.

Gross pathology:

Necropsy examinations, performed on all rats at the termination of the two weeks observation period revealed two test rats with tan nodules on all lobes of the lungs. All other finding in the test animals were essentially the same as in stock animals taken from the same group as the test rats.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LC50 is greater than 1.05 mg/L air in rats.

Executive summary:

An acute dust inhalation toxicity study was conducted wherein a group of ten albino rats was exposed to a dust of the test material for four hours in a 70 -liter inhalation chamber. The avrage analytical concentration was 1.05 mg/L air. After exposure, the test animals were observed for 14 days.

Untoward behavioral reactions exhibited by the test animals during exposure included lacrimation, hypoactivity and conjunctivitis. No deaths were noted during the exposure or the two-week observation period. Body weight gains were normal except for one rat.