Isobutyl 4-chloro-3,5-diaminobenzoate

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Remarks:

intraperitoneal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1970-09-24 - 1971-07-05

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Usual methods used at the laboratory, as described in the report

Deviations:

not specified

Principles of method if other than guideline:

The test item was injected intraperitoneally in rats.

GLP compliance:

no

Remarks:

study conducted prior to GLP implementation

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isobutyl 4-chloro-3,5-diaminobenzoate

EC Number:

251-311-5

EC Name:

Isobutyl 4-chloro-3,5-diaminobenzoate

Cas Number:

32961-44-7

Molecular formula:

C11H15ClN2O2

IUPAC Name:

2-methylpropyl 3,5-diamino-4-chlorobenzoate

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Wistar-II

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeder Winkelmann, Kirchborchen (rats)
- Weight at study initiation: 160-200 g

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

polyethylene glycol

Remarks:

Lutrol

Details on exposure:

Amount of vehicle: 0.5 mL per 100 g

Doses:

50, 100, 250, 500, 1000, 2500 mg/kg

No. of animals per sex per dose:

15

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable

Remarks:

no mortality occurred

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD0

Effect level:

>= 2 500 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable

Remarks:

no mortality occurred

Mortality:

none observed

Clinical signs:

In rats, a transient (within 5d after gavage) impairment of the general condition was seen, similar to the signs after oral gavage.

Applicant's summary and conclusion

Conclusions:

The study was performed in a scientifically reasonable method with sufficient documentation indicating that the study was well-performed. Hence, there is no doubt that the obtained results are reliable. No mortality was observed. The LD50/0 was determined to be > / ≥ 2500 mg/kg in rats. Although the i.p. route is not relevant for classification, it is indicated that the substance is not very toxic.

Executive summary:

The substance was injected intraperitoneally in Lutrol at doses of 50, 100, 250, 500, 1000, 2500 mg/kg into male Wistar rats (15/dose). A transient (within 5 d after injection) impairment of the general condition was seen. The LD50/0 was determined to be > / ≥ 2500 mg/kg in rats.