Isobutyl 4-chloro-3,5-diaminobenzoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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 applied orally

GLP compliance:

no

Remarks:

study conducted prior to GLP implementation

Test type:

standard acute method

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:

other: rats and cats

Strain:

other: Wistar-II-rats and non-pedigree cats

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 (rats), 2.5-3.3 kg (cats)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

Lutrol

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 0.5 mL per 100 g

MAXIMUM DOSE VOLUME APPLIED: 0.5 mL per 100 g

Doses:

100, 250, 500, 1000, 2500 mg/kg (rats)
500 mg/kg (cats)

No. of animals per sex per dose:

15 (rats)
2 (cats)

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

Remarks:

for rats

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable

Remarks:

no animal died

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD0

Remarks:

for rats

Effect level:

>= 2 500 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable

Remarks:

no animal died

Effect levels 3

Sex:

male

Dose descriptor:

LD50

Remarks:

for cats

Effect level:

> 500 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable

Remarks:

no animal died

Effect levels 4

Sex:

male

Dose descriptor:

LD0

Remarks:

for cats

Effect level:

>= 500 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable

Remarks:

no animal died

Mortality:

none observed

Clinical signs:

In rats, a transient (within 0.5h after gavage) impairment of the general condition was seen. In cats, this effect lasted 2 or 3 days.

Other findings:

- Other observations: Blood examination in cats 3, 5, and 24h after gavage revealed normal methemoglobin values.

Applicant's summary and conclusion

Interpretation of results:

other: EU-GHS criteria not met

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 and > / ≥ 500 mg/kg in cats. Hence, the value of 2500 mg/kg is above the limit value for classification according to Regulation 1272/2008 (2000 mg/kg). Hence, the substance does not need to be classified as acutely toxic.

Executive summary:

The test item was applied by gavage to male rats (15/dose) at doses of 100, 250, 500, 1000, 2500 mg/kg and 2 male cats at a dose of 500 mg/kg. In rats, a transient (within 0.5h after gavage) impairment of the general condition was seen. In cats, this effect lasted 2 or 3 days. No mortality was observed. The LD50/0 was determined to be > / ≥ 2500 mg/kg in rats and > / ≥ 500 mg/kg in cats.