Isobutyl 4-chloro-3,5-diaminobenzoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 substance was applied as solution onto the shaved backs of rats.

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:

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

Type of coverage:

not specified

Vehicle:

polyethylene glycol

Remarks:

Lutrol

Details on dermal exposure:

TEST SITE
- Area of exposure: skin of the back

REMOVAL OF TEST SUBSTANCE
Test item was not removed for 7 days.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg/kg
- Concentration (if solution): 25%
- Constant volume or concentration used: yes

VEHICLE
Lutrol

Duration of exposure:

7 days

Doses:

500 mg/kg

No. of animals per sex per dose:

5 males

Control animals:

no

Details on study design:

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

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD0

Effect level:

>= 500 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks:

no indication of skin irritation or any signs of toxicity at the highest dose tested, 500 mg/kg

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 500 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks:

no indication of skin irritation or any signs of toxicity at the highest dose tested, 500 mg/kg

Mortality:

none observed

Clinical signs:

no signs of toxicity observed

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

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. During all experiments, no adverse effects, no signs of toxicity or irritation of mucosa of eyes or nose were observed. So, the determined LD0 / LD50 was ≥ / > 500mg/kg. However, as those values are not above the limit values for classification according to Regulation 1272/2008, and no indication of an LC50 is given, the study cannot be used for classification, may however give the indication that the substance is not highly toxic upon dermal exposure.

Executive summary:

The test item was applied dermally as 25% solution in Lutrol at a dose of 500 mg/kg to the shaved back of 5 male Wistar rats. Exposure was 7 days, 14 days post-observation. No deaths occurred, no signs of toxicity or irritation were noted, the determined LD0 / LD50 was ≥ / > 500mg/kg.