2-butyl-6-(butylamino)-1H-benz[de]isoquinoline-1,3(2H)-dione

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from HPVIS document.

Data source

Reference

Reference Type:

secondary source

Title:

Acute dermal toxicity for CAS 550-77-4

Author:

U.S Environmental Protection agency

Year:

2017

Bibliographic source:

High Production Volume Information System (HPVIS)

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Acute dermal toxicity test was performed for the substance 2-methyl-1H-isoindole-1,3(2H)-dione.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

N-methylphthalimide

EC Number:

208-982-4

EC Name:

N-methylphthalimide

Cas Number:

550-44-7

Molecular formula:

C9H7NO2

IUPAC Name:

2-methyl-1H-isoindole-1,3(2H)-dione

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Not specified

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: not specified
- Type of wrap if used: gauze bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 200 mg/kg and 2000 mg/kg
- Concentration (if solution): no
- Constant volume or concentration used: not specified
- For solids, paste formed: not specified

VEHICLE
- Amount(s) applied (volume or weight with unit): not specified
- Concentration (if solution): not specified
- Lot/batch no. (if required): not specified
- Purity: not specified

Duration of exposure:

24-hour

Doses:

200 mg/kg and 2000 mg/kg

No. of animals per sex per dose:

2

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: no
- Other examinations performed: body weight gain

Statistics:

Not specified

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Neither of the rabbits at either dose level died during the 14-day post-exposure observation period.

Clinical signs:

other: Not specified

Gross pathology:

Not specified

Other findings:

Not specified

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The acute dermal LD50 value of the test substance 2-methyl-1H-isoindole-1,3(2H)-dione is determined to be >2000 mg/kg bw.

Executive summary:

Acute dermal toxicity test was performed for the substance 2-methyl-1H-isoindole-1,3(2H)-dione. Doses of 200 mg/kg and 2000 mg/kg were used.Two New Zealand White rabbits (one male and one female) were used at each of two dosage levels. The rabbits weighed from 2760 to 2952 grams at the start of the study period. Food and water were available ad libitum. Body weights were measured initially and at 14 days after compound application. The hair was removed from the back of each rabbit with an electric clipper. The test substance was applied once only to the back of each rabbit. Two rabbits received 200 mg/kg and two rabbits received 2000 mg/kg of the test substance. The area of application was then wrapped with a gauze bandage and occluded with Saran Wrap. After a 24-hour exposure period, the bandages were removed and the backs were washed with tepid tap water. The rabbits were observed for mortality for a period of 14 days. Neither of the rabbits at either dose level died during the 14-day post-exposure observation period. All four of the rabbits exhibited body weight gains during this time period. Based upon the results obtained, the test substance is considered a non toxic material by the dermal route of administration.