4H-3,1-benzoxazine-2,4(1H)-dione

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

other information

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data are given

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Principles of method if other than guideline:

internal standard procedure

GLP compliance:

no

Remarks:

pre-GLP study

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4H-3,1-benzoxazine-2,4(1H)-dione

EC Number:

204-255-0

EC Name:

4H-3,1-benzoxazine-2,4(1H)-dione

Cas Number:

118-48-9

Molecular formula:

C8H5NO3

IUPAC Name:

4H-3,1-benzoxazine-2,4(1H)-dione

Details on test material:

Isatoic anhydride, technical grade; no further data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Kirchborchen
- Age at study initiation: no data
- Weight at study initiation: 160 - 210 g
- Fasting period before study: no data
No further data

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Administration / exposure

Type of coverage:

open

Vehicle:

other: acetone /oil (1:10)

Details on dermal exposure:

Five male rats were used. The dorsal skin was shaved. One day later, a 25% solution of the test substance in an acetone / oil vehicle (1:10) was applied to the skin at a dose level of 500 mg/kg bw. A paper collar was used for each animals to prevent them from licking off the applied material. The test material was kept in contact with the skin for 7 days.

Duration of exposure:

7 days

Doses:

500 mg/kg bw

No. of animals per sex per dose:

5 males

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs

Statistics:

LD50 was calculated in accordance with Litchfield and Wilcoxon (1949). J Pharm Exp Ther 96: 99.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 500 mg/kg bw

Mortality:

No deaths occurred.

Clinical signs:

other: No clinical signs of toxicity were noted.

Gross pathology:

no data

Applicant's summary and conclusion

Executive summary:

A 25% solution of the test substance in an acetone / oil vehicle (1:10) was applied to the shaved dorsal skin of each of 5 male Wistar rats a dose level of 500 mg/kg bw. A paper collar was used for each animals to prevent licking of the applied material. The test article was kept in contact with the skin for 7 days. No deaths and no signs of intoxication were observed. LD50 was found to be > 500 mg/kg bw.