Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
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:
accumulation test in accordance with Lim et al (1961). Arch Int Pharmacodyn 130: 336.
internal standard procedure
GLP compliance:
no
Remarks:
pre-GLP study
Limit test:
no

Test material

Constituent 1
Chemical structure
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
male and female rats (Wistar II SPF)
- Source: Winkelmann, Kirchborchen
- Age at study initiation: no data
- Weight at study initiation: ca. 145 g
No further data

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: acetone / oil (1:10)
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
5 days
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
200 mg/kg bw increasing to 1013 mg/kg bw, see below
Basis:

No. of animals per sex per dose:
30 males
Control animals:
no
Positive control:
no

Examinations

Statistics:
no data

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

No deaths and no clinical signs of toxicity were observed at any time point. 

Applicant's summary and conclusion