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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
fertility, other
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Study period:
no data
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Significant methodological deficiencies, poorly documented.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Antifertility Effects of Isatoic Anhydride and Derivatives.
Author:
Cutting WC et al.
Year:
1966
Bibliographic source:
Med Pharmacol Exp 15: 7-16.
Reference Type:
review article or handbook
Title:
Toxikologische Bewertung No. 224: N-Carboxyanthranilsäureanhydrid. Issue 02/92
Author:
Anonymous
Year:
1992
Bibliographic source:
Berufsgenossenschaft der Chemischen Industrie, Heidelberg, ISSN 0937-4248.

Materials and methods

Principles of method if other than guideline:
no data
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; no further data

Test animals

Species:
mouse
Strain:
Swiss
Sex:
male/female
Details on test animals or test system and environmental conditions:
no further data

Administration / exposure

Route of administration:
other: oral:feed; changed to injection (not further specified) during the course of the study
Vehicle:
unchanged (no vehicle)
Details on exposure:
no data
Duration of treatment / exposure:
21 or 5 days; see below
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
ca. 2000, 4000 mg/kg bw/d (1, 2% in the diet)
Basis:
nominal in diet
Control animals:
yes, plain diet

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

Isatoic anhydride was tried for antifertility effects in the usual 5-day plan in which the female only was treated. The results are shown in the table below. The right hand column shows the degree of inhibition as compared to controls. Isatoic anhydride appeared to show the most consistent action with a usual decrease in litters of at least 50%. The values given for administration by diet involve treatment of both males and females; those for injection females only. The weight changes indicate a generally slightly greater weight loss during the period of mating in females receiving treatment  compared to untreated controls.

Applicant's summary and conclusion

Executive summary:

Abstract

A number of derivatives of isatoic anhydride, in particular benzoketotriazine, somewhat reduced the number of subsequent litters in female white Swiss mice. When administration was delayed until after mating the effect appeared to be increased, suggesting an effect during tubal transit or implantation. Treatment of males instead of females at intervals up to a month before mating also appeared to reduce subsequent litters slightly. Benzoketotriazine did not upset normal cycling in female mice, nor produce testicular damage detectable histologically 3,5 weeks after administration.