Registration Dossier
Registration Dossier
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EC number: 204-255-0 | CAS number: 118-48-9
Repeated dose toxicity: oral
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:
- 1 970
- 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
- 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
Constituent 1
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
