Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-255-0 | CAS number: 118-48-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- 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:
- dynamic inhalation in accordance with Niessen et al (1963). Arch Toxicol 20: 44
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/female
- 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:
- inhalation: aerosol
- Type of inhalation exposure:
- not specified
- Vehicle:
- other: DMSO / Lutrol (1:1)
- Remarks on MMAD:
- MMAD / GSD: no data
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: dynamic inhalation system in accordance with Niessen et al (1963). Arch Toxicol. 20: 44.
The aerosol was generated by spraying.
No further data
TEST ATMOSPHERE
- Brief description of analytical method used: spectrophotometry at 316 µM, 10-mm layer of test substance
- Samples taken from breathing zone: no data
VEHICLE (if applicable)
- Justification for use and choice of vehicle: no data
- Composition of vehicle: DMSO / Lutrol (1:9)
No further data. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- spectrometry (319 µm)
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 4 hours per day, 5 days per week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.0116; 0.071 mg/L
Basis:
analytical conc.
- No. of animals per sex per dose:
- 10 males and 10 females per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- no post-exposure
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes, behaviour
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION: No
FOOD EFFICIENCY: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY, CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at the end of the exposure period
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: 5/sex/group
- Parameters examined: hemoglobin, erythrocyte count, leukocyte count, thrombocyte count, hematocrit, HbE value, mean corpuscular volume, prothrombin time, liver function test (GOT, GPT, SDH), kidney function test (serum urea, serum creatinine)
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: No
After termination of exposure, animals were anesthetised and sacrificed by exsanguination. The following organs were weighed and examined macroscopically: thyroid, heart, lungs, liver, spleen, kidneys, adrenals, testes, ovaries - Statistics:
- no data
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No signs of intoxication were observed.
BODY WEIGHT AND WEIGHT GAIN
Body weight gain of treated rats was not statistically significantly different from concurrent vehicle controls.
HAEMATOLOGY, CLINICAL CHEMISTRY
Hematological and clinical-chemical values as well as those for liver function test and kidney function test were within the normal range for all groups.
ORGAN WEIGHTS
Relative liver weights and absolute and relative lung weights were statistically significantly increased in high dose females. However, no information is given whether these changes were considered substance/treatment-related. No other significant changes in organ weights were reported.
GROSS PATHOLOGY
No pathological changes were noted for the organs of treated rats.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 0.012 mg/L air
- Sex:
- male/female
- Basis for effect level:
- other: Increased liver and lung weights in higher doses
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
Groups of 10 male and 10 female Wistar rats were exposed to the test substance at analytical concentrations of 0.0116 and 0.071 mg/L for 4 weeks (4 h/d, 5 d/w). A control group was exposed to the concurrent vehicle, (DMSO/ Lutrol, 1:1). Observations/examinations included behaviour, body weight gain, selected hematological and clinical-chemical parameters, organ weights and gross pathology.
In high dose females, absolute and relative lung weights and relative liver weights were statistically increased. No other changes were noted. A histopathological examination was not carried out.
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.