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EC number: 202-077-8 | CAS number: 91-56-5
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 March 2015 - 31 March 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test method according to OECD Guideline 420. GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Indoline-2,3-dione
- EC Number:
- 202-077-8
- EC Name:
- Indoline-2,3-dione
- Cas Number:
- 91-56-5
- Molecular formula:
- C8H5NO2
- IUPAC Name:
- 2,3-dihydro-1H-indole-2,3-dione
- Details on test material:
- - Name of test material (as cited in study report): Indoline-2,3-dione
- Physical state: orange, crystalline powder
- Analytical purity: 98.0%
- Lot/batch No.: MP 1076.3
- Storage condition of test material: storage temperature: 5-35ºC.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Experimental Medicine Centre at the Medical University in Białystok
- Age at study initiation: 11 weeks old
- Weight at study initiation: 207.3 g
- Fasting period before study:
- Housing: plastic cages covered with wi re bar lids. The dimensions of the cages were 58 x 37 x 21 cm (length x width x height).
- Diet (e.g. ad libitum): “Murigran” standard granulated laboratory fodder, ad libitum.
- Water (e.g. ad libitum): drinking tap water, ad libitum.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 – 23 °C
- Humidity (%): 40 – 58%
- Air changes (per hr): about 16 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 400 mg/mL
- Amount of vehicle (if gavage): 1 mL
MAXIMUM DOSE VOLUME APPLIED: 0.5 mL/100 g b.w.
- Rationale for the selection of the starting dose: The starting dose for the preliminary experiment was selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg b.w. as a dose expected to produce evident toxicity. Since no data were available, the preliminary experiment started with the administration of the test item at a dose of 300 mg/kg b.w to one female rat. Since no evident toxicity was produced, the test item at a single dose of 2000 mg/kg b.w. was administered to the second animal. The animal treated with the test item at a dose of 2000 mg/kg b.w. survived the experiment. On the grounds of the preliminary experiment results, the dose of 2000 mg/kg b.w. was selected to be used in the main experiment. - Doses:
- Sighting study: 300 and 2000 mg/kg b.w.
Main study: 2000 mg/kg b.w. - No. of animals per sex per dose:
- 2 females in the sighting study.
4+1 (from the preliminary study) females in the main study. - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: body weights were determined on days 0 (directly before the administration of the test item), 7, and 14 (before euthanasia).
- Necropsy of survivors performed: yes.
- Other examinations performed:
General condition: the observation of all animals for morbidity and mortality was conducted twice a day or once a day (on days off) during the 14-day experiment.
Detailed clinical observations: the detailed clinical observations were performed on the day of the test item administration (day 0), i.e. 10, 30, and 60 minutes after the administration and then at hourly intervals up to the 5th hour after the administration. From the 1st to the 14th day of the experiment, the detailed clinical observations were performed once a day.
Gross examinations: After the 14-day observation period, all animals were euthanized by intraperitoneal administration of Morbital at a dose of 200 mg/kg b.w. and subjected to gross examinations. The detailed gross examinations involved the observation of the external body surface, all natural apertures, and the cranial, thoracic, and abdominal cavities with their content.
Results and discussion
- Preliminary study:
- Following single administration of the test item at a dose of 300 mg/kg b.w. to the first animal used in the preliminary experiment, no signs of toxicity were stated. The animal survived the experiment.
Following single administration of the test item at a dose of 2000 mg/kg b.w. to the other animal used in the preliminary experiment, the rounded back, slightly decreased locomotor activity, and dejection were stated on the administration day. The animal survived the experiment.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived the experiment.
- Clinical signs:
- other: The rounded back, slightly decreased locomotor activity, and dejection were stated in all animals on the administration day.
- Gross pathology:
- The animals did not exhibit any pathological changes.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No mortality was observed following single administration of the test item at a dose of 2000 mg/kg bw in rats. The test substance is not classified according to the CLP Regulation (EC) no 1272/2008.
- Executive summary:
The acute oral toxicity study on Wistar rats was performed according to the OECD Guideline 420 and EU Method B.1. bis, following the Principles of GLP. The test item was prepared as an oil suspension in a volume of 0.5 mL/100 b.w. and it was administered with a metal stomach tube. A preliminary experiment started with the administration of 300 mg/kg b.w. of the test item to one animal. Since no evident toxicity was observed, a second animal was dosed at 2000 mg/kg b.w. The animal survived the experiment but presented signs of toxicity: rounded back, slightly decreased locomotor activity, and dejection were stated on the administration day.
In the main experiment 4 animals received 2000 mg/kg b.w of the test item. After the administration of the test item, the animals were observed for 14 days. General and detailed clinical observations were conducted daily during the entire experiment. Body weights of the animals were determined on days 0, 7, and 14. All the animals survived the experiment and were euthanized after the observation period. Gross examinations did not reveal any pathological changes in the examined animals. On the basis of these results, the test substance is not classified according to the CLP Regulation (EC) no 1272/2008.
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