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Diss Factsheets
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EC number: 474-080-4 | CAS number: -
- 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:
- 20.1. 2020 – 5.2. 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 474-080-4
- EC Name:
- -
- Cas Number:
- 76801-93-9
- Molecular formula:
- C14H18I3N3O6
- IUPAC Name:
- 5-amino-N1,N3-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide
- Reference substance name:
- Unknown impurities
- Molecular formula:
- Not available
- IUPAC Name:
- Unknown impurities
- Test material form:
- solid
Constituent 1
impurity 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 00104016
- Expiration date of the lot/batch: 12/2020
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Store in cool place. Keep container tightly closed in a dry and well-ventilated place.
- Stability under test conditions: Stable
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SPF breeding, VELAZ s.r.o., Lysolajské údolí 15/53, 165 00 Prague 6, Czech Republic, RČH CZ 11760500
- Females (if applicable) nulliparous and non-pregnant: yes
- Weight at study initiation: 160-224 g
- Fasting period before study: 20 hrs
- Housing: three animals per cage
- Diet (e.g. ad libitum): Pelleted standard diet for experimental animals ad libitum (Brand - Altromin International)
- Water (e.g. ad libitum): Drinking tap water
- Acclimation period: 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Room temperature 22 ± 3 C, permanently monitored
- Humidity (%): Relative humidity 30 – 70 %, permanently monitored
- Photoperiod (hrs dark / hrs light): Light: 12 hours light/dark cycle: 6am-6pm/6pm-6am
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Lot/batch no. (if required): Olivae oleum raffinatum, Batch No.: 8003998001, Expiration date: 01/2020, Supplier: Dr. Kulich Pharma, s.r.o. Hradec Králové, Czech Republic
MAXIMUM DOSE VOLUME APPLIED: 1 mL/100 g of animal body weight
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The dose level of 300 mg/kg of body weight was used as the starting dose, according to the test guideline, because there is no information about toxicity. - Doses:
- 300 mg/kg bw (group 1) and 2000 mg/kg bw (group 2 and 3)
- No. of animals per sex per dose:
- 3 females per group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Body weight: before application, 8th day and before euthanasia of animals
- Mortality: daily
- Clinical examination: daily
After application the animals were observed individually:
- the first day: twice (30 minutes and 3 hours after application)
- the second day: twice (in the morning and in the afternoon) and daily thereafter for 14 days.
Observations included changes in skin and fur, eyes, visible mucous membranes, behaviour of animals, somatomotor activity, reactions to stimuli, and presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system.
- Pathological examination: 15th day
- Necropsy of survivors performed: yes
- Testing schedule: START: 300 mg/kg bw - 3 females (Step No. 1) - no deaths ► 2000 mg/kg bw – 3 females (Step No. 2) – no deaths ►2000 mg/kg bw - 3 females (Step No. 3) - no deaths ► END of study.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Clinical signs:
- No clinical signs of intoxication were observed in all 3 females at the dose 300 mg/kg (group No. 1) during the clinical observation after the application.
No clinical signs of intoxication were observed in all 6 females at the dose 2000 mg/kg (group No. 2 and No. 3) during the clinical observation after the application. - Body weight:
- Weight increments in groups No. 1, 2 and 3 were adequate to species, sex and age of animals in experiment.
- Gross pathology:
- No pathological macroscopic changes were diagnosed during pathological examination of animals at the dose 300 mg/kg in group No. 1.
No pathological macroscopic changes were diagnosed during pathological examination of animals at the dose 2000 mg/kg in group No. 2 and No. 3.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item toxicity was evaluated on the basis of mortality, clinical signs of intoxication, body weight increments during the observation period and necropsy findings at the end of study.
The test item administered at the doses of 300 and 2000 mg/kg of body weight caused no death of any animal. No serious clinical signs of intoxication were detected at these doses during the whole study. Weight increments were adequate to species, sex and age of animals in experiment. No pathological macroscopic changes were diagnosed during the pathological examination.
According to the study results, the LD50 value of the test item, ATIBA-A, for female rats is higher than 2000 mg/kg of body weight. - Executive summary:
The aim of the study was to investigate acute toxic effects of the test item ATIBA-A, after a single oral administration to Wistar Han rats.
The testing was performed according Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
The test item was administered in a single dose as a suspension in olive oil, given orally via gavage to female Wistar rats. The volume of administered suspension was 1 ml/100 g body weight of animals.
The dosing was performed sequentially in three groups of three females: Group No. 1 (the first step) using the starting dose of 300 mg/kg of body weight, this dose caused no death of animals. Therefore the dose of 2000 mg/kg of body weight was applied to another three animals (Group No. 2) in the second step. Afterwards the dose of 2000 mg/kg of body weight was applied for confirmation to another three animals (Group No. 3) in the third step.
The test item administered at the dose of 2000 mg/kg of body weight caused no death of all 6 females in group No. 2 and No. 3. No clinical signs of intoxication were detected during the whole study in 6 animals. No pathological macroscopic changes were diagnosed during pathological examination.
According to the study results, the LD50 value of the test item, ATIBA-A, for female rats is higher than 2000 mg/ kg of body weight.
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