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EC number: 664-406-5 | CAS number: 277319-62-7
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP- and Guideline study with no or minor deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 4-amino-N-hydroxybenzene-1-carboximidamide
- EC Number:
- 664-406-5
- Cas Number:
- 277319-62-7
- Molecular formula:
- C7 H9 N3 O
- IUPAC Name:
- 4-amino-N-hydroxybenzene-1-carboximidamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CrlGlxBrlHan:WI (SPF quality)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- According to the revised version of OECD Guideline 423 (Acute Oral Toxicity - Acute Toxic Class Method, October 2000), the rat is the preferred rodent species in acute toxicity testing.
Species, number of animals: 12 rats, 3 males (M) and 9 females (F)
Strain: CrlGlxBrlHan:WI (SPF quality)
Supplier: Charles River Deutschland GmbH, 97633 Sulzfeld,
Germany
Age (Day 1): approximately 8 - 10 weeks
Body weight range (Day 1): males 200 - 228 g, females 124 - 152 g
Housing conditions:
Temperature: 22 ± 2°C
Relative humidity: 45 - 75%
Light/darkness cycle: 12/12 hours
Illumination period: 06:00 h - 18:00 h
Average illumination: approximately 60 lx (depending on the cage position;
during work in the room the intensity is raised to
approximately 450 lx)
Air change: minimum of 10 air changes per hour
Diet and water:
pelleted dry food ad libitum, withdrawn at Day -1
Municipal tap drinking water ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% aqueous hydroxyethylcellulose (Natrosol® 250 HX)
- Doses:
- 100, 200 and 2000 mg/kg. In the absence of prior experience, 100 mg/kg body weight was chosen as the initial dose.
The second dose was selected based on the animals’ response to 100 mg/kg. - No. of animals per sex per dose:
- 100 mg/kg 3 Female
200 mg/kg 3 Female, 3 Male
2000 mg/kg 3 Female - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observations: twice a day
Body weight: Day 1, 2, 8, 15
- Necropsy of survivors performed: yes
- Other examinations performed:
clinical signs:
The health status of the animals was checked at arrival. The overall appearance and behavior of each animal was inspected once or twice daily. On weekends, on non-working days ..., this inspection was performed only once daily. Any abnormality was recorded with regard to onset, duration and, if possible, intensity.
body weight:
The body weight of all animals was recorded manually within 24 h after arrival. These data were used to monitor body weight compliance with
weight ranges defined in the study plan. They are not reported, but filed in the raw data. During the pretest period, the body weight was recorded one day
before administration (Day -1). During the observation period, the body weight of all animals was recorded on Day 1, 2, 8 and 15, respectively.
Pathology: Necropsy was performed on all animals. Rats were anaesthetized by intraperitoneal injection of sodium pentobarbital and exsanguinated via the abdominal aorta. All gross macroscopical changes were recorded.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 200 - <= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 100 mg/kg: No mortality occurred in the three females treated.
200 mg/kg: Female No. 252 was found dead on Day 1 (0.5 h). All three males survived the entire 14-day observation period.
2000 mg/kg: All three female rats treated had to be sacrificed on Day 1 (0.5 h). - Clinical signs:
- other: 100 mg/kg: In all three females treated, piloerection (0.25 h to 7.75 h), reduced motor activity (0.25 h to 5.0 h) and hunched posture (2.25 h only) were observed. Rats returned to normal on Day-2 and no further clinical signs were seen throughout the r
- Gross pathology:
- Macroscopic observations at necropsy:
100 mg/kg
No gross macroscopic alterations were seen at necropsy of the three female rats treated.
200 mg/kg
All males survived the observation period and, except enlarged kidneys in No. 301, no changes were observed at necropsy.
Female No. 252 died on Day 1. Necropsy revealed generalized congestion as well as alterations in the lungs (discoloration),
small intestine (aqueous content), jejunum (hyperemia), spleen (discoloration) and adrenal glands (enlargement). No changes were
observed in the two other female rats which survived the entire study period.
2000 mg/kg
All females had to be sacrificed for reasons of animal welfare on Day 1. At necropsy, alteration in the lungs (discolorations)
and the intestinal tract were noted (discoloration and altered luminal content in the small intestine).
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present study, no mortality was seen in rats subsequent to a single oral administration of BIBR 1048 ABA at 100 mg/kg. At 200 mg/kg, all three males survived, but one out of three females died. Subsequent to 2000 mg/kg, all three females had to be sacrificed.
The approximate lethal dose (ALD) for BIBR 1048 ABA is between 200 mg/kg and 2000 mg/kg for male and female rats.
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