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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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 minor deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
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:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Species: rabbits, 3 females
Strain: Chbb:NZW (New Zealand White)
Age on day of application: approximately 4 - 5 months
Body weight range: 3.0 – 3.3 kg (day of application)
Supplier: Biological Laboratory Service of Boehringer Ingelheim Pharma GmbH & Co. KG
Conditions in the animal room were standardized:
Room number: both, housing and application in room 40 (building N81)
Temperature: 22 ± 2°C
Relative humidity: 45 - 75%
Light/darkness cycle: 12/12 h, with light cycle from 6.00 h to 18.00 h
Average illumination: approximately 60 lx (depending on cage position), which can
be increased to 450 lx during working time.
Air circulation: approximately 10 air changes per hour.
Dry food (Kliba No. 3413.0.25, Provimi Kliba SA, CH-4303 Kaiseraugst, Switzerland) and
municipal drinking water were supplied ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- The test item was mixed with the smallest amount of demineralized water as vehicle to achieve a paste. Approximately 0.5 g of
this test item mixture was administered per skin site. - Number of animals:
- 3 Female
- Details on study design:
- Based on current German law (Chemikaliengesetz [Chemicals Act] 2002), this study was designed to evaluate the dermal tolerance of BIBR 1048 ABA subsequent to topical application in rabbits. It was performed according to OECD Guideline 404 (Acute Dermal Irritation/Corrosion) and in accordance with the principles of Good Laboratory Practice, as described by the respective OECD Guidelines and current German law (Chemikaliengesetz 2002).
According to the test strategy described in OECD Guideline 404, only one animal was treated initially (Group 1, initial test). Sequentially, the test item was administered to three skin sites for 3 min (area 1), 1 h (area 2), and 4 h (area 3), respectively. Administration to the next skin area was only
performed in the absence of serious skin alterations in the previous one. When no serious skin alterations occurred subsequent to 4 h of exposure
on the first rabbit, the test item was administered to two more animals (Group 2, confirmatory test) on the following day for 4 h at a single site only.
Treated skin sites were examined immediately after the end of exposure, as well as 1 h, 24 h, 48 h, and 72 h thereafter. They were evaluated according to the criteria given in OECD Guideline 404 on the latter 4 time points.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1-72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable, no signs observed
- Irritant / corrosive response data:
- No alterations of the rabbits' general appearance was observed subsequent to local administration of the test item. In addition, no skin reaction
beyond the area of exposure were observed and administration of BIBR 1048 ABA did not result in any effect on body weight development.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present study, BIBR 1048 ABA was well tolerated subsequent to topical application on rabbit skin.
There were no macroscopic signs of irritation or corrosion. In addition, there were no signs of systemic side effects or of skin
alterations beyond the area of exposure. Thus, according to the Globally Harmonized Hazard Classification and Labeling
Scheme (GHS), the test item BIBR 1048 ABA is not classified.
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.
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