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EC number: 250-830-4 | CAS number: 31837-42-0
- 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
- Study period:
- From19 MAY 2011 to 20 JUN 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given: comparable to guidelines/standards
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ISO 10993-10:2010
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzoic acid
- EC Number:
- 250-830-4
- EC Name:
- 2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzoic acid
- Cas Number:
- 31837-42-0
- Molecular formula:
- C18H15N5O5
- IUPAC Name:
- 2-({2-oxo-1-[(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)carbamoyl]propyl}diazenyl)benzoic acid
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:DNA Rabbitry, Elk River, MN, CANADA
- Age at study initiation: young adults
- Weight at study initiation: 2.2 to 2.3 kg
- Housing: individually housed in suspended stainless steel caging
- Diet: certified commercial animal feed
- Water: potable water from the St. Paul municipal water supply
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- environmental conditions in the animal rooms were maintained according to WuXiAppTec SOP:ILS-0018. The temperature and photoperiod were set to meed the Assessment and Accreditation of Laboratory Animal Care (AAALAC) International recommendations for these species
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 x 0.5 g/animal (i.e.: 0.5 g/patch) wetted with tap water - Duration of treatment / exposure:
- 24 h
- Observation period:
- 1, 24, 48 and 72 h after end of exposure
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 1x1 inch, one patch with test material and one control patch was applied on each side of the vertebral column, i.e. two patches with test material were applied to each animals back
- Type of wrap if used: elastic bandage and hypoallergenic tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with diluted alcohol, slightly swab
- Time after start of exposure: 24 hours (directly after unwrapping )
SCORING SYSTEM: erythema and edema scoring according to Draize system (cf OECD 404)
CALCULATION OF MEAN SCORES: the mean of the 24, 48 and 72 h readings from two patches (i.e. mean of 6 readings / animal) was calculated for each animal
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: animal treated at two sides
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: animal treated at two sides
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable since no effects
- Remarks on result:
- other: animal treated at two sides
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable since no effects
- Remarks on result:
- other: animals treated at two sides
- Irritant / corrosive response data:
- Animal #1 showed a very slight erythema (score = 1) 24 hours after patch removal on the right side of the back, which was gone at the 48 hours reading. At the 48 Hour reading there was a very slight erythema on the left side, which was gone at the 72 hour reading.
Animal #2 showed a very slight erythema 24 hours after patch removal on one side of the back (Score = 1), which was gone at the 48 h reading.
Animal #3 showed no reaction at any reading (erythema and edema score 0).
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the applied test conditions the tes titem did not show any remarkable irritation potential onto the skin of rabbits.
- Executive summary:
- The primary skin irritation potential of the test item was investigated according to ISO 10993 -10:2010. The test item (0.5 g wetted with tap water) was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for 24 hours (one patch with test material on each side of the vertebral column). The scoring of the skin reactions was performed 1, 24, 48 and 72 hours after removal of the test item. The mean score of the 24, 48 and 72 h readings from two patches was calculated for each animal. No edema was observed at any time point (score 0) and only very slight erythema were seen in two animals (score 1) which were reversible after 72 hours at the latest. There was no indication of systemic toxicity.
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