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EC number: 429-750-0 | CAS number: 180898-37-7
- 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
- Study period:
- 1996-03-18 to 1996-03-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP study reliable with restrictions Deviations from EU method B.4 (2008): - according to the guideline when responses such as scaling persist to the end of the 14-day observation period, the test substance should be considered an irritant. In this study scaling was observed at 72 hours and on day 7 of the study. After day 7 the observation of the animals was terminated. The study should have been continued at least until day 14 in order to see, if the scaling effect was reversible. Since this did not happen the study has limited reliablity for classification of the test material. - in addition to the observation of irritation, all local toxic effects, such as defatting of the skin, and any systemic adverse effects (e.g. effects on clinical signs of toxicity and body weight), should be fully described and recorded. The systemic adverse effects were not recorded in the study report. - the age of the animals and the animal weights at the conclusion of the test were missing in the study report.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- please refer to "Rationale for reliability incl. deficiencies" above
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992-07-17
- Deviations:
- yes
- Remarks:
- Rationale for reliability incl. deficiencies" above
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Data of inspection March 1996
Test material
- Reference substance name:
- -
- EC Number:
- 429-750-0
- EC Name:
- -
- Cas Number:
- 180898-37-7
- Molecular formula:
- C20H12N4O12S4.2Na
- IUPAC Name:
- disodium dihydrogen 2-[4-(5,7-disulfonato-1H-1,3-benzodiazol-2-yl)phenyl]-1H-1,3-benzodiazole-5,7-disulfonate
- Details on test material:
- - CAS name: 1H-Benzimidazole-4,6-disulfonic acid-2,2´-(1,4-diphenylene) bis, disodium salt
- Molecular formula: C20H12N4O12S4Na2
- Molecular weight: 674g/mol
- physical state: solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: stock Mol:Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - SPF albino rabbits
- Source: MØllegaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved
- Weight at study initiation: 2.0 - 2.1 kg
- Housing: during a pre-period of at least one week and throughout the experiment the rabbits were caged individually in PPO/HIPS (Noryl®) cages (floor area: 2576 cm^2) with perforated floor.
- Diet (ad libitum): a pelleted complete rabbit diet "Altromin 2123" from Chr. Petersen, DK-4100 Ringsted
- Water (ad libitum): domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: a per-period of at least one week
ENVIRONMENTAL CONDITIONS
- Temperature: 21°C ± 3°C
- Relative humidity: 55% ± 15%
- Air changes: 10 times/hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 g of HR 96/N0002 moistened with distilled water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours as well as 7 days after termination of exposure
- Number of animals:
- 4 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure and type of wrap used: the day before the experiment was started the rabbits were weighed and an area of 10 X 10 cm on the back was clipped as closely as possible with an electric clipper.
On the experimental day the rabbits were physically restrained on a test table, and the clipped area was divided into four test sites: two anterior located test sites and two posterior located test sites. To each of four gauze patches (2.5 X 2.5 cm) HR 96/N00002 moistened with the vehicle was applied. Indentically 0.5 mL of three other test articles were applied to gauze patches (please refer for results on these three test materials to Section 7.3.1 Skin irritation / corrosion: s_Aarup_1997). The patches were placed on the appropriate test site on the back of each rabbit. The gauze patches were secured with 2.5 cm wide adhesive tape and fixed with Scanpor tape (5 cm width). Thereafter Nobifix (6 cm width) was loosely wound round the trunk. The application schedule of the four test articles are given in the field "Any other information on materials and methods incl. tables" below.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: after the exposure time of 4 hours
- Washing: the tape and patches were removed and the treated skin was cleaned with lukewarm water.
SCORING SYSTEM: according to the Draize scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: However, at the examination 72 hours after termination of exposure the test site of the rabbit showed slight scale formation. On day 7 few scales were still present but the skin of the test site was intact.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: At the examination 72 hours after termination of exposure the test site of the rabbit showed slight scale formation. On day 7 few scales were still present but the skin of the test site was intact.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: However, at the examination 72 hours after termination of exposure the test site of the rabbit showed slight scale formation. On day 7 few scales were still present but the skin of the test site was intact.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: At the examination 72 hours after termination of exposure the test site of the rabbit showed slight scale formation. On day 7 few scales were still present but the skin of the test site was intact.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Note: the results given below refer only to HR 96/N00002. For the results on the other applied test materials please refer to Section 7.3.1 Skin irritation / corrosion: s_Aarup_1997.
One hour after termination of exposure the test sites of the four rabbits showed slight skin erythema (grade 1). During the rest of the observation period slight erythema (grade 1) was observed among two rabbits. No oedema was observed in any of the rabbits.
At the examination 72 hours after termination of exposure the test sites of the four rabbits showed slight scale formation.
On day 7 few scales were still present but the skin of the test sites was intact.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion the test materialis considered to be not irritating to the skin.
According to 67/548/EC and subsequent regulations, the test substance is not classified as a skin irritant.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test substance is not classified as skin irritant. - Executive summary:
According to the outcome of the test, effects observed in 2 of 3 animals on erythema (score ≤1) are fully reversible within 7 days. Hence, no classification is required. However, 72 hours after termination of exposure the test site of the rabbit showed slight scale formation. On day 7 (test end) few scales were still present but the skin of the test site was intact.
According to regulation (EC) 1272/2008:“...inflammation persists to the end of the observation period in 2 or more test animals, taking into consideration alopecia (limited area), hyperkeratosis, hyperplasia and scaling, then a material shall be considered to be an irritant.”Nevertheless, according to the OECD guideline 404 the observation period should be up to 14 days. Since the observation period in this study was chosen to be 7 days only and the fact that only few scales were still present after 7 days but the skin of the test site was already intact, it can safely be assumed that all effects observed would be reversible within 14 days.
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