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EC number: 230-258-1 | CAS number: 6992-11-6
- 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:
- From 06 MAR 2012 to 27 MAR 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 423) and according to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 4-[(2,5-dichlorophenyl)azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxynaphthalene-2-carboxamide
- EC Number:
- 230-258-1
- EC Name:
- 4-[(2,5-dichlorophenyl)azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxynaphthalene-2-carboxamide
- Cas Number:
- 6992-11-6
- Molecular formula:
- C24H15Cl2N5O3
- IUPAC Name:
- 4-[(1E)-2-(2,5-dichlorophenyl)diazen-1-yl]-3-hydroxy-N-(2-oxo-2,3-dihydro-1H-1,3-benzodiazol-5-yl)naphthalene-2-carboxamide
- Test material form:
- solid: nanoform, no surface treatment
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 9-11 weeks
- Weight at study initiation: 150-174 g
- Fasting period before study: 16-19 h
- Housing: in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 110811)
- Diet: Altromin 1324 maintenance diet for rats and mice (lot no. 0815), ad libitum
- Water: tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals), ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/-10
- Air changes (per hr): 10 x
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- cotton seed oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL / kg bw
- Justification for choice of vehicle: The vehivle was chosen due to its non-toxic characteristics
- Lot/batch no. (if required): MKBG0088V
MAXIMUM DOSE VOLUME APPLIED: 10 mL / kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: highest required dose tested. - Doses:
- The starting dose was selected to be 2000 mg/kg bw. No compound-related mortality was recorded for any animal of step 1 or 2. Based on these results and according to the acute toxic class method regime no further testing was required.
- No. of animals per sex per dose:
- 3 females per step / 2 steps performed
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed on day 1 (prior to administratin) and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- no
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no animal died during the 14-day observation period
- Mortality:
- All animals survived until the end of the study.
- Clinical signs:
- other: None of the animals showed any sign of toxicity.
- Gross pathology:
- With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal.
Any other information on results incl. tables
Table: Body Weight Development - Absolute Body Weights in g and Body Weight Gain in %
Animal No. / |
g |
g |
g |
% |
Step 1 (2000 mg/kg Body Weight) |
||||
1 / female |
166 |
192 |
193 |
16 |
2 / female |
174 |
189 |
203 |
17 |
3 / female |
150 |
167 |
170 |
13 |
Step 2 (2000 mg/kg Body Weight) |
||||
4 / female |
156 |
179 |
184 |
18 |
5 / female |
170 |
194 |
200 |
18 |
6 / female |
166 |
183 |
194 |
17 |
Table: LD50 Cut-Off
Dose |
Number of |
Number of Intercurrent Deaths |
LD50 Cut-Off |
2000 mg/kg bw |
6 |
0 |
unclassified |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, a single oral application of the test item to female rats at a dose of 2000 mg/kg body weight was associated with no sign of toxicity or mortality. The LD50 for female rats is > 2000 mg/kg body weight
- Executive summary:
Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was suspended in cotton seed oil at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg.
All animals used in the study were allowed to acclimatise to the laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs. All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
Table1: Results per Step
Step
Sex/No.
Dose (mg/kg)
Number of Animals
Number of Intercurrent Deaths
1
female/1-3
2000
3
0
2
female/4-6
2000
3
0
All animals survived until the end of the study without showing any signs of toxicity.
Throughout the 14-day observation period, the body weight gain of the test animals was within the normal range of variation for this strain.
At necropsy, no macroscopic findings were observed in any animal of any step. The LD50 for rats is > 2000 mg/kg body weight
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