Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 278-575-4 | CAS number: 76918-62-2
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Data source is the English summary of a Japanese study report
Data source
Reference
- Reference Type:
- other: study report summary
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Sodium N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxynaphthalene-2-carboxamidate
- EC Number:
- 278-575-4
- EC Name:
- Sodium N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxynaphthalene-2-carboxamidate
- Cas Number:
- 76918-62-2
- Molecular formula:
- C18H13N3O3.Na
- Details on test material:
- - Name of test material (as cited in study report): Naphtolone sodium salt
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Age at study initiation: 5 weeks
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 days treatment, 14 days recovery (control and high dose group)
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
200 mg/kg/bw
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
40 mg/kg/bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 6 males and 6 females
- Control animals:
- yes
- Details on study design:
- A 28-day repeated oral dose toxicity study of Nathtolone sodium salt followed by a 14-day recovery study was performed in groups of six male and six female Crj:CD(SD) rats at 5 weeks of age. The high dose was set at 1,000 mg/kg, and altogether 3 doses including 200 and 40 mg/kg were employed. Recovery groups were also set for the 1,000 mg/kg and vehicle control groups.
Examinations
- Observations and examinations performed and frequency:
- mortality, clinical signs, body weights and food intakes during dosing period, hematological examinations, urinalyses, organ weights, necropsy and histopathological examinations at termination of the dosing period
- Sacrifice and pathology:
- yes
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- bilirubin was increased in females of the 1,000 mg/kg
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Total bilirubin was increased in females of the 1,000 mg/kg group
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOEL: 200 mg/kg/day
- Executive summary:
A 28-day repeated oral dose toxicity study of Naphtolone sodium salt followed by a 14-day recovery study was performed in groups of six male and six female Crj:CD(SD) rats at 5 weeks of age. The high dose was set at 1,000 mg/kg, and altogether 3 doses including 200 and 40 mg/kg were employed. Recovery groups were also set for the 1,000 mg/kg and vehicle control groups.
No death occurred in all examinations.
No abnormality was noted in clinical signs, body weights and food intakes during dosing period, in hematological examinations, urinalyses, organ weights, necropsy and histopathological examinations at termination of dosing period.
Concerning the blood chemical examinations, there was a dose-relationship. Total bilirubin was increased in females of the 1,000 mg/kg group at termination of dosing period.
No abnormalities were noted in the recovery group.
Based on these results, the NOEL of Naphtolone sodium salt in rats under the present study conditions was estimated to be 200 mg/kg/day.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.