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EC number: 224-638-6 | CAS number: 4433-79-8
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD and GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 4'-chloro-2',5'-dimethoxyacetoacetanilide
- EC Number:
- 224-638-6
- EC Name:
- 4'-chloro-2',5'-dimethoxyacetoacetanilide
- Cas Number:
- 4433-79-8
- Molecular formula:
- C12H14ClNO4
- IUPAC Name:
- N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutanamide
- Details on test material:
- - Name of test material (as cited in study report): Naphthol AS IRG
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Hoechst AG, Kastengrund, SPF breeding colony
Age: approx 6 weeks
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- once daily, 28 applications within 29 days, 7 days/week
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
4.0 mg / kg bw / d
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
20.0 mg / kg bw / d
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
100.0 mg / kg bw / d
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 female, 5 male
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- Behaviour and state of health were observed daily in all groups. Body weights and food consumption were recorded twice weekly, and water consumption once weekly.
Hematological examinations and clinical chemistry were carried out at the termination of the study. Urine analysis was also performed at the end of the study. - Sacrifice and pathology:
- During necropsy the animals were examined for macroscopically visible abnormalities, the main organs weighed and the organ to body weight ratios calculated. Many organs and tissues were processed for histopathological examination and checked for microscopically visible changes.
- Statistics:
- The following parameters were compared statistically with the control group values at the level of significance p= 0.05:
Body weights at the designated measurement times
Hematological data
Clinical chemistry parameters (except GGT)
Urine analysis (Volume, pH-value and specific weight)
Absolute organ weights and organ to body weight ratios
Results and discussion
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 20 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: The test substance caused no detectable effects at the dose of 20mg/kg body weight per day in male and female Wistar rats when administered 28 times during 29 days.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- With regard to the present study the "no observed effect level" is 20 mg/kg body weight per day in male and female Wistar rats.
- Executive summary:
Groups of 5 male and 5 female Wistar rats received Naphthol AS IRG by oral gavage at dose levels of 0, 4, 20 or 100 mg/kg body weight per day for 28 days and were necropsied at day 29.
Behaviour and state of health were observed daily in all groups. Body weights and food consumption were recorded twice weekly, and water consumption once weekly.
Hematological examinations and clinical chemistry were carried out at the termination of the study. Urine analysis was also performed at the end of the study.
During necropsy the animals were examined for macroscopically visible abnormalities, the main organs weighed and the organ to body weight ratios calculated. Many organs and tissues were processed for histopathological examination and checked for microscopically visible changes.
Body weights, hematological and clinical chemistry data, urine data (volume, pH value, specific weight), absolute and relative organ weights were analysed with the aid of a statistical program to show differences compared with the controls.
Beside unspecific symptoms males and females of the highest dose group showed impairments of motility and breathing from day 1 up to day 9 of the study. Additionally mucous feces was observed in two male animals of the highest dose group at day one of the study. Increased salivation occurred in females of the 100 mg/kg body weight per day group sporadically starting from day 23 of the study. Behaviour and general health condition of the other animals remained normal throughout the study.
Development of body weight was not impaired. Food and water consumption remained unaffected by the treatment during the whole study.
Examination of the urinary status revealed dark yellow discoloration and positive bilirubin indications in both sexes of the high dose group. No compound-related changes were observed in the other groups.
Hematological examinations showed decreases in erythrocyte counts, hemoglobin and hematocrit values in both sexes of the high dose group.
Clinical chemistry investigations showed no compound related effect.
Liver weights were increased in both sexes of the high dose group.
No compound related macroscopically visible changes were observed at necropsy.
The histopathological examinations revealed no compound-related effects.
In conclusion repeated application of 100 mg Naphthol AS IRG per kg body weight caused clinical signs of intoxication in both sexes. Additionally, signs of slight anemia and slight elevations of liver weights were observed in this group. The positive bilirubin indications in the urine could either be due to real bilirubin presence or due to interaction of the test substance or its metabolites with the test stick.
Naphthol AS IRG caused no detectable effects at the dose of 20 mg/kg body weight per day in male and female Wistar rats when administered 28 times during 29 days.
With regard to the present study the "no observed effect level" is 20 mg/kg body weight per day in males and females.
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