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EC number: 256-050-0 | CAS number: 43035-18-3
- 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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Deviations:
- no
- 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:
- N-(4-chloro-2,5-dimethoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide
- EC Number:
- 226-103-2
- EC Name:
- N-(4-chloro-2,5-dimethoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide
- Cas Number:
- 5280-68-2
- Molecular formula:
- C33H27ClN4O6
- IUPAC Name:
- N-(4-chloro-2,5-dimethoxyphenyl)-3-hydroxy-4-{[2-methoxy-5-(phenylcarbamoyl)phenyl]diazenyl}-2-naphthamide
- Test material form:
- solid: nanoform, no surface treatment
- Details on test material:
- Name of test material (as cited in study report): Repeated dose 28-day oral toxicity study by daily gavage in the rat followed by a 14-day recovery period: Permanent Carmin FB B02
Analytical purity: 96.26%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Crl:WI(Han) (outbred, SPF-Quality)
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: 6 weeks
- Weight range in groups at day 1: males: 170 g - 200 g, females: 135 g - 150 g
- Housing: in groups of 5 in macrolon cages (MIV type, during overnight activity monitoring individual housing in MIII type)
- Diet: Rodent diet (SM R/M-Z from SSNIFF Spezialdiäten GmbH, Soest , Germany), ad libitum
- Water: tap-water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3
- Humidity (%): 30 to 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
- dose formulations were prepared daily within 4 h prior to dosing and were homogenized to a visually acceptable level.
- the test item is stable in dose formulations for up to 96 h.
VEHICLE
- water - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analyses were conducted on a single occasion during the treatment phase on samples as specified below, using a method that has been validated under NOTOX project 488240.
group I: accuracy (middle position of container)
group II: accuracy and homogenicity (top, middle, botton position of container)
group III: accuracy (middle position of container)
group IV: accuracy and homogenicity (top, middle, botton position of container) - Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 250, 1000 mg/kg bw/d
Basis:
actual ingested
- No. of animals per sex per dose:
- - 5 male and 5 female in each dose group
- 5 male and 5 female for recovery groups at dose 0 and 1000 mg/ kg bw/day - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on the results of a 5-days dose range finding study with the test item
- Post-exposure recovery period in satellite groups: the duration of recovery was 14 days - Positive control:
- - none
Examinations
- Observations and examinations performed and frequency:
- MORTALITY/VIABILITY: Yes
- twice daily
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: at least once daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once prior to treatment and at weekly intervals, this was performed outside the home cage in a standard arena.
BODY WEIGHT: Yes, weekly
FOOD CONSUMPTION: yes, weekly
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
HAEMATOLOGY: Yes
- Anaesthetic used for blood collection: Yes (isofluran)
- Animals fasted: Yes
- Parameters checked see below in Hematology
- How many animals: all
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: after 4 weeks and after 6 weeks (the latter only applied for recovery groups)
- Animals fasted: Yes (with a maximum of 20 h before blood collection)
- How many animals: all animals
- Parameters checked see below
URINALYSIS: Yes
- Time schedule for collection of urine: after 4 weeks and after 6 weeks (the latter only applied for recovery groups)
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
- Parameters checked see below
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: during week 4
- Dose groups that were examined: all
- Battery of functions tested: hearing ability, pupillary reflex, static righting reflex, grip strength, motor activity test - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (parameters checked see below)
HISTOPATHOLOGY: Yes (parameters checked see below) - Statistics:
- - If the variables can be assumed to follow a normal distribution, the Dunnett-test based on a pooled variance estimate was applied for the comparison of the treated groups and the control groups for each sex.
- The Steel test was applied instead of the Dunnett-test if the data can not be assumed to follow a normal distribution.
-The Fisher Exact-test was applied fo frequency data.
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 examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- 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:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY:
- no deaths occurred during the test
- red feces were noted in animals treated with the test item and/or between days 1 and 3 of the recovery period.
- one animal showed red staining of the back. probably caused by staining by the test substance.
- overall no clinical observations of toxicological relevance were found
BODY WEIGHT AND WEIGHT GAIN
No toxicologically significant changes in body weight and body weight gain were noted.
CLINICAL LABORATORY INVESTIGATOIONS
- HAEMATOLOGY
- No changes of toxicological relevance were observed in the hematology parameters after the treatment or recovery periods in both males and females.
- Some changes in haematological parameters were noted in individual animals that distinguished treated animals from control animals. These changes were considered to be of no toxicological significance as they occured in the absence of a treatment-related distribution and remained within the range considered normal for rats of this age and strain and/or occurred only at the end of the recovery phase.
- CLINICAL CHEMISTRY
Several clinical biochemistry parameters were changed at a dose level of 1000 mg/kg/day. These changes were slight and within the range considered to be normal. Therefore these changes were not considered to be of toxicological relevance.
No changes of toxicological relevance were noted in the clinical biochemistry parameters after the treatment and the recovery periods.
- URINALYSIS
No changes of toxicological relevance were observed in the urinalysis parameters after the treatment with the test item and the recovery period in both males and females, at any dose level tested.
Some changes were noted in individual animals that distinguished treated animals from control animals. These changes were considered to be of no toxicological significance since no higher potassium level was noted at the end of the treatment period and no corresponding microscopic findings were found, this was considered of no toxicological relevance.
ORGAN WEIGHTS
No toxicologically significant changes were noted in organ weights and organ to body weight ratios.
Some changes were noted in individual animals that distinguished treated animals from control animals. These changes were within the range considered normal for rats of this age and strain. Therefore the results were considered to be of no toxicological significance.
GROSS PATHOLOGY
- reddish content of several parts of the intestinal tract was noted at the end of treatment in all animals at 250 and 1000 mg/kg/day. This was considered to be caused by staining by the test substance and therefore considered to be of no toxicological relevance.
- At the end of recovery greenish soft nodules in the epididymides were noted in two males at the highest concentration. This is a common finding in this strain and is not considered related to treatment.
HISTORICAL CONTROL DATA (if applicable)
- all other microscopic findings were within the range of background pathology encountered in Wistar rats of this age and strain and occurred at similar incidences and severity in both control and treated rats.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no clinical signs; no mortality; body weight development was not impaired; food consumption was not affected; no findings in haematology; urinalysis, gross pathology and histopathology up to highest dose tested
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- There were no changes in clinical appearance, functional observations, body weights, food consumption, clinical laboratory investigations, macroscopic examination, organ weights and microscopic examination that were considered to be an effect of treatment.
From the results presented in this report a No Observed Adverse Effect Level (NOAEL) of 1000 mg/kg/day was established for male and female rats. - Executive summary:
A 28 -day repeated dose toxicity study with the test item administered by gavage to Wistar rats (SPF-bred; 5/sex/dose) was performed according to OECD TG 407. The dose levels for this study were 50, 250 and 1000 mg/kg bw/day. A control group was treated similarly with the vehicle, water, only. The dosing lasted for 28 days and a 14 day recovery group for controls and the high dosage group (1000 mg/kg bw/d) was included. The test item revealed no treatment-related findings. From the results presented in this report a No Observed Adverse Effect Level(NOAEL) for the test item of 1000 mg/kg bw/day was established.
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