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EC number: 228-770-5 | CAS number: 6358-36-7
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral, other
- Remarks:
- Combined repeated dose & carcinogenicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from NTRL report
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Carcinogenicity Study with Calcozine Yellow SFW Unblended In Albino Rats with Cover Letter Dated 052692
- Author:
- US department of Commerce
- Year:
- 1 992
- Bibliographic source:
- National Technical Report library; OTS0539600; B 8723; 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Repeated dose orl toxicity study was performed to determine the toxic nature of Calcozine YeIlow SPF Unblended upon repeated exposure by oral route
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride
- EC Number:
- 228-770-5
- EC Name:
- 4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride
- Cas Number:
- 6358-36-7
- Molecular formula:
- C21H29N3.ClH
- IUPAC Name:
- 4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride
- Details on test material:
- SMILES:CCN(CC)c1ccc(C(c2ccc(N(CC)CC)cc2)=N{+}.Cl{-})cc1
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Calcozine Yellow SFW Unblended
- EC name: 4,4'-carbonimidoylbis(N,N-diethylaniline) hydrochloride
- Molecular formula: C21H29N3ClH
- Molecular weight: 359.942 g/mol
- Substance type: Organic
- Physical state: No data
- Impurities (identity and concentrations): No data
Test animals
- Species:
- rat
- Strain:
- other: Albino
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- oral: feed
- Details on route of administration:
- No data
- Vehicle:
- other:
- Remarks:
- Feed
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Calcozine Yellow SPF was mixed with feed to give a dietary level of 0.1%
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): Feed
- Concentration in vehicle: 50 mg/Kg bw/day
- Amount of vehicle (if gavage): No data
- Lot/batch no. (if required): No data
- Purity: No data - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 20-21 months
- Frequency of treatment:
- No data
Doses / concentrations
- Remarks:
- 0 or 100 mg/Kg bw/day
- No. of animals per sex per dose:
- No data
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- Auramine
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. Mortality
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: No data
BODY WEIGHT: Yes
- Time schedule for examinations: No data
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY: No data
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
CLINICAL CHEMISTRY: No data
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data - Animals fasted: No data - Parameters checked in table [No.?] were examined. No data
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data
OTHER: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- No data
- Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, non-treatment-related
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, non-treatment-related
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Histopathological findings: neoplastic:
- effects observed, non-treatment-related
- Other effects:
- not specified
- Details on results:
- Clinical signs and mortality: Mortality was comparable to or better than that observed in untreated control group
Body weight and weight gain: A less marked reduction in body weight gain was observed in the rats fed Calcozine Yellow SFW Unblended.
Food consumption and compound intake: No data
Food efficiency: No data
Water consumption and compound intake: No data
Opthalmoscopic examination: No data
Haematology: No data
Clinical chemistry: No data
Urinanalysis: No data
Neurobehaviour: No data
Organ weights: No changes were observed in organ weight as compared to untreated control animals.
Gross pathology: Nodules were observed on the livers only 25% (7/28) of the test rats at the time of final sacrifice. No unusual growth was observed in the control rat livers.
No other outstanding differences were noted in any of the groups upon gross pathologic examination.
Histopathology:
Non neoplastic: Significant liver injury was noted among animals from test groups which was attributed to the test materials. The primary lesion consisted of focal to diffuse hyperplasia of the liver cells. Minor focal lesions of degeneration, necrosis , fatty me tamorphosis , inflammation, bile duct proliferation and cholangiofibrosis were present in the liver of treated animals. The lesions noted upon microscopic examination of the other- tissues from test animal group were attributed to naturally occurring disease and were considered to be normal for albino rats of this age and strain.
Neoplastic: Hepatomas were present in 2/9 male and 1/19 female that survived the length of the investigation. There were no hepatomas observed in any of the treated animals that died prior to the conclusion of the study. However, there were no hepatomas observed in any of the test animals that died prior to the conclusion of the investigation.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw (total dose)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant alterations were noted at mentioned dose level
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) for Calcozine YeIlow SPF Unblended is considered to be 100 mg/Kg bw/day.
- Executive summary:
Combined repeated dose & carcinogenicity was performed to determine the toxic nature of Calcozine YeIlow SPF (IUPAC name: 4,4'-carbonimidoylbis (N,N-diethylaniline) hydrochloride) upon repeated exposure by oral route of exposure. Male and female albino rats were fed the test chemical at dose levels of 100 mg/Kg bw/day using diet for 20-21 months. Auramine was used as a positive control chemical. The animals were observed for mortality, body weight changes, gross pathology and neoplastic and non-neoplastic histopathology. Survival observed in the test animals was comparable to that noted in untreated control group. A less marked reduction in body weight gain was observed in the treated rats as compared to controls. Nodules were observed on the livers only 25% (7/28) of the test rats at the time of final sacrifice which was less as compared to the nodules observed in positive control 59% (20 /34). No other outstanding differences were noted in any of the groups upon gross pathologic examination. There was significant liver injury among animals from both the positive' control and test groups which was attributed to the positive control and test materials.The incidence of hyperplasia observed was comparable in positive control and treated animals. Minor focal lesions of degeneration, necrosis , fatty metamorphosis , inflammation, bile duct proliferation and cholangiofibrosis were present in the liver of control, positive control and test animals. However the severity of these Iesions was generally greater in the livers of the positive control animals than in the Iivers of control or test animals. The lesions noted in other tissues upon microscopic examination of the from control, positive control and test animals were attributed to naturally occurring disease and were considered to be normal for albino rats of this age and strain. Hepatomas were present in 2/9 male and 1/19 female that survived the length of the investigation. There were no hepatomas observed in any of the treated animals that died prior to the conclusion of the study. On the basis of observations made, the no observed adverse effect level (NOAEL) for Calcozine YeIlow SPF unblended is considered to be 100 mg/Kg bw/day.
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