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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
Endpoint summary
Administrative data
Description of key information
Repeated dose toxicity: oral
The No Observed Adverse Effect Level (NOAEL) for Calcozine YeIlow SPF Unblended is considered to be 100 mg/Kg bw/day.
Repeated dose toxicity: inhalation
According to Annex IX of the REACH regulation, testing by the
inhalation route is appropriate only if exposure of humans via
inhalation is likely. Taking into account the low vapour pressure of the
substance 4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride,
which is reported as 0.00000000015 Pa. Thus, exposure to inhalable dust,
mist and vapour of the chemical
4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride is highly
unlikely. Therefore this study is considered for waiver.
Repeated dse toxicity: dermal
The acute toxicity value for
4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride (as provided
in section 7.2.3) is >2000 mg/kg body weight. Thus, it is expected that
4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride shall not
exhibit 28 day repeated dose toxicity by the dermal route. In addition,
there is no data available that suggests that
4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride shall
exhibit repeated dose toxicity by the dermal route. Hence this end point
was considered for waiver.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- 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
- 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
- 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 - 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
- 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
- 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
- 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
- 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. - 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
- Critical effects observed:
- not specified
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Data is from NTRL report
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity oral:
Data for the target chemical along with its structurally related substance was reviewed to determine the toxic nature of 4,4'-carbonimidoylbis(N,N-diethylaniline) monohydrochloride upon repeated exposure by oral route. The summary is as mentioned below:
In NTRL study reportOTS0539600; B 8723; 1992,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 livf'r 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 nor-mal 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.
Four groups of five male and five female Wistar rats received structurally related substance Acid Red 52 (CAS 3520 -42 -1) daily by gavage at doses of 0, 100, 300 and 1000 mg/kg bw/day for 14 days (cited inTHE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS (SCCNFP) /0803/ 23 April 2004). The test material (purity specified about 80 %, Lot. 18882) was homogenized in bi-distilled water containing 1 % Carboxymethylcellulose sodium salt (CMC). Clinical signs, food consumption and body weights were recorded periodically during pretest, and treatment period. All animals were killed, necropsied and examined post mortem. No death occurred during the 14-day treatment period. In all treated animals, violet faeces were observed until the end of the treatment period. This was considered to be a typical passive effect resulting from oral administration of dyestuff and is not considered to be a sign of toxicity. The absolute and relative kidney weights of males treated with 1000 mg/kg bw/day was lower than those of control animals. This finding was considered to be incidental. No other test substance related changes were observed, hence the No-Observable-Adverse-Effect-Level (NOAEL) of sodium 4-[3,6-bis(diethylamino)-2,7-dimethylxanthenium-9-yl]benzene-1,3-disulfonate (Acid Red 52) is considered to be 1000 mg/kg bw/day when administered by gavage over a period 14 days.
Based on the data summarized, 4,4'-carbonimidoylbis(N,N-diethylaniline) hydrochloride is not likely to be toxic upon repeated exposure by oral route. Thus, the chemical is not classified as a toxicant as per the criteria mentioned in CLP regulation.
Repeated dose toxicity: inhalation
According to Annex IX of the REACH regulation, testing by the
inhalation route is appropriate only if exposure of humans via
inhalation is likely. Taking into account the low vapour pressure of the
substance 4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride,
which is reported as 0.00000000015 Pa. Thus, exposure to inhalable dust,
mist and vapour of the chemical
4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride is highly
unlikely. Therefore this study is considered for waiver.
Repeated dse toxicity: dermal
The acute toxicity value for
4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride (as provided
in section 7.2.3) is >2000 mg/kg body weight. Thus, it is expected that
4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride shall not
exhibit 28 day repeated dose toxicity by the dermal route. In addition,
there is no data available that suggests that
4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride shall
exhibit repeated dose toxicity by the dermal route. Hence this end point
was considered for waiver. )
Justification for classification or non-classification
Based on the data summarized, 4,4'-carbonimidoylbis(N,N-diethylaniline) monohydrochloride is not likely to be toxic upon repeated exposure by oral route. Thus, the chemical is not classified as a toxicant as per the criteria mentioned in CLP regulation.
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.
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