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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
Carcinogenicity
Administrative data
Description of key information
Non carcinogenic NOAEL was considered to be 100 mg/kg bw when Albino male and female rats were treated with 4,4'-carbonimidoylbis(N,N-diethylaniline) hydrochloride orally in feed for 20-21 months.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from study report
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 451 (Carcinogenicity Studies)
- Principles of method if other than guideline:
- Carcinogenicity Study of Calcozine Yellow SFW Unblended In Albino Rats
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Calcozine Yellow SFW Unblended (4,4'-carbonimidoylbis(N,N-diethylaniline) hydrochloride)
- Molecular formula (if other than submission substance): C21-H29-N3.Cl-H
- Molecular weight (if other than submission substance): 359.942 g/mole
- Substance type: Organic
- Physical state: No data available
- Purity: No data available
- Impurities (identity and concentrations): No data available - Species:
- rat
- Strain:
- not specified
- Remarks:
- Albino
- Details on species / strain selection:
- No data available
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Remarks:
- Feed
- Remarks on MMAD:
- No data available
- Details on exposure:
- Calcozine Yellow SFW Unblended feed to albino rats at a dIetary level of 0.1%
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 20-21 months
- Frequency of treatment:
- Daily
- Post exposure period:
- No data available
- Remarks:
- 0 and 100.0 mg/kg bw/day
- No. of animals per sex per dose:
- No data available
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- Auramine is used as positive control.
- Observations and examinations performed and frequency:
- Survival and body weight were observed.
- Sacrifice and pathology:
- Gross pathology and histopathology were examined.
- Other examinations:
- No data available
- Statistics:
- No data available
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, non-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:
- not specified
- 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, treatment-related
- Other effects:
- not specified
- Details on results:
- Mortality: No effect on survival of treated rats was observed as compared to control.
Body weight and weight gain: A less marked reduction in body weight gain was observed as compared to positive control.
Gross Pathology: 25 % (7/28) Nodules were observed on the livers of treated male and female rats as compared to 59% (20/34) positive control and No unusual growth was observed in the control rat livers.
Histopathology: non-neoplastic: Primary lesion of focal to diffuse hyplerplastia of the liver cells were observed in treated rats as compared to control but not significant as compared to positive control.
Minor focal lesions of degeneration, necrosis, fatty metamorphosis, inflammation, bile duct proliferation and cholangiofibrosis were observed in the liver of control, positive control and treated animals. However, the severity of these lesions was generally grater in the livers of the positive control animals than in the Iivers of control or treated animals.
Histopathology: 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/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect on survival, body weight, gross pathology and histopathology
- Critical effects observed:
- not specified
- Conclusions:
- Non carcinogenic NOAEL was considered to be 100 mg/kg bw when Albino male and female rats were treated with 4,4'-carbonimidoylbis(N,N-diethylaniline) hydrochloride orally in feed for 20-21 months.
- Executive summary:
In a Carcinogenicity study, Albino male and female rats were treated with 4,4'-carbonimidoylbis(N,N-diethylaniline) hydrochloride in the concentration of 100 mg/kg bw orally in feed. No effect on survival of treated rats was observed as compared to control. A less marked reduction in body weight gain was observed in treated male and female rats as compared to positive control. Similarly, 25 % (7/28) Nodules were observed on the livers of treated male and female rats as compared to 59% (20/34) positive control and No unusual growth was observed in the control rat livers. Primary lesions of focal to diffuse hyplerplastia of the liver cells were observed in treated rats as compared to control but not significant as compared to positive control. Minor focal lesions of degeneration, necrosis, fatty metamorphosis, inflammation, bile duct proliferation and cholangiofibrosis were observed in the liver of control, positive control and treated animals. However, the severity of these lesions was generally grater in the livers of the positive control animals than in the Livers of control or treated animals. In addition, 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 study. But, as compared to positive control (17/23 male and 9/11 female), the number of Hepatomas are less. Therefore, non carcinogenic NOAEL was considered to be 100 mg/kg bw when Albino male and female rats were treated with 4,4'-carbonimidoylbis(N,N-diethylaniline) hydrochloride orally in feed for 20-21 months.
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 Klimisch 4 and from study report
- System:
- other: Not spcified
- Organ:
- not specified
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the above study on 4,4'-carbonimidoylbis(N,N-diethylaniline) hydrochloride, it can be concluded that NOAEL value is 100 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 4-methylphenyl acetate can be “Not classified” for Carcinogenic toxicity.
Additional information
Carcinogenicity- Oral:
In a study,4,4'-carbonimidoylbis(N,N-diethylaniline) hydrochloride(CAS no 6358-36-7) has been investigated for Carcinogenic toxicity to a greater or lesser extent. Study based on in vivo experiment data in rodents, i.e. most commonly in rat for 4,4'-carbonimidoylbis(N,N-diethylaniline) hydrochloride.
In NTRL study report OTS0539600; B 8723; 1992, Carcinogenicity was evaluated in Albino male and female rats by using 4,4'-carbonimidoylbis(N,N-diethylaniline) hydrochloride in the concentration of 100 mg/kg bw orally in feed. No effect on survival of treated rats was observed as compared to control. A less marked reduction in body weight gain was observed in treated male and female rats as compared to positive control. Similarly, 25 % (7/28) Nodules were observed on the livers of treated male and female rats as compared to positive control 59% (20/34) and No unusual growth was observed in the control rat livers. Primary lesions of focal to diffuse hyplerplastia of the liver cells were observed in treated rats as compared to control but not significant as compared to positive control. Minor focal lesions of degeneration, necrosis, fatty metamorphosis, inflammation, bile duct proliferation and cholangiofibrosis were observed in the liver of control, positive control and treated animals. However, the severity of these lesions was generally grater in the livers of the positive control animals than in the Livers of control or treated animals. In addition, 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 study. But, as compared to positive control (17/23 male and 9/11 female), the number of Hepatomas are less. Therefore, non carcinogenic NOAEL was considered to be 100 mg/kg bw when Albino male and female rats were treated with 4,4'-carbonimidoylbis(N,N-diethylaniline) hydrochloride orally in feed for 20-21 months.
Thus, based on the above study on 4,4'-carbonimidoylbis(N,N-diethylaniline) hydrochloride, it can be concluded that NOAEL value is 100 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 4-methylphenyl acetate can be “Not classified” for Carcinogenic toxicity.
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