Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 482-120-7 | CAS number: -
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 428 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.08 mg/cm²
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- Dose descriptor starting point:
- other: LOAEL
Workers - Hazard for the eyes
Additional information - workers
The following DN(M)EL were not derived:
- Dermal for acute / short-term exposure- systemic effects
- Inhalation for acute / short-term exposure- systemic effects
- Inhalation for acute / short-term exposure- local effects
- Dermal for long-term exposure- systemic effects
- Dermal for long-term exposure- local effects
- Inhalation for long-term exposure- local effects
The available data are sufficient to conclude that C-4000 does not pose an acute toxicity hazard via any anticipated route of exposure. It is not corrosive to eyes or skin and produced only slight irritation in rabbits in both organs that was below the minimum to be classified in the GHS. The dermal dose in the appropriate unit is provided as a LOEL for the short-duration erythema and edema noted in the primary dermal irritation study.
C-4000 is a water-insoluble [137 μg/L] liquid of low volatility [VP@100°C = 1.359E-05 hPa)]. This liquid is formulated into pellets 2-5 mm in size to produce the commercial product, ADVAPAK Neo. The ADVAPAK Neo pellets are shipped and are subsequently compounded directly with PVC plastic at the site producing the plastic article, typically PVC pipe. The product formulation and pipe production processes use no water; the cleaning operations use only rinse water that typically goes to a sewage treatment.
The results reported in the toxicology dataset for C-4000 indicate that all treatment-related responses in test animals are threshold effects. None of the toxicological mechanisms involved in elucidating these are based on an assumption of a non-threshold response. This further supports the decision that a correction of dose descriptors for route-to-route extrapolation or the derivation of a DNEL are not necessary for C-4000 for acute effects.The repeated dose results for C-4000 indicate that the NOAEL, 810 mg/kg bw/day basis in rats, is sufficient to prevent a toxic response in any target organ, noting that hypertrophy, an adaptive non-toxic response of the liver and the follicular thyroid, was observed. The NOEL in the prenatal developmental toxicity study was 1000 mg/kg bw/day. Thus, the overall NOAEL is 810 mg/kg bw/day which precludes developmental toxicity and any adverse morphological or functional response in the reproductive organs. Therefore, the NOAEL from the 28-day study for is sufficient to prevent all treatment-related adverse responses in test animals. It follows that the DNEL’s derived from the 28-day study for oral and inhalation exposure are sufficient to prevent adverse health effects in humans.
The treatment-related responses in test animals are all threshold effects. This supports the decision to use only a correction of dose descriptors for route-to-route extrapolation in the derivation of a repeated-dose DNEL for C-4000. No assumption of a non-threshold response is needed in extrapolating the NOAEL dose to possible toxicological responses in humans.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 704 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.08 mg/cm²
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- Dose descriptor starting point:
- other: LOAEL
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 203 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
The following DN(M)EL were not derived:
- Dermal for acute / short-term exposure- systemic effects
- Inahaltion for acute / short-term exposure- systemic effects
- Oral for acute / short-term exposure- systemic effects
- Inhalation for acute / short-term exposure- local effects
- Dermal for long-term exposure- systemic effects
- Dermal for long-term exposure- local effects
- Inahalation for long-term exposure- local effects
Consumers will not be exposed to C-4000 as a pure substance. The use of C-4000 as a component of heat stabilizers for PVC pipe creates the possibility of some consumer exposure via leaching into potable water. Estimates for this have been calculated and found to be quite low. The approval by the Netherlands KIWA / RIVM of C-4000 for use in water pipe supports the industry position that consumer risks via this potential route of exposure are acceptable.
Other potential consumer risks have the same toxicological endpoints of concern as apply to potential risks for workers. The available data are sufficient to conclude that C-4000 will not pose an acute toxicity hazard via any anticipated route of exposure. In addition, C-4000 is not toxic after repeated doses, it does not produce any developmental toxicity, and is not likely to produce any reproductive toxicity. Therefore, the DNEL’s derived from the 28-day study for oral and inhalation exposure are sufficient to prevent adverse health effects in consumers.
The substance, C-4000, does not require special hazard considerations for the general population or special sub-populations, e.g. breast-fed babies, and should carry no classification in the GHS System.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.