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Diss Factsheets
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EC number: 238-122-3 | CAS number: 14246-53-8
- 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:
- 1.57 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- Overall assessment factor (AF):
- 225
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.7 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.222 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- Overall assessment factor (AF):
- 900
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.667 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Workers
No assessment and notably no DNEL is required for the general public because:
- the latter is only exposed via the use of final cosmetic products, excluded from the CSA;1
- assessment of indirect human exposure via the environment is not required, since thesubstance does not require classification as “T/R48”, as a carcinogen or mutagen (of any category), or as toxic to reproduction (category 1 or 2).
No DNEL is required for oral exposure of workers since no significant exposure occurs by this route for trained workers (who do not smoke, eat or drink when manipulating chemicals).
No DNELs are required for acute toxic effects, sensitization and skin irritation because the substance does not possess these properties and long-term DNELs are sufficient to cover systemic effects, as a worst-case. Furthermore most of these DNELs can not be calculated with the available qualitative or single-dose data.
No DNEL for eye irritation can be derived as the corresponding test is qualitative.
No additional assessment factor for route-to-route extrapolation has been used when deriving dermal and inhalation DNELs from data obtained in oral studies. Indeed, the dermal absorption by oral route (solubilised ground substance given by gavage in the study under section 5.6.1.1 of the CSR; expected good oral absorption as discussed under section 5.1of the CSR) is considered to be at least as high as absorption by dermal and respiratory routes (two routes by which absorption is probably not null but of undetermined extent, as discussed under section 5.1of the CSR).
An additional assessment factor of 3 has been used to derive the developmental DNEL because of the limited extent of pup examinations in OECD 422 vs. OECD 414
For the dermal route, oral an assessment factor of 900 is applied and is justified as followed:
No additional assessment factor for route-to-route extrapolation has been used when deriving dermal and inhalation DNELs from data obtained in oral studies. Indeed, the dermal absorption by oral route is considered to be at least as high as absorption by dermal and respiratory routes (2 routes by which absorption is expected to be virtually null). The oral route is therefore an extreme worst-case situation in terms of absorption and the DNELs derived from oral data can be considered as being very conservative.
- interspecies, allometric scaling factor =1
Assessment factors(worker)
- Interspecies = 4*2.5 = 10
- Intraspecies: 5
- Exposure duration sub-acute (28 days to chronic) = 6
- Reliability of the dose-response data = 1 (NOAELs availables, no severe effect)
- Quality of the complete endpoint-specific database = 1 for repeated dose toxicity and fertility; 3 for developmental toxicity
- Overall assessment factors: 300 for repeated dose toxicity and fertility; 900 for developmental toxicity
=>DNEL = 200/900 = 0.222 mg/kg/d
For the inhalation route, an assessment factor of 225 is applied and is justified as followed:
For route-to-route extrapolation, the calculation approach follows the Guidelines predefined (see R:8-2).
-Corresponded volume for relevant duration: Worker: 10 m3 (8hours light work)
=>NOEC (worker, 8 h) = 200 x 1/0.38 x 6.7/10 = 353 mg/m3
Assessment factors(worker)
- Interspecies, remaining differences= 2.5
-Intraspecies = 5
- Exposure duration subacute (28 days) to chronic = 6
- Reliability of the dose-response data = 1 (NOAELs availables, no severe effect)
- Quality of the complete endpoint-specific database = 1 for repeated dose toxicity and fertility; 3 for developmental toxicity
Overall assessment factors: 75 for repeated dose toxicity and fertility; 225 for developmental toxicity
=>DNEL = 353/225 = 1.57 mg/m3
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
General population
No assessment and notably no DNEL is required for the general public, as the latter is only exposed to the substance via the use of final cosmetic products. Assessment of human health effects for such exposure is not required by REACH.
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.