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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 220-150-2 | CAS number: 2643-07-4
- 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
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DMEL (Derived Minimum Effect Level)
- Value:
- 10 µg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- Overall assessment factor (AF):
- 10
Workers - Hazard for the eyes
Additional information - workers
Due to the toxicological profile and the physico-chemical properties of the test substance, only the dermal route is a relevant route of exposure for human workers. Therefore, the dermal DNEL for local effects derived from a skin sensitisation study in mice (LLNA) and the dermal DNEL for systemic effects derived from a 28-day oral repeated dose study in rats are considered sufficient to ensure the safety of human workers.
Acute / short-term exposure - local effects:
An induction-specific DNEL was derived for skin sensitisation based on the EC3 value from a LLNA study (BASF SE, 2010). The sensitisation threshold (EC3 value) was reported to be 0.8% w/w, indicative of a sensitiser of strong potency. According to the Guidance on information requirements and chemical safety assessment, Chapter R.8, the EC3 value (in mg/cm²) can be used as a surrogate for the NOAEL for induction.
Therefore the EC3 (%) was converted to the EC3 (µg/cm²) using the formula
EC3 (%) x 250 (µg/cm²/%) = EC3 (µg/cm²) = 0.8 x 250 = 200 µg/cm².
EC3 data generally correlate well with human skin sensitisation thresholds. However, there are cases where this correlation is poor and the two values may differ by 10-fold or more. Therefore, using the default AF of 10 for interspecies variation, the acute dermal DNEL was calculated to be 20 µg/cm² = 0.020 mg/cm².
Long-term exposure – systemic effects:
Due to the severe toxic effects of the substance (mutagenic in all available in vitro genotoxicity tests, potentially carcinogenic) a DMEL has been derived. Due to the physicochemical properties of the substance the dermal route is the only relevant exposure route for workers.
Due to the existing database for this substance (lack of a carcinogenicity study) the dermal DMEL after long-term exposure was derived based on the NOAEL value in female rats from a subacute (28 days) repeated dose toxicity study by oral application (BASF SE, 2010). In this study,the oral administration ofthe test substanceby gavage over a period of 4 weeks caused incipient signs of general systemic toxicity at dose levels of 10 mg/kg bw/d in female animals (clinicochemical parameters:decreased total protein and calcium levels) and 40 mg/kg bw/d in both genders.Therefore,under the conditions of the present studytheNOAEL was2.5 mg/kg bw/din female and 10 mg/kg bw/d in male Wistar rats.
The NOAEL of 2.5 mg/kg body weight in female animals which was taken as relevant dose descriptor for systemic effects after long-term exposure has been modified in order to get the correct starting point for dermal DNEL derivation:
In the first step, a route-to-route extrapolation within the species rat was performed. The oral rat NOAEL was converted into the dermal rat NOAEL on the assumption that, in general, dermal absorption will not be higher than oral absorption (i.e. factor 1). The resulting corrected starting point for dermal DNEL derivation is equal to 2.5 mg/kg body weight.
The following assessment factors (AF) were applied to the correct starting point:
Interspecies variation:
An allometric scaling factor of 4 for interspecies extrapolation (rat to man) was recognised by default. Since incipient signs of general systemic toxicity at dose levels as low as 10 mg/kg bw/d in female animals (clinicochemical parameters) and 40 mg/kg bw/d in both genders were the relevant adverse clinical finding in this study, and due to the otherwise severe toxicological profile of the substance (toxic if swallowed, harmful in contact with skin, irritating to skin, may cause sensitisation by skin contact, danger of serious damage to health by prolonged exposure if swallowed, mutagenic) an additional assessment factor of 2.5 for remaining differences in interspecies variation was applied.
Intraspecies variation:
The intraspecies variation among human workers was recognised by an assessment factor of 5 by default.
Exposure duration:
An assessment factor of 6 was used for extrapolation of exposure duration from sub-acute (28-day study) to chronic by default.
Dose-response:
An assessment factor of 1 was used by default.
Quality of whole database:
An assessment factor of 1 was used by default.
Accordingly, an overall assessment factor of 300 was calculated based on the recommendations given in the Guidance on information requirements and chemical safety assessment, Chapter R.8 (ECHA, May 2008, Figure R.8-6, p. 38) and based on the above mentioned arguments. Thus, the dermal DMEL for long-term exposure was calculated as follows:
Dermal DMEL long-term exposure – systemic effects = corrected dermal NOAEL / Overall AF = 2.5 mg/kg body weight / 300 = 0.0083 = approx. 0.01 mg/kg body weight.
General Population - Hazard via inhalation route
Systemic effects
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
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Exposure to the general population is not expected, and therefore a DNEL and/or DMEL has not been established.
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.