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EC number: 298-265-2 | CAS number: 93783-70-1
- 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:
- 0.576 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 35 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 43.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEL obtained in a 28 -day study in rats was selected as the most representative starting dose based on: study duration; presence of adverse effects, which were completely reversible during a 2 -week recovery period; type of observations and parameters taken into account to identify effect levels.
In comparison, in studies of toxicity to reproduction to assess teratogenic effects in rats, animals were dosed for a shorter period, i.e. from day 6 to 15 of pregnancy; observations were mainly focused on reproductive parameters and few details on the general toxicity of the substance were reported; in the preliminary assay, a NOAEL of 20 mg/kg (17 mg/kg a.i.) and LOAEL of 80 mg/kg (68 mg/kg a.i.) were identified based on maternal toxicity and a NOAEL of 80 mg/kg (68 mg/kg a.i.) for teratogenicity; in the main assay, lower doses were tested and no adverse effects were recorded (tested doses: 1.5, 5, 15 mg/kg).
Starting from an oral dose of 35 mg/kg (NOAEL) as a.i. corresponding to 40 mg/kg as test material, a corrected value is obtained, based on: 8-h breathing volume of rat (0.38 m3/kg) and 8-h breathing volume of human (6.7 m3/kg in general population and 10 m3/kg in worker); days per week of exposure in experimental animals (7 d/w) and in humans (5 d/w in workers).
No experimental data on absorption via oral and inhalation route was available. Worst case assumption for absorption was: 50 % orally and 100 % by inhalation.
NOAEC = ((35 mg/kg bw/day : 0.38 m3/kg) × (6.7 m3: 10 m3)) × (7 d/w : 5 d/w) × 0.5 = 43.2 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Modified descriptor starting point is a NOAEC.
- AF for differences in duration of exposure:
- 6
- Justification:
- extrapolation from subacute to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- implicitly included in the corrected starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part)
- AF for intraspecies differences:
- 5
- Justification:
- workers
- AF for the quality of the whole database:
- 1
- Justification:
- good quality and reliability
- AF for remaining uncertainties:
- 1
- Justification:
- no significative remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
Absorption by dermal route is expected to be low based on:
- low toxicity by dermal route compared to oral route as suggested by a LD50 > 2000 mg/kg by dermal route and LD50 between 50 and 300 mg/kg by oral route;
- water solubility of 25.22 g/l and logPow of -0.3993, i.e. above 10 g/l and below 0 respectively, thus limiting the penetration into the stratum corneum;
- presence of heterocyclic ammonium ions in the molecule that may bind to skin components.
However, the substance is classified as skin sensitising (cat. 1B of the CLP Regulation EC 1272/2008). Skin sensitisation is a non-threshold endpoint, thus a repeated exposure to test substance may cause hypersensitivity reactions even in case of low absorption potential.
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
In general, the calculation of a DNEL is based on the observed effect level and has to be corrected for the differences between effect assessment data and the real human exposure situation, taking into account variability and uncertainty within and between species. If there is no basis for setting a DNEL or DMEL for a given human health endpoint, i.e. due to the lack of quantitative dose-response information, but there exists toxicity data of a qualitative nature, a qualitative risk assessement is performed. This kind of situation typically occurs with data on irritation/corrosion, sensitisation, acute toxicity, mutagenicity, and carcinogenicity.
INHALATION ROUTE
Systemic effects after long term exposure
The substance is a powder and particles have a mass-median diameter of 35 µm and ca. 97 % of particles is below 100 µm size. The fraction of respirable particles, which may enter the alveolar region and become systemically available upon absorption, is less than 2 %. Despite the low potential for systemic exposure via inhalation, a DNEL is derived.
The starting point to derive a long term DNEL for inhalation route was a NOAEC of 43.2 mg/m3derived from a NOAEL of 35 mg/kg bw/d (highest tested dose in a repeated dose toxicity study in rats by oral route) properly corrected for route-to-route extrapolation, namely accounting for rat breathing volume and human (worker) breathing volume. Worst case for absorption rate was assumed, namely 50 % by oral route and 100 % by inhalation. Assessment factors were used to derive the DNEL:
- remaining interspecies differences 2.5
- intraspecies differences 5, for workers
- differences in duration of exposure 6, because the starting value resulted from a subacute study.
Systemic effects after acute exposure
No acute inhalation toxicity study was available. However, as the inhaled substance may likely enter the gastrointestinal tract via clearance mechanism and the substance is classified for acute oral toxicity (cat. 3 of the CLP Regulation), a systemic acute effect upon inhalation may occur and a medium hazard is expected.
Local effects after acute and long term exposure
The substance is a powder and particles have a mass-median diameter of 35 µm. Based on the particle size distribution, 97 % of particles has a diameter below 100 µm. Mucous lining the respiratory tract may be exposed to the substance and may enter the gastrointestinal tract as a consequence of clearance mechanisms.
As the substance causes eye damage and causes damage to the gastrointestinal tract in studies by oral route, an effect on mucous of respiratory and gastrointestinal tracts upon inhalation may occur and a medium hazard is expected.
DERMAL ROUTE
Molecular structure of the substance, physicochemical properties and findings in studies by dermal route are indicative of a low potential for absorption by dermal route.
Systemic effects after long term and acute exposure
Systemic effects upon dermal exposure were assessed in a skin sensitisation study. The substance resulted as sensitising, with positive responses to challenge in 50 % of tested animals and no threshold for either induction or elicitation, based on available data.
Based on the potency categorisation for guinea pig maximisation test, reported in ECHA guidance R.8, the substance is considered a moderate sensitiser and a medium hazard is expected.
Local effects after long term and acute exposure
No long term studies upon dermal exposure were available. As no local effects were noted in skin irritation studies and in an acute toxicity test by dermal route, the substance resulted as non irritant and no local hazard is expected.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 86.3 µg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 35 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 13 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEL obtained in a 28 -day study in rats was selected as the most representative starting dose based on: study duration; presence of adverse effects, which were completely reversible during a 2 -week recovery period; type of observations and parameters taken into account to identify effect levels.
In comparison, in studies on toxicity to reproduction to assess teratogenic effects in rats, animals were dosed for a shorter period, i.e. from day 6 to 15 of pregnancy; observations were mainly focused on reproductive parameters and few details on the general toxicity of the substance were reported; in the preliminary assay, a NOAEL of 20 mg/kg (17 mg/kg a.i.) and LOAEL of 80 mg/kg (68 mg/kg a.i.) were identified based on maternal toxicity and a NOAEL of 80 mg/kg (68 mg/kg a.i.) for teratogenicity; in the main assay, lower doses were tested and no adverse effects were recorded (tested doses: 1.5, 5, 15 mg/kg).
Starting from an oral dose of 35 mg/kg (NOAEL) as a.i. corresponding to 40 mg/kg as test material, a corrected value is obtained, based on 24-h breathing volume of rat (1.15 m3/kg). Exposure conditions of experimental animals and humans (general population) are the same, i.e. 7 days per week.
No data on absorption via oral and inhalation route was available. Worst case assumption for absorption was: 50 % orally and 100 % by inhalation.
NOAEC = ((35 mg/kg bw/day : 1.35 m3/kg) × 0.5 = 13 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Modified descriptor starting point is a NOAEC.
- AF for differences in duration of exposure:
- 6
- Justification:
- extrapolation from subacute to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- implicitly included in the corrected starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part)
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- good quality and reliability
- AF for remaining uncertainties:
- 1
- Justification:
- no significative remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 58.3 µg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 35 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 35 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No extrapolation.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL clearly identified
- AF for differences in duration of exposure:
- 6
- Justification:
- extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default value
- AF for other interspecies differences:
- 2.5
- Justification:
- toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part).
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- good quality and reliability
- AF for remaining uncertainties:
- 1
- Justification:
- no significative remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
In general, the calculation of a DNEL is based on the observed effect level and has to be corrected for the differences between effect assessment data and the real human exposure situation, taking into account variability and uncertainty within and between species. If there is no basis for setting a DNEL or DMEL for a given human health endpoint, i.e. due to the lack of quantitative dose-response information, but there exists toxicity data of a qualitative nature, a qualitative risk assessement is performed. This kind of situation typically occurs with data on irritation/corrosion, sensitisation, acute toxicity, mutagenicity, and carcinogenicity.
INHALATION ROUTE
Systemic effects after long term exposure
The substance is a powder and particles have a mass-median diameter of 35 µm and ca. 97 % of particles is below 100 µm size. The fraction of respirable particles, which may enter the alveolar region and become systemically available upon absorption, is less than 2 %. Despite the low potential for systemic exposure via inhalation, a DNEL is derived.
The starting point to derive a long term DNEL for inhalation route was a NOAEC of 13 mg/m3derived from a NOAEL of 35 mg/kg bw/d (highest tested dose in a repeated dose toxicity study in rats by oral route) properly corrected for route-to-route extrapolation, namely accounting for rat breathing volume and human (worker) breathing volume. Worst case for absorption rate was assumed, namely 50 % by oral route and 100 % by inhalation. Assessment factors were used to derive the DNEL:
- remaining interspecies differences 2.5
- intraspecies differences 10, for general population
- differences in duration of exposure 6, because the starting value resulted from a subacute study.
Systemic effects after acute exposure
No acute inhalation toxicity study was available. However, as the inhaled substance may likely enter the gastrointestinal tract via clearance mechanism and the substance is classified for acute oral toxicity (cat. 3 of the CLP Regulation), a systemic acute effect upon inhalation may occur and a medium hazard is expected.
Local effects after acute and long term exposure
The substance is a powder and particles have a mass-median diameter of 35 µm. Based on the particle size distribution, 97 % of particles has a diameter below 100 µm. Mucous lining the respiratory tract may be exposed to the substance and may enter the gastrointestinal tract as a consequence of clearance mechanisms.
As the substance causes eye damage and causes damage to the gastrointestinal tract in studies by oral route, an effect on mucous of respiratory and gastrointestinal tracts upon inhalation may occur and a medium hazard is expected.
DERMAL ROUTE
Molecular structure of the substance, physicochemical properties and findings in studies by dermal route are indicative of a low potential for absorption by dermal route.
Systemic effects after long term and acute exposure
Systemic effects upon dermal exposure were assessed in a skin sensitisation study. The substance resulted as sensitising, with positive responses to challenge in 50 % of tested animals and no threshold for either induction or elicitation, based on available data.
Based on the potency categorisation for guinea pig maximisation test, reported in ECHA guidance R.8, the substance is considered a moderate sensitiser and a medium hazard is expected.
Local effects after long term and acute exposure
No long term studies upon dermal exposure were available. As no local effects were noted in skin irritation studies and in an acute toxicity test by dermal route, the substance resulted as non irritant and no local hazard is expected.
ORAL ROUTE
Systemic effects after long term exposure
The starting point to derive a DNEL for oral long-term exposure was a NOAEL of 35 mg/kg bw/d obtained from a repeated dose toxicity study. This was the highest tested dose, at which systemic effects were found to be completely reversible at the end of the recovery period. Assessment factors were used to derive DNEL:
- differences in duration of exposure 6, because the starting value resulted from a subacute study
- interspecies differences 4, from rat to human
- remaining differences 2.5
- intraspecies differences 10, for general population.
Systemic effects after acute exposure
The substance is classified for acute toxicity in cat. 3 of the CLP Regulation (EC 1272/2008), thus it is considered as moderately toxic and a medium hazard is expected.
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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