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EC number: 221-220-5 | CAS number: 3033-62-3
- 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
Endpoint summary
Administrative data
Description of key information
Repeated dose toxicity - oral:
A seven day dietary study of low reliability (Klimisch 4) was conducted in rats with doses of 0, 150, 220 and 320 mg/kg bw/day (Carnegie-Mellon, 1975). No significant effects were associated with the 150 mg/kg/day dose, which was considered the NOEL for systemic toxicity.
Repeated dose toxicity - inhalation:
A 90 day whole body vapour inhalation study was conducted in rats similar to OECD guidelines with a reliability score of 2 (BRRC, 1993). Doses were 0, 0.22, 1.25 and 5.8 ppm (1.51, 8.2 and 38 mg/m3). There were signs of ocular and respiratory irritation at all doses. The NOAEC for systemic effects is considered to be 1.25 ppm (8.2 mg/m3). An LOAEC value for local effects of 0.23 ppm (1.51 mg/m3) was determined based on various signs of eye and respiratory tract irritation at all concentrations.
Repeated dose toxicity - dermal:
A 90 day dermal study was conducted in rabbits according to OECD guideline 411 with a reliability score of 2 (BRRC, 1984). The NOAEL for systemic effects was considered to be greater than the highest tested dose of 8.0 mg/kg bw/day. All dose levels tested resulted in varying levels of irritation at the exposure site.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- No studies of sufficient quality or reliability are available for this endpoint.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 8.2 mg/m³
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- A 90 day whole body vapour inhalation study was conducted in rats similar to OECD guidelines with a reliability score of 2. No other reliable repeated dose inhalation studies are available for this substance.
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEC
- 1.51 mg/m³
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- A 90 day whole body vapour inhalation study was conducted in rats similar to OECD guidelines with a reliability score of 2. No other reliable repeated dose inhalation studies are available for this substance.
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 8 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rabbit
- Quality of whole database:
- A 90 day dermal study was conducted in rabbits according to OECD guideline 411 with a reliability score of 2. Due to the test substance being corrosive, local irritation effects prevented appropriately high systemic exposure to occur. For this reason, a NOAEL is not reported here. No other reliable repeated dose dermal studies are available for this substance.
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Study duration:
- subchronic
- Species:
- rabbit
- Quality of whole database:
- A 90 day dermal study was conducted in rabbits according to OECD guideline 411 with a reliability score of 2. Varying levels of skin irritation were seen at all dose levels and thus a NOAEL could not be derived for local effects. No other reliable repeated dose dermal studies are available for this substance.
Additional information
Repeated dose toxicity - oral:
No studies of sufficient quality are available for this endpoint.
A seven day dietary study of low reliability (Klimisch 4) was conducted in rats with doses of 0, 150, 220 and 320 mg/kg bw/day (Carnegie-Mellon, 1975). No significant effects were associated with the 150 mg/kg/day dose, which was considered the NOEL for systemic toxicity. An LOAEL for local effects is established at 220 mg/kg bw/day.
Repeated dose toxicity - inhalation:
A 90 day whole body vapour inhalation study was conducted in rats
similar to OECD guidelines with a reliability score of 2. Doses were 0,
0.23, 1.25 and 5.8 ppm (1.51, 8.2 and 38.0 mg/m3). There were signs of
ocular and respiratory irritation at all doses. Evidence of minor,
non-specific systemic toxicity (weight loss, changes in urinalysis and
increase in relative weight of the testes and adrenals in males) was
only observed at the highest dose of 5.8 ppm (38 mg/m3). No target organ
toxicity was observed at any dose level. The NOAEC for systemic effects
is therefore considered to be 1.25 ppm (8.2 mg/m3). An LOAEC value for
local effects of 0.23 ppm (1.51 mg/m3) was determined on the basis of
various signs of eye and respiratory tract irritation at all
concentrations. A NOAEC could not be determined for irritancy under the
conditions of this study as signs of irritation were observed in male
and female rats even at the lowest concentration.
Two short-term toxicity studies via inhalation of low reliability (K4) were available (BRRC, 1988; BRRC, 1989).
Repeated dose toxicity - dermal:
A 90 day dermal study was conducted in rabbits according to OECD
guideline 411 with a reliability score of 2 (BRRC, 1984). Doses were
2.0, 0.7 and 0.2% corresponding to nominal doses of 8.0, 2.8 and 0.27
mg/kg/ bw/day, 6 hours per day, 5 days per week. The doses were chosen
based on a range-finding study that showed local irritation at the
lowest dose tested (2.5%). There were no effects at any dose on body
weight and food consumption, gross pathology, histopathology or organ
weights. The NOAEL was considered to be greater than the highest tested
dose of 8.0 mg/kg bw/day. All dose levels tested resulted in varying
levels of irritation at the exposure site. A DNEL could not be derived
as, per Chapter R.8 of the ECHA Guidance, a DNEL should preferably cover
both systemic and local effects. DNELs for systemic effects can in
principle be based on all types of studies, unless low dose local
effects prevent appropriately high systemic exposure to occur.
Daily recurrent application of the test substance to intact skin of
rabbits, over a period of 90 days at concentrations of 2.0, 0.7, and
0.2% produced local dermal inflammation (including: erythema, edema,
desquamation, fissuring, and by microscopic examination epidermal
vacuolization and acanthosis were observed) but no signs of toxicity.
A DNEL could not be derived for local effects (irritation/corrosion).
Varying levels of skin irritation were seen at all dose levels and thus
a NOAEL could not be derived for local effects. No statistical analysis
was provided therefore a LOAEL could not be determined. Following the
ECHA Guidance, a qualitative assessment will be performed.
A short-term repeated dose toxicity study via dermal administration of low reliability was available.
Justification for classification or non-classification
Based on the outcomes of the available repeated dose studies, classification for specific target organ toxicity - after repeated exposure is not required according to Regulation (EC) 1272/2008 (CLP).
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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