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Diss Factsheets
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EC number: 247-665-5 | CAS number: 26401-86-5
- 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:
- 1.06 mg/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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 26.44 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEChuman= NOAELrat× (1/0.38 m3/kg bw) × (6.7m3/10m3) × (100%/100%) = 15 mg/kg bw/day × 1/0.38 × 6.7/10 × 100/100
- AF for dose response relationship:
- 1
- Justification:
- A NOAEL was defined
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scalling is required for inhalation
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point
- AF for intraspecies differences:
- 5
- Justification:
- Default for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Data from target substance supplemented by isomeric read across substance
- AF for remaining uncertainties:
- 2.5
- Justification:
- default- remaining differences
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 750 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 µg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 375 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NOAELhuman= NOAELrat× (oral absorption/dermal absorption) = 15 mg/kg bw/day × (100%/0.004%)
- AF for dose response relationship:
- 1
- Justification:
- A NOAEL was defined
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default – rat to human
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of the starting point
- AF for intraspecies differences:
- 5
- Justification:
- Default for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Data from target substance supplemented by isomeric read across substance
- AF for remaining uncertainties:
- 2.5
- Justification:
- default- remaining differences
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
Additional information - workers
Repeat-dose studies with MOTI (Target substance) and MOTE (Source substance) are available; a Weight of Evidence has been used to take into account all available pieces of information.
In an oral repeat-dose 90-day study in rats with MOTI (Til et al., 1974) the NOAEL was 300 ppm (15 mg/kg bw/day) based on increased relative kidney weight at the 1000 ppm level (but no indication of kidney damage was revealed by function tests or by any of the urine constituents examined). Slightly increased granularity of the cytoplasm of the epithelial cells of the proximal tubules was noted in the kidney of 1000 ppm males at microscopic examination. This endpoint was used as the starting point for long-term systemic DNELs derivation and is considered protective enough for workers.
In an oral 28-day rat study, slightly decreased growth rate and food intake and increased relative weights of the liver and kidneys was noted in 1500 ppm males dietary level during four weeks was accompanied by very slight changes only (Til et al 1973). Increased relative kidney weights accompanied by histological changes at the higher dose levels were noted in another 90-day rat study, for which the LOAEL was set at 300 ppm, based on increased kidney weight (less than 10%), which was not accompanied by any microscopic change (Til et al 1973). The additional 90-day rat study (Drake 1974) gave a lowest NOAEL value at 20 ppm, based on slightly increased absolute and relative adrenal weights in male rats of the 100- and 500-ppm groups. However, because of major deviations this study is considered not reliable (reliability score 4) and therefore was not taken into consideration for selecting an appropriate starting point. In a 90-day dog study, MOTI administration caused slight anaemia at the top-dose of 1000 ppm; the derived NOAEL was 300 ppm (Til et al., 1973). In addition to these repeated dose studies, a 2-generation rat study is also available, where a single dose of MOTI, 300 ppm, was included (a mixture of MOTI and DOTI, 16.9% and 78.8%, respectively, was tested at three dose level in this same study). In this study the NOAEL for DOTI was again 300 ppm because no effects on fertility and development of offspring was noted. Studies using MOTE as the test substance include two 14-day range-finder studies, and a 90-day rat study in which the NOAEL was determined to be the highest tested dose level of 1250 ppm (82 and 91 mg/kg bw/day for males and females, respectively).
MOTI is not an eye or skin irritant and is neither a skin sensitiser.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
No DNELs have been derived for general population as exposure does not occur during the lifecycle of the substance.
The substance is not used by consumers or professionals and only has manufacture, formulation and industrial uses.
The substance is used in the industrial processing of polymers, where it is added as a stabilizer and also as a catalyst/process regulator in the production of polyurethanes or silicones. During the processing of the polymer the substance will be completely used up and as a reactive catalyst the substance is destroyed in the production of polyurethanes or silicones. As such the substance does not exist in the products, therefore in-direct exposure of the general population via releases from the end products are not possible. Indirect exposure of the general population via releases to the environment is also not considered to occur, as the substance is only used in industrial settings where there will be effective waste management processes to prevent release.
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.