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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
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EC number: 947-350-9 | CAS number: -
- 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:
- 0.544 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 225
- Dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 1 960 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No long-term exposure data is available for the inhalation route, therefore, the NOAEL/LOAEL resulted from an animal study after an oral administration of the substance for at least 28 days to rats, is used. Route-to-route extrapolation is therefore needed from the oral to the inhalation route. The most sensitive value was found in the Reproductive/Developmental Screening Test combined with Repeated Dose Toxicity test. The lowest dose administered to treatment animals was 100 mg/kg bw/day, which was subsequently associated with developmental toxicity of offspring. Therefore, the LOAEL value is considered 100 mg/kg bw/day and the NOAEL value is less than 100 mg/kg bw/day, therefore, it is implied that the NOAEL value cannot be extrapolated from this study.
As the LOAEL value was particular to rats, it is necessary to divide the LOAEL value by a factor of 4 to consider inter-species differences; the standard body weight considered for workers is 70 kg, therefore, the LOAEL is multiplied by a factor of 70 kg. A worker is considered to be exposed to 10 m3 for 8 hours per day for 5 days out of 7, therefore, the LOAEL value is multiplied by 10 m3 and a factor of 1.4 to account for weekends. Finally, absorption of a substance by the inhalation route is considered to be 100 % once it reaches the alveolar level, whereas absorption via the oral route is considered generically to be 50 %, therefore, the LOAEL value is multiplied by 0.5 to account for absorption differences.
Based on these considerations, the following formula is applied:
LOAEChuman, inhalation = LOAELrat, oral ÷ 4 × 70 kg ÷ 10 m3 × 1.4 × 0.5 = 122.5 mg/m3
Subsequent assessment factors (AF) are then applied as detailed below. The overall assessment factor was found to be 225.
- AF for dose response relationship:
- 3
- Justification:
- AF for dose response relationship is considered 3 as the source study does not specify a NOAEL and the LOAEL is extrapolated from the lowest dose tested
- AF for differences in duration of exposure:
- 6
- Justification:
- AF for differences in duration of exposure is considered 6 as the source study is a sub-acute toxicity study (51-day reproductive/developmental screening combined with repeated dose toxicity; OECD 422)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Interspecies differences are already considered in the original formula (above), whereby the LOAEL was multiplied by a factor of 4 to allow for differences between rats and humans
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences)
- AF for intraspecies differences:
- 5
- Justification:
- AF for intraspecies differences is considered 5 to allow for potential differences in the population of workers
- AF for the quality of the whole database:
- 1
- Justification:
- Good standard of quality of database
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.556 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 900
- Dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 1 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No long-term exposure data is available for the dermal route, therefore, the NOAEL/LOAEL value used resulted from an animal study whereby the substance was administered orally for at least 28 days to rats. Route-to-route extrapolation is therefore needed from the oral to the dermal route.The most sensitive value was found in the Reproductive/Developmental Screening Test combined with Repeated Dose Toxicity test.
The lowest dose administered to treatment animals was 100 mg/kg bw/day, which was subsequently associated with developmental toxicity of offspring. Therefore, the LOAEL value is considered 100 mg/kg bw/day and the NOAEL value is less than 100 mg/kg bw/day, therefore, it is implied that the NOAEL value cannot be extrapolated from this study.
A worker is considered to be exposed to a substance for 5 days out of 7, therefore, the LOAEL value is multiplied by a factor of 1.4. Although the mean molecular weight of the main structures of the substance are slightly lower than the minimum cut-off value for low skin absorption, polyborate species complexed with N-methyldiethanolamine may be in fact much larger than the 500 g/mol cut-off; therefore, the skin absorption value allocated is 10 % as the octanol-water partition coefficient value satisfies the requirements for 10 % dermal absorption (below -1 or above 4) and the known dermal absorption values of the two main structures of the substance are 0.5 % and 17 to 21 %.
Based on these considerations, the following formula is applied:
LOAEChuman, dermal = LOAELrat, oral × 1.4 / 10 % = 1400 mg/kg
Subsequent assessment factors (AF) are then applied as detailed below. The overall assessment factor was found to be 900.
- AF for dose response relationship:
- 3
- Justification:
- AF for dose response relationship is considered 3 as the source study does not specify a NOAEL and the LOAEL is extrapolated from the lowest dose tested
- AF for differences in duration of exposure:
- 6
- Justification:
- AF for differences in duration of exposure is considered 6 as the source study is a sub-acute toxicity study (51-day reproductive/developmental screening combined with repeated dose toxicity; OECD 422)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An AF value of 4 is provided for interspecies differences between the rat and human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences)
- AF for intraspecies differences:
- 5
- Justification:
- AF for intraspecies differences is considered 5 to allow for potential differences in the population of workers
- AF for the quality of the whole database:
- 1
- Justification:
- Good standard of quality of database
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.083 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 450
- Dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 37.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No long-term exposure data is available for the inhalation route, therefore, the NOAEL/LOAEL resulted from an animal study after an oral administration of the substance for at least 28 days to rats, is used. Route-to-route extrapolation is therefore needed from the oral to the inhalation route. The most sensitive value was found in the Reproductive/Developmental Screening Test combined with Repeated Dose Toxicity test. The lowest dose administered to treatment animals was 100 mg/kg bw/day, which was subsequently associated with developmental toxicity of offspring. Therefore, the LOAEL value is considered 100 mg/kg bw/day and the NOAEL value is less than 100 mg/kg bw/day, therefore, it is implied that the NOAEL value cannot be extrapolated from this study.
As the LOAEL value was particular to rats, it is necessary to divide the LOAEL value by a factor of 4 to consider inter-species differences; the standard body weight considered for the general population is 60 kg, therefore, the LOAEL is multiplied by a factor of 60 kg. The general population is considered to be exposed to 20 m3 for 24 hours per day, 7 days out of 7, therefore, the LOAEL value is multiplied by 20 m3. Finally, absorption of a substance by the inhalation route is considered to be 100 % once it reaches the alveolar level, whereas absorption via the oral route is considered generically to be 50 %, therefore, the LOAEL value is multiplied by 0.5 to account for absorption differences.
Based on these considerations, the following formula is applied:
LOAEChuman, inhalation = LOAELrat, oral ÷ 4 × 60 kg ÷ 20 m3 × 0.5 = 37.5 mg/m3
Subsequent assessment factors (AF) are then applied as detailed below. The overall assessment factor was found to be 450.
- AF for dose response relationship:
- 3
- Justification:
- AF for dose response relationship is considered 3 as the source study does not specify a NOAEL and the LOAEL is extrapolated from the lowest dose tested
- AF for differences in duration of exposure:
- 6
- Justification:
- AF for differences in duration of exposure is considered 6 as the source study is a sub-acute toxicity study (51-day reproductive/developmental screening combined with repeated dose toxicity; OECD 422)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Interspecies differences are already considered in the original formula (above), whereby the LOAEL was multiplied by a factor of 4 to allow for differences between rats and humans
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences)
- AF for intraspecies differences:
- 10
- Justification:
- AF for intraspecies differences is considered 10 to allow for potential differences in the general population such as age, health, race
- AF for the quality of the whole database:
- 1
- Justification:
- Good/standard quality data base
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.555 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1 800
- Dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No long-term exposure data is available for the dermal route, therefore, the NOAEL/LOAEL value used resulted from an animal study whereby the substance was administered orally for at least 28 days to rats. Route-to-route extrapolation is therefore needed from the oral to the dermal route. The most sensitive value was found in the Reproductive/Developmental Screening Test combined with Repeated Dose Toxicity test.
The lowest dose administered to treatment animals was 100 mg/kg bw/day, which was subsequently associated with developmental toxicity of offspring. Therefore, the LOAEL value is considered 100 mg/kg bw/day and the NOAEL value is less than 100 mg/kg bw/day, therefore, it is implied that the NOAEL value cannot be extrapolated from this study.
The general population is considered to be exposed to a substance 7 days a week (100 %). Although the mean molecular weight of the main structures of the substance are slightly lower than the minimum cut-off value for low skin absorption, polyborate species complexed with N-methyldiethanolamine may be in fact much larger than the 500 g/mol cut-off; therefore, the skin absorption value allocated is 10 % as the octanol-water partition coefficient value satisfies the requirements for 10 % dermal absorption (below -1 or above 4) and the known dermal absorption values of the two main structures of the substance are 0.5 % and 17 to 21 %.
Based on these considerations, the following formula is applied:
LOAEChuman, dermal= LOAELrat, oral / 10 % = 1000 mg/kg
Subsequent assessment factors (AF) are then applied as detailed below. The overall assessment factor was found to be 1800.
- AF for dose response relationship:
- 3
- Justification:
- AF for dose response relationship is considered 3 as the source study does not specify a NOAEL and the LOAEL is extrapolated from the lowest dose tested
- AF for differences in duration of exposure:
- 6
- Justification:
- AF for differences in duration of exposure is considered 6 as the source study is a sub-acute toxicity study (51-day reproductive/developmental screening combined with repeated dose toxicity; OECD 422)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An AF value of 4 is provided for interspecies differences between the rat and human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences)
- AF for intraspecies differences:
- 10
- Justification:
- AF for intraspecies differences is considered 10 to allow for potential differences in the general population
- AF for the quality of the whole database:
- 1
- Justification:
- Good/standard quality of database
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Oral
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No study for the acute dermal toxicity is available for the substance. The substance is classified in Category 1 for skin sensitisation potential without further subclassification based on the skin sensitising potential observed in two out of three in vitro experimental studies and using a Weight of Evidence approach.
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.056 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1 800
- Dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL/LOAEL value used resulted from an animal study whereby the substance was administered orally for at least 28 days to rats. The most sensitive value was found in the Reproductive/Developmental Screening Test combined with Repeated Dose Toxicity test. The lowest dose administered to treatment animals was 100 mg/kg bw/day, which was subsequently associated with developmental toxicity of offspring. Therefore, the LOAEL value is considered 100 mg/kg bw/day and the NOAEL value is less than 100 mg/kg bw/day, therefore, it is implied that the NOAEL value cannot be extrapolated from this study.
Subsequent assessment factors (AF) are then applied as detailed below. The overall assessment factor was found to be 1800.
- AF for dose response relationship:
- 3
- Justification:
- AF for dose response relationship is considered 3 as the source study does not specify a NOAEL and the LOAEL is extrapolated from the lowest dose tested
- AF for differences in duration of exposure:
- 6
- Justification:
- AF for differences in duration of exposure is considered 6 as the source study is a sub-acute toxicity study (51-day reproductive/developmental screening combined with repeated dose toxicity; OECD 422)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An AF value of 4 is provided for interspecies differences between the rat and human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences)
- AF for intraspecies differences:
- 10
- Justification:
- AF for intraspecies differences is considered 10 to allow for potential differences in the general population
- AF for the quality of the whole database:
- 1
- Justification:
- Good/standard quality database
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
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.