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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 946-324-4 | 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:
- 2.13 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 181 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 159.57 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Regarding absorption, in the absence of reliable data for both the starting route (oral) and the end route (inhalation), worst case assumptions were made. It was assumed that a limited absorption occurs by the oral route, leading to a low (conservative) internal NOAEL. To secure a conservative external NOAEL, a maximum absorption should be assumed for the inhalation route (i.e.; 100%) leading to a low external NOAEL. Thus, in the case of oral-to- inhalation extrapolation, it is proposed to include a default factor of 2, i.e. the absorption percentage by oral route is half that of the inhalation absorption as suggested in ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8 (2012).
To convert the oral NOAEL into inhalatory NOAEC, a rat default respiratory volume was used corresponding to the daily duration of human exposure (sRVrat: 0.38 m3/kg bw/8 h). For workers a correction was added for the difference between respiratory rates under standard conditions (sRVhuman: 6.7 m3 for an 8-h exposure period) and under conditions of light activity (wRV: 10 m3 for an 8-h exposure period). Thus, the corrected dose descriptor for inhalation is [181 mg/kg bw/day] X [1/0.38 m3/kg bw/day] X [2/1] X [6.7 m3/10m3]. Thus, the corrected dose descriptor for inhalation is 165.74 mg/m3 for workers.
- AF for dose response relationship:
- 1
- Justification:
- The dose-descriptor is a NOAEL. Table R.8-6 ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for a sub-acute study. Table R.8-5 ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Table R.8-4 ECHA REACH Guidance. Assessment factor not to be used for inhalation route since the differences in the metabolic rate/bw has already been taken into account in the corrected dose descriptor.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for other interspecies differences. Table R.8-6 ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for worker. Table R.8-6 ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor for good/standard quality of the database taken into account completeness of the standard information requirements for the tonnage band
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- 0.603 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 181 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 181 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
For potential dermal exposure, route-to-route extrapolation from the oral NOAEL value was considered appropriate. Since a maximal absorption already occurred by oral route, no additional factor was introduced.
- AF for dose response relationship:
- 1
- Justification:
- The dose-descriptor is a NOAEL. Table R.8-6 ECHA REACH Guidance.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for a sub-acute study. Table R.8-5 ECHA REACH Guidance.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric scaling factor for rats. Table R.8-4 ECHA REACH Guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for other interspecies differences. Table R.8-6 ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for worker. Table R.8-6 ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor for good/standard quality of the database taken into account completeness of the standard information requirements for the tonnage band
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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
NOAEL (systemic toxicity) = 3,000 ppm diet (181 mg/kg bw/d); OECD 422; Anon. (2017)
Long-term systemic hazard assessment for this substance to workers is based on a sub-acute repeated dose toxicity study, combined with reproduction and developmental screening (OECD 422, Anon., 2017). During the treatment period, a dose-dependent decrease in overall mean body weight gain was apparent in all groups, with a greater extent seen in groups treated at 7500 ppm, of toxicity and recovery phase males and females exposed to the test item when compared to controls; this decrease in overall weight gain was largely attributable to lower body weight gain and body weight losses during Week 1. This coincides with the reduced food intake seen in the first few days of treatment. A similar trend in body weight performance was evident among the reproductive phase females in the gestation and lactation period and was considered to be an adverse effect. Within the scope of this study it was not possible to establish with certainly the aetiology of the potentially adverse reduction in birth weight and subsequent body weight gain of the male offspring in the 3000 and 7500 ppm group and female offspring in the 7500 ppm group. This may have been as a result of the parent females being smaller and consuming less food (thus there being reduced levels of nutrients available to pass to the fetus in utero and reduced quality milk in lactation), or a direct effect ofthe test item by cross‑placental in utero exposure. The reduction in body weight gain of the offspring derived from parent animals given 7500 ppm was considered adverse.
The lowest NOAEL (3,000 ppm diet, equivalent to 181 mg/kg bw/d) was therefore used to derive the worker DNELs in accordance with ECHA Guidance.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.525 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 181 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 78.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Regarding absorption, in the absence of reliable data for both the starting route (oral) and the end route (inhalation), worst case assumptions were made. It was assumed that a limited absorption occurs by the oral route, leading to a low (conservative) internal NOAEL. To secure a conservative external NOAEL, a maximum absorption should be assumed for the inhalation route (i.e.; 100%) leading to a low external NOAEL. Thus, in the case of oral-to- inhalation extrapolation, it is proposed to include a default factor of 2, i.e. the absorption percentage by oral route is half that of the inhalation absorption as suggested in ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8 (2012). To convert the oral NOAEL into inhalatory NOAEC, a rat default respiratory volume was used corresponding to the daily duration of human exposure (sRVrat: 1.15 m3/kg bw/24 h). Thus, the corrected dose descriptor for inhalation is [181 mg/kg bw/day] x [1/1.15 m3/kg bw/ day] x [2/1]. Thus, the corrected dose descriptor for inhalation is 78.70 mg/m3 for the general population.
- AF for dose response relationship:
- 1
- Justification:
- The dose-descriptor is a NOAEL. Table R.8-6 ECHA REACH Guidance.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for a sub-acute. Table R.8-5 ECHA REACH Guidance.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Table R.8-4 ECHA REACH Guidance. Assessment factor not to be used for inhalation route since the differences in metabolic rate/bw has already been taken into account for the corrected dose descriptor.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for other interspecies differences. Table R.8-6 ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population. Table R.8-6 ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor for good/standard quality of the database taken into account completeness of the standard information requirements for the tonnage band.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.302 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 181 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 181 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
For potential dermal exposure, route-to-route extrapolation from the oral NOAEL value was considered appropriate. Since a maximal absorption already occurred by oral route, no additional factor was introduced.
- AF for dose response relationship:
- 1
- Justification:
- The dose-descriptor is a NOAEL. Table R.8-6 ECHA REACH Guidance.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for a sub-acute study. Table R.8-5 ECHA REACH Guidance.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric scaling factor for rats. Table R.8-4 ECHA REACH Guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for other interspecies differences. Table R.8-6 ECHA REACH Guidance.
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population. Table R.8-6 ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor for good/standard quality of the database taken into account completeness of the standard information requirements for the tonnage band
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.603 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 181 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 181 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification of the dose descriptor starting point is required. The endpoint used to derive the DNEL uses the oral route for exposure.
- AF for dose response relationship:
- 1
- Justification:
- The dose-descriptor is a NOAEL. Table R.8-6 ECHA REACH Guidance.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for a sub-acute study. Table R.8-5 ECHA REACH Guidance.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric scaling factor for rats. Table R.8-4 ECHA REACH Guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for other interspecies differences. Table R.8-6 ECHA REACH Guidance.
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for good/standard quality of the database taken into account completeness, consistency and the standard information requirements for the tonnage band.
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor for good/standard quality of the database taken into account completeness of the standard information requirements for the tonnage band
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
NOAEL (systemic toxicity) = 3,000 ppm diet (181 mg/kg bw/d); OECD 422; Anon. (2017)
Long-term systemic hazard assessment for this substance to the general population is based on a sub-acute repeated dose toxicity study, combined with reproduction and developmental screening (OECD 422, Anon., 2017). During the treatment period, a dose-dependent decrease in overall mean body weight gain was apparent in all groups, with a greater extent seen in groups treated at 7500 ppm, of toxicity and recovery phase males and females exposed to the test item when compared to controls; this decrease in overall weight gain was largely attributable to lower body weight gain and body weight losses during Week 1. This coincides with the reduced food intake seen in the first few days of treatment. A similar trend in body weight performance was evident among the reproductive phase females in the gestation and lactation period and was considered to be an adverse effect. Within the scope of this study it was not possible to establish with certainly the aetiology of the potentially adverse reduction in birth weight and subsequent body weight gain of the male offspring in the 3000 and 7500 ppm group and female offspring in the 7500 ppm group. This may have been as a result of the parent females being smaller and consuming less food (thus there being reduced levels of nutrients available to pass to the fetus in utero and reduced quality milk in lactation), or a direct effect ofthe test item by cross‑placental in utero exposure. The reduction in body weight gain of the offspring derived from parent animals given 7500 ppm was considered adverse.
The lowest NOAEL (3,000 ppm diet, equivalent to 181 mg/kg bw/d) was therefore used to derive the general population DNELs in accordance with ECHA Guidance.
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.