Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 230-794-6 | CAS number: 7321-53-1
- 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:
- 4.9 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:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NAEC
- Value:
- 367.5 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 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 highest dose administered to treatment animals was 300 mg/kg bw/day, which resulted to be non toxic neither for repeated expoure nor for reproductive/developmental parameters. Therefore, the NOAEL value is considered 300 mg/kg bw/day.
To calculate the DNEL it is necessary first to calculate the NAECworkers, inhalation applying the following formula:
NAECworkers, inhalation= NOAELrat, oral÷ 4 × 70 kg ÷ 10 m3× 1.4 × 0.5 = 300 mg/kg bw/day ÷ 4 × 70 kg ÷ 10 m3× 1.4 × 0.5 = 367.5 mg/m3
As the NOAEL value was particular to rats, it is necessary to apply an factor of 4 to consider inter-species differences; the standard body weight considered for workers is 70 kg, therefore, the NOAEL 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 NOAEL 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 NOAEL value is multiplied by 0.5 to account for absorption differences.
The DNELworkers was then calculated as follows:
DNELworkers, inhalation = NAECworkers,inhalation/Overall AF = 367.5 mg/m3 / 75 = 4.9 mg/m3
The overall assessment factors (AF) is calculated multiplying the AFs detailed below.
- AF for dose response relationship:
- 1
- Justification:
- AF for dose response relationship is considered 1 as the source study uses a NOAEL
- 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 (63-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 NOAEL 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:
- no hazard identified
- 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:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14 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:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4 200 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 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 dermal route. The most sensitive value was found in the Reproductive/Developmental Screening Test combined with Repeated Dose Toxicity test.
The highest dose administered to treatment animals was 300 mg/kg bw/day, which resulted to be non toxic neither for repeated expoure nor for reproductive/developmental parameters. Therefore, the NOAEL value is considered 300 mg/kg bw/day.
To calculate the DNEL it is necessary first to calculate the NOAECworkers, dermal applying the following formula:
NOAELworkers, dermal= NOAELrat, oral × 1.4 /0.1 = 4200 mg/kg bw
A worker is considered to be exposed to a substance for 5 days out of 7, therefore, the NOAEL value is multiplied by a factor of 1.4.
A default value of 100 % skin absorption is allocated to substances with a molar mass below 500 and a partition coefficient between log Pow-1 and 4. In the case of iron tris(2 -ethylhexanoate) the molecular mass and/or partition coefficient values are outside the given range, therefore a skin absorption value of 10 % is allocated.
The DNELworkers, dermal was then calculated as follows:
DNELworkers, dermal= NOAECworkers,dermal/Overall AF = 4200 mg/kg bw/ 300 = 14 mg/kg bw
The overall assessment factors (AF) is calculated multiplying the AFs detailed below.
- AF for dose response relationship:
- 1
- Justification:
- AF for dose response relationship is considered 1 as the source study uses a NOAEL
- 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 (63-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:
- no hazard identified
- 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:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
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:
- 0.75 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:
- NOAEC
- Value:
- 300 mg/m³
- Modified dose descriptor starting point:
- other: NAEC
- Value:
- 112.5 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 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 highest dose administered to treatment animals was 300 mg/kg bw/day, which resulted to be non toxic neither for repeated expoure nor for reproductive/developmental parameters. Therefore, the NOAEL value is considered 300 mg/kg bw/day.
To calculate the DNEL it is necessary first to calculate the NAEChuman, inhalationapplying the following formula:
NAEChuman, inhalation= NOAELrat, oral÷ 4 × 60 kg ÷ 20 m3× 0.5 = 300 mg/kg bw/day ÷ 4 × 60 kg ÷ 20 m3× 0.5 = 112.5 mg/m3
As the NOAEL value was particular to rats, it is necessary to apply an factor of 4 to consider inter-species differences; the standard body weight considered for the general population is 60 kg, therefore, the NOAEL is multiplied by a factor of 60 kg. A person is considered to be exposed to 20 m3 for 24 hours per day for 7 days a week, therefore, the NOAEL 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 NOAEL value is multiplied by 0.5 to account for absorption differences.
The DNELhumans was then calculated as follows:
DNELhumans, inhalation= NAEChumans,inhalation/Overall AF = 112.5 mg/m3/ 150 = 0.75 mg/m3
The overall assessment factors (AF) is calculated multiplying the AFs detailed below.
- AF for dose response relationship:
- 1
- Justification:
- AF for dose response relationship is considered 1 as the source study uses a NOAEL
- 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 (63-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 NOAEL 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:
- no hazard identified
- 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:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 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:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 3 000 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 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 dermal route. The most sensitive value was found in the Reproductive/Developmental Screening Test combined with Repeated Dose Toxicity test.
The highest dose administered to treatment animals was 300 mg/kg bw/day, which resulted to be non toxic neither for repeated expoure nor for reproductive/developmental parameters. Therefore, the NOAEL value is considered 300 mg/kg bw/day.
To calculate the DNEL it is necessary first to calculate the NOAEChumans, dermalapplying the following formula:
NOAELhumans, dermal= NOAELrat, oral/0.1 = 3000 mg/kg bw
A default value of 100 % skin absorption is allocated to substances with a molar mass below 500 and a partition coefficient between log Pow-1 and 4. In the case of iron tris(2 -ethylhexanoate) the molecular mass and/or partition coefficient values are outside the given range, therefore a skin absorption value of 10 % is allocated.
The DNELhumans, dermalwas then calculated as follows:
DNELhumans, dermal= NOAEChumans,dermal/Overall AF = 3000 mg/kg bw/ 600 = 5 mg/kg bw
The overall assessment factors (AF) is calculated multiplying the AFs detailed below.
- AF for dose response relationship:
- 1
- Justification:
- AF for dose response relationship is considered 1 as the source study uses a NOAEL
- 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 (63-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:
- no hazard identified
- 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:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 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:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL 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 highest dose administered to treatment animals was 300 mg/kg bw/day, which resulted to be non toxic neither for repeated expoure nor for reproductive/developmental parameters. Therefore, the NOAEL value is considered 300 mg/kg bw/day.
The overall assessment factors (AF) is calculated multiplying the AFs detailed below.
- AF for dose response relationship:
- 1
- Justification:
- AF for dose response relationship is considered 1 as the source study uses a NOAEL
- 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 (63-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.