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EC number: 239-931-4 | CAS number: 15827-60-8
- 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:
- 7.27 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):
- 10
- Dose descriptor starting point:
- NOAEL
- Value:
- 82.5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 72.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEL (oral): Correction respiratory volume rat (8 hour) 1/0.38 m³/kg bw/day, Correction for respiratory volume (worker): 6.7 m³/10 m³. Correction for oral to inhaled 1/2. Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: oral 82.5*(1/0.38) *(6.7 m³/10 m³)*(1/2) = 72.7 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (oral rat to inhaled human)
- AF for other interspecies differences:
- 1
- Justification:
- The effects observed in the oral study were indicative of the iron binding capacity of the test substance and its influence on calcium homeostasis, however, without causing any changes in calcium plasma levels, therefore no intraspecies differenced apply.
- AF for intraspecies differences:
- 5
- Justification:
- Default (worker)
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- other: VCI, Verband der Chemischen Industrie e.V. (2010): Ableitung von DNEL für lokal reizende Stoffe mit guter Datenlage zur systemischen Toxizität, aber limitierter Datenlage zur Inhalationstoxizität.
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:
- 8.25 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):
- 20
- Dose descriptor starting point:
- NOAEL
- Value:
- 82.5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 165 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Measured data are available for DTPMP acid, which indicate that oral absorption is around 2% and dermal absorption is <1%. The following correction was made for the NOAEL (oral): Correction for absorption 2/1. Therefore, the corrected NOAEL for repeated-dose systemic effects via the dermal route is: 82.5*(2/1) = 165 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 2
- Justification:
- The effects observed in the oral study were indicative of the iron binding capacity of the test substance and its influence on calcium homeostasis, however, without causing any changes in calcium plasma levels. Therefore, the proposed assessment factor for interspecies differences is 2.
- AF for other interspecies differences:
- 1
- Justification:
- The effects observed in the oral study were indicative of the iron binding capacity of the test substance and its influence on calcium homeostasis, however, without causing any changes in calcium plasma levels, therefore no intraspecies differenced apply.
- AF for intraspecies differences:
- 5
- Justification:
- Default (worker)
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
DNELs for workers long-term systemic effects via the inhalation and dermal routes were derived from a good quality 90-day feeding study (reliability score 1) conducted to OECD 408 and GLP, groups of 12 male and 12 female Wistar-derived rats were fed diets containing 0 (control), 100, 1000 or 10000 ppm (equivalent to 8.2, 82.5 and 841.9 mg/kg bw/day in males and 9.2, 92.3 and 902.6 mg/kg for females) test material for 90 consecutive days. Clinical observations, bodyweights and food consumption were measured. Ophthalmoscopic and haematology examinations, clinical chemistry and urinalysis were conducted. At the end of the exposure period all animals were killed and a full microscopic examination conducted. Bone mineral density was evaluated for bone collected at termination. There were no deaths and the majority of parameters were unaffected by the treatment. Minor changes in certain haematological parameters (red blood cell count was significantly increased, mean cell volume and mean cell haemoglobin concentration were significantly decreased) were noted at the highest dose. There was also a decreased incidence in Perls' staining of the spleen. It is unlikely that DTPMP exerts a true systemic effect and the observed anaemia is much more likely to be due to inhibition of iron uptake in the gastrointestinal tract.
Bone density was significantly increased in both sexes in the highest dose group, and the incidence of microlithiasis in the kidney was reduced at all dose levels. These changes are indicative of the influence of the test material on calcium homeostasis, however, without causing any changes in calcium plasma levels. Therefore, the changes were not considered to be of toxicological significance, and the NOAEL was 1000 ppm (equivalent to to 82.5 and 92.3 mg/kg bw/day of active acid in males and females, respectively).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.8 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):
- 20
- Dose descriptor starting point:
- NOAEL
- Value:
- 82.5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 35.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEL (oral): Correction respiratory volume rat (24 hour) 1/1.15 m³/kg bw. Correction for oral to inhaled 1/2. Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 82.5*(1/1.15)*(1/2) = 35.9 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (oral rat to inhaled human)
- AF for other interspecies differences:
- 1
- Justification:
- The effects observed in the oral study were indicative of the iron binding capacity of the test substance and its influence on calcium homeostasis, however, without causing any changes in calcium plasma levels, therefore no intraspecies differenced apply.
- AF for intraspecies differences:
- 10
- Justification:
- Default (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- other: VCI, Verband der Chemischen Industrie e.V. (2010): Ableitung von DNEL für lokal reizende Stoffe mit guter Datenlage zur systemischen Toxizität, aber limitierter Datenlage zur Inhalationstoxizität.
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:
- 4.1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 82.5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 165 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Measured data are available for DTPMP acid, which indicate that oral absorption is around 2% and dermal absorption is < 1%. The following correction was made for the NOAEL (oral): Correction for absorption 2/1. Therefore, the corrected NOAEL for repeated -dose systemic effects via the dermal route is: 82.5*(2/1) = 165 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 2
- Justification:
- The effects observed in the oral study were indicative of the iron binding capacity of the test substance and its influence on calcium homeostasis, however, without causing any changes in calcium plasma levels. Therefore the proposed assessment factor for interspecies differences is 2.
- AF for other interspecies differences:
- 1
- Justification:
- The effects observed in the oral study were indicative of the iron binding capacity of the test substance and its influence on calcium homeostasis, however, without causing any changes in calcium plasma levels, therefore no intraspecies differenced apply.
- AF for intraspecies differences:
- 10
- Justification:
- Default (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- 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:
- 2.1 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):
- 40
- Dose descriptor starting point:
- NOAEL
- Value:
- 82.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No correction was applied to the dose descriptor starting point.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 2
- Justification:
- The effects observed in the oral study were indicative of the iron binding capacity of the test substance and its influence on calcium homeostasis, however, without causing any changes in calcium plasma levels. Therefore the proposed assessment factor for interspecies differences is 2.
- AF for other interspecies differences:
- 1
- Justification:
- Since the effect was most likely to have been caused by inhibition of iron uptake in the gastrointestinal tract (i.e. a local physicochemical effect in the gut), no allometric scaling or assessment factor for interspecies differences were included in the DNEL calculation. This is justified by the fact that test species used (rats) are more susceptible to iron deficiencies than humans and other standard laboratory species.
- AF for intraspecies differences:
- 10
- Justification:
- Defalut (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
DNELs for general population long-term systemic effects via the inhalation, dermal and oral routes were derived from a 90-day feeding study (reliability score 1) conducted according to OECD 408 guideline and the principles of GLP, groups of 12 male and 12 female Wistar-derived rats were fed diets containing 0 (control), 100, 1000 or 10000 ppm (equivalent to 8.2, 82.5 and 841.9 mg/kg bw/day in males and 9.2, 92.3 and 902.6 mg/kg for females) test material for 90 consecutive days. Clinical observations, bodyweights and food consumption were measured. Ophthalmoscopic and haematology examinations, clinical chemistry and urinalysis were conducted. At the end of the exposure period all animals were killed and a full microscopic examination conducted. Bone mineral density was evaluated for bone collected at termination. There were no deaths and the majority of parameters were unaffected by the treatment. Minor changes in certain haematological parameters (red blood cell count was significantly increased, mean cell volume and mean cell haemoglobin concentration were significantly decreased) were noted at the highest dose. There was also a decreased incidence in Perls' staining of the spleen. It is unlikely that DTPMP exerts a true systemic effect and the observed anaemia is much more likely to be due to inhibition of iron uptake in the gastrointestinal tract.
Bone density was significantly increased in both sexes in the highest dose group, and the incidence of microlithiasis in the kidney was reduced at all dose levels. These changes are indicative of the influence of the test material on calcium homeostasis, however, without causing any changes in calcium plasma levels.
Therefore, the changes were not considered to be of toxicological significance, and the NOAEL was 1000 ppm (equivalent to to 82.5 and 92.3 mg/kg bw/day of active acid in males and females, respectively).
The calculated DNELs are valid for both the acid and salt DTPMP substances since once absorbed the DTPMP salts will dissociate to become the acid and counter-ion, while the counter-ion is not expected to exhibit or influence toxicity.
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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