Registration Dossier
Registration Dossier
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EC number: 252-156-6 | CAS number: 34690-00-1
Toxicological Summary
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
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
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:
- 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:
- 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
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
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