Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Additional information - workers

An oral DNEL for workers (relevant to ingestion following inhalation of dusts and aerosols) has been calculated.

The DNEL is 3.9 mg active acid/kg bw/day based on anaemia observed in repeated dose toxicity studies. The starting NOAEL is 38.7 mg active acid/kg bw/day with an assessment factor of 2 applied for duration and an assessment factor of 5 applied for intraspecies differences. 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.

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.

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
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:
1.9 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.9 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Additional information - General Population

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.