Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.3 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
Modified dose descriptor starting point:
NOAEC
DNEL value:
97.2 mg/m³
Explanation for the modification of the dose descriptor starting point:
In the absence of any data to the contrary, the same bioavailability is assumed for humans and laboratory animals. As no data on effects of repeated inhalation exposure to ammonium perrhenate in humans or laboratory animals are available, route-to-route extrapolation to calculate a DNEL for such effects from a reliable Repeated dose toxicity with Reproductive/Developmental toxicity screening test (OECD TG422) by the oral route in rats was considered a suitable alternative (no high first-pass metabolism has been reported or is expected).
AF for dose response relationship:
1
Justification:
Default AF; human health relevant NOAEL from well-conducted 28-day dietary study. Effects at 330 mg/kg bw/day (increase in thyroid weight in both sexes, and a slight increased incidence of ploughing and excess salivation in males) were not considered severe
AF for differences in duration of exposure:
6
Justification:
Default AF for subacute (28-day) to chronic extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA AF for rats for toxicokinetic differences in metabolic rate (allometric scaling); already considered in modification of starting point above
AF for other interspecies differences:
2.5
Justification:
Default ECHA AF for remaining toxicokinetic differences (not related to metabolic rate) and toxicodynamic differences
AF for intraspecies differences:
5
Justification:
Default ECHA AF for (healthy) worker
AF for the quality of the whole database:
1
Justification:
Default AF; the human health effects data are reliable and consistent, the available information meets the tonnage driven data requirements, and confidence in the database is high
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:
0.4 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
Modified dose descriptor starting point:
NOAEL
DNEL value:
110 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
In the absence of any data to the contrary, the same bioavailability is assumed for humans and laboratory animals. As no data on effects of repeated dermal exposure to ammonium perrhenate in humans or laboratory animals are available, route-to-route extrapolation to calculate a DNEL for such effects from a reliable repeated dose oral toxicity study in rats was considered a suitable alternative (no high first-pass metabolism has been reported or is expected).
AF for dose response relationship:
1
Justification:
Default AF; human health relevant NOAEL from well-conducted 28-day dietary study. Effects at 330 mg/kg bw/day (increase in thyroid weight in both sexes, and a slight increased incidence of ploughing and excess salivation in males) were not considered severe
AF for differences in duration of exposure:
6
Justification:
Default AF for subacute (28-day) to chronic extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
Default ECHA AF for rats for toxicokinetic differences in metabolic rate (allometric scaling)
AF for other interspecies differences:
2.5
Justification:
Default ECHA AF for remaining toxicokinetic differences (not related to metabolic rate) and toxicodynamic differences
AF for intraspecies differences:
5
Justification:
Default ECHA AF for (healthy) worker
AF for the quality of the whole database:
1
Justification:
Default AF; the human health effects data are reliable and consistent, the available information meets the tonnage driven data requirements, and confidence in the database is high
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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.3 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
Modified dose descriptor starting point:
NOAEC
DNEL value:
47.8 mg/m³
Explanation for the modification of the dose descriptor starting point:
In the absence of any data to the contrary, the same bioavailability is assumed for humans and laboratory animals. As no data on effects of repeated inhalation exposure to ammonium perrhenate in humans or laboratory animals are available, route-to-route extrapolation to calculate a DNEL for such effects from the repeated dose oral toxicity study was considered a suitable alternative (no high first-pass metabolism has been reported or is expected).
AF for dose response relationship:
1
Justification:
Default AF; human health relevant NOAEL from well-conducted 28-day dietary study. Effects at 330 mg/kg bw/day (increase in thyroid weight in both sexes, and a slight increased incidence of ploughing and excess salivation in males) were not considered severe
AF for differences in duration of exposure:
6
Justification:
Default AF for subacute (28-day) to chronic extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
Default ECHA AF for rats for toxicokinetic differences in metabolic rate (allometric scaling); already considered in modification of starting point above
AF for other interspecies differences:
2.5
Justification:
Default ECHA AF for remaining toxicokinetic differences (not related to metabolic rate) and toxicodynamic differences
AF for intraspecies differences:
10
Justification:
Default ECHA AF for general population (including children and the elderly)
AF for the quality of the whole database:
1
Justification:
Default AF; the human health effects data are reliable and consistent, the available information meets the tonnage driven data requirements, and confidence in the database is high
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:
no hazard identified
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