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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Toxicological Summary

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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
3
Dose descriptor:
NOAEC
Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
281 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
6
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Since only local effects in the respiratory tract were seen in animal studies and no systemic effects could be observed, long-term DNELs were derived for local effects only. The same applies for the carcinogenic potential of diantimony trioxide. Because it can be assumed that particle deposition followed by macrophage infiltration, pulmonary inflammation and impaired clearance are pivotal initial steps in the carcinogenic process, diantimony trioxide can be regarded as a threshold carcinogen and thus no DMEL was derived.

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
5
Dose descriptor:
NOAEC
Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
168.6 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
168.6 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Long-term exposure - systemic effects oral DNEL, children = 16.86 mg/kg bw/day (AF=100)

Long-term exposure - systemic effects dermal DNEL, children = 16.86 mg/kg bw/day (AF=100)

Long-term exposure - local effects inhalation DNEL, consumer = 0.1 mg/m³ (AF=5)

Since only local effects in the respiratory tract were seen in animal studies and no systemic effects could be observed, long-term DNELs were derived for local effects only. The same applies for the carcinogenic potential of diantimony trioxide. Because it can be assumed that particle deposition followed by macrophage infiltration, pulmonary inflammation and impaired clearance are pivotal initial steps in the carcinogenic process, diantimony trioxide can be regarded as a threshold carcinogen and thus no DMEL was derived.