Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.2 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
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:
DNEL (Derived No Effect Level)
Value:
2.9 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

There are two NOAELs here; NOAEL of repeated dose toxicity is 2460 mg/kg bw/day and NOAEL of reproductive toxicity is 181 mg/ka bw/day. For guaranteeing safety, the latter is chosen as the start point of dose descriptor. Retrospect to the details in such reproductive toxicological study, the Teratogenicity of tartaric acid in rat was studied using prenatal developmental toxicity test, and no teratogenic effect was generated after oral administered tartaric acid in rat. Besides, it needs to be noticed that only one dosing was used in such tests. Thus it is strongly implied that such assessment is somewhat conservative.

The absorption rates used here was obtained from the study of DL-tartrate, which is a mixture of L(+) - tartrate and D(-) - tartrate. So the calculation would be more accurate if values from an L (+) - tartaric acid study are available.

General Population - 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:
developmental toxicity / teratogenicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEC
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:
DNEL (Derived No Effect Level)
Value:
1.5 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
DNEL related information
Overall assessment factor (AF):
100
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:
8.1 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

There are two NOAELs here; NOAEL of repeated dose toxicity is 2460 mg/kg bw/day and NOAEL of reproductive toxicity is 181 mg/ka bw/day. For guaranteeing safety, the latter is chosen as the start point of dose descriptor. Retrospect to the details in such reproductive toxicological study, the Teratogenicity of tartaric acid in rat was studied using prenatal developmental toxicity test, and no teratogenic effect was generated after oral administered tartaric acid in rat. Besides, it needs to be noticed that only one dosing was used in such tests. Thus it is strongly implied that the assessment is somewhat conservative.

The absorption rates used here was obtained from the study of DL-tartaric acid, which is a mixture of L(+) - tartrate and D(-) - tartrate. So the calculation would be more accurate if values from an L (+) - tartaric acid study are available.