Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 000 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):
12.5
Dose descriptor starting point:
NOAEC
AF for interspecies differences (allometric scaling):
2.5
Justification:
After allometric scaling and adjustment of exposure duration as prescribed in table R8.2. of chapter R8 of REACH CSR guidance, a calculated long term inhalatory NOAEC in humans of 12180 mg/m3 is obtained
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
Justification:
Quality of experiment, dose response curve and dataset is considered adequate so no additional AF are used.
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 000 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):
12.5
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - 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

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:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
38 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):
25
Dose descriptor starting point:
NOAEL
DNEL value:
3 785 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
950 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The equivalent human NOAEL after allometric scaling (/4) results in a daily chronic human NOAEL of 946 mg/kg bw/day

AF for interspecies differences (allometric scaling):
4
Justification:
The equivalent human NOAEL after allometric scaling (/4) results in a daily chronic human NOAEL of 946 mg/kg bw/day
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
intraspecies variability within the general population
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Lowest (female) NOAEL obtained in a 2-year chronic rat feeding study with analogue sodium L(+) tartrate results

in 3100 mg/kg/day (3785 as potassium sodium tartrate). The equivalent human NOAEL after allometric scaling

(/4) results in a daily chronic human NOAEL of 946 mg/kg bw/day. According to guidance an interspecies AF of

2.5 is applied and an additional AF of 10 for intraspecies variability within the general population is also applied,

leading to a global AF of 25. This results in an estimated DNEL of 946/25 = 38 mg/kg bw/day for chronic

exposure to the reference substance (anhydrous). Expressed in terms of tartaric acid this is equivalent to 27 mg/kg

bw/day.

Oral exposure is considered to be the most relevant route of exposure of the general public to the reference

substance, as it is a common food additive and a natural component of some fruits, juices and wine. No oral

exposure other than accidental is expected from the identified non food-uses. Food additive uses and exposure are

not described herein or in the CSR as this use is exempted from the scope of REACH and duly covered elsewhere.

It is worth mentioning that the proposed value is very similar to that cited in EU report COM(2001) 542 final on

"Dietary Food Additive Intake in the European Union" which indicates an EU accepted ADI (Allowable daily

intake value) for sodium tartrate and potassium sodium tartrate of 30 mg/kg day (expressed as tartaric acid), which

coincides with the JECFA value proposed in 1973.

Identified uses do not suggest the likelihood of intoxication of the general public with the substance. The high rat

LD50 values > 3 g/kg, which after allometric scaling place the hypothetical human LD50 close to 50 g/ adult, do

not suggest the need to derivate an acute oral DNEL.

The substance is not considered an eye or a skin irritant, although mild eye irritation may occur in exposed

individuals, as well as after prolonged dermal exposure. No DNEL can be derived for these endpoints.