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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

Oral (no guideline followed): NOAEL ≥ 3100 mg/kg bw/day (males); NOAEL ≥ 4100 mg/kg bw/day (females);

RA from source substance Monosodium L(+) tartrate (CAS 526 -94 -3)

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
3 100 mg/kg bw/day
Study duration:
chronic
Species:
rat
Quality of whole database:
The available information comprises an adequate, reliable (Klimisch score 2) study from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products and similarities in PC/ECO/TOX properties (refer to endpoint discussion for further details).
Taken together, the information from these independent source is consistent and provides sufficient weight of evidence for hazard assessment leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No. 1907/2006. Therefore, the available information as a whole is sufficient to fulfil the standard information requirements set out in Annex VIII, 8.6, in accordance with Annex XI of Regulation (EC) No. 1907/2006.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Repeated dose toxicity

 

Justification for read-across

There are no measured/experimental data for repeated dose toxicity available for disodium tartrate (CAS 868 -18 -8). To fulfil the standard data requirements defined in Regulation (EC) No. 1907/2006, Annex VIII, 8.6, read-across from an appropriate substance is conducted in accordance with Regulation (EC) No. 1907/2006, Annex XI.

According to Article 13 (1) of Regulation (EC) No. 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met”. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across) “to avoid the need to test every substance for every endpoint”.

 

For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read across, with regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substances are the basis of read-across. A detailed justification for the analogue read- across approach is provided in the technical dossier (see IUCLID Section 13).

 

As no measured/experimental data are available on repeated dose toxicity for disodium tartrate (CAS 868 -18 -8), read-across to reliable data on the analogue substance sodium hydrogen tartrate (CAS 526 -94 -3) was conducted.

 

Repeated dose toxicity (oral)

Repeated dose toxicity was tested in a 2-year toxicity study (Hunter et al., 1977). Groups of 35 male and female Sprague-Dawley rats received daily doses of the test substance via the food at dose levels of 25600, 42240, 60160, 76800 ppm. Mortality, body weight and food intake were recorded. Urinalysis, haematology and clincial chemistry parameters were investigated during weeks 4, 8, 12, 24, 52, 77 and 103 of the study. Further, ophthalmoscopic evaluations, organ weights, gross pathology and histopathological examinations were performed.

The mortality in the treatment group observed during the study period was less than in the control group. After 6 weeks of treatment, animals receiving dose levels of 42240, 60160 and 76800 ppm consistently ate less food than the control group. Thereafter, bodyweight gain of rats treated with 42240, 60160 and 76800 ppm monosodium L(+) tartrate remained depressed.

There was a dosage-related reduction in bodyweight gain of all treated rats during the first 26 weeks of the study. No morphological effects were observed. Based on the lack of adverse effects, a NOAEL ≥ 3100 mg/kg bw/day and ≥ 4100 mg/kg bw/day in males and females (calculation based on the concentration 76800 ppm), respectively, was derived in the conducted study.

Justification for classification or non-classification

Based on the analogue read-across approach, the available data on repeated dose toxicity (oral) do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.