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Justification for Cross Reading “B-stof” and “Complexation products of sodium tartrate with iron trichloride”

 

The purity and identity of “Complexation products of sodium tartrate with iron trichloride” was determined by analysis. The overall analyzed composition and the overall composition related are described in section 1.4 of the IUCLID5.

 

The substance is produced as 35% solution in water. It is marketed as 65% or 90-92% aqueous solution.Part of the water can be removed without affecting the stability of the substance, 13% water has to remain for the stability of the complex. The composition after water removal is shown in table 1. The “Complexation products of sodium tartrate with iron trichloride” is defined as an UVCB substance (substance of unknown variable composition, complex reaction products or biological materials).

 

Prior to the development of “Complexation products of sodium tartrate with iron trichloride“ the registrant produced a very similar product named “B-stof”. The composition of both substances is shown below (Table 1).

 

B-stof was defined as a substance with multiple constituents and the different constituents were defined and named. For REACH, elaborate measurements were performed to define the new substance “Complexation products of sodium tartrate with iron trichloride” and these measurements showed that the new substance did not consist of multiple constituents but that these constituents actually form a complex. These measurements were never performed for B-stof.

 

 

Table 1. Composition of “Reaction products of iron trichloride and sodium hydroxide and L-tartaric acid“ and “B-stof” with water

 

With water

Complexation products of sodium tartrate with iron trichloride

B-Stof

 

CAS

%

%

Complexation products of sodium tartrate with iron trichloride

NA

56.4

 

Iron chloride

7705-08-0

 

1.1

Levotartaric acid

147-71-7

 

4

Racemic acid (L and D)

133-37-9

 

6

Ethanedioic acid

144-62-7

0.6

 

Sodium chloride

7647-14-5

30.1

10.8

Water

7732-18-5

12.9

78.1

 

Total

100

100

 

The two substances are therefore actually very similar in composition and study results obtained with B-stof can be used to fill the endpoints for“Complexation products of sodium tartrate with iron trichloride“. If you look at the composition without water in Table 2 you see that the constituents that arelisted for the B-stof separately as Iron chloride,Levotartaric acid andRacemic acid (L and D) add up to (5 +18.3+27.4=) 50.7%. Under the new substance definition this would be 50.7% “Complexation products of sodium tartrate with iron trichloride”.The currently produced substance contains 64.8% “Complexation products of sodium tartrate with iron trichloride“.

Table 2. Composition of “Reaction products of iron trichloride and sodium hydroxide and L-tartaric acid“ and “B-stof” without water

 

Without water

Complexation products of sodium tartrate with iron trichloride

B-Stof

 

CAS

%

%

Complex of iron and sodium hydroxide and D-, L-, and mesotartaric acid

NA

64.8

 

Iron chloride

7705-08-0

 

5

Levotartaric acid

147-71-7

 

18.3

Racemic acid (L and D)

133-37-9

 

27.4

Sodium chloride

7647-14-5

34.5

49.3

Ethanedioic acid

144-62-7

0.7

 

 

Total

100

100

 

 

If any, toxicity caused by this substance will most likely be related to the tartaric acid. This is the main constituent of the UVCB.Ethanedioic acid is classified as harmful in contact with skin and eyes ≥ 5%. Sodium chloride and iron are not considered toxic at these low levels.

Furthermore an acute toxicity study with fish shows an LC 50 > 1000 mg/L for “Complexation products of sodium tartrate with iron trichloride“ supporting the results for other aquatic species reported for B-stof.