Chrome antimony titanium buff rutile

Specific investigations: other studies

Administrative data

Endpoint:

chemobiokinetics general studies

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Principles of method if other than guideline:

An internationally agreed guideline does not exist for this test (e.g. OECD). However, similar tests have been conducted with several metal compounds incl. steels in previous risk assessments (completed under Regulation (EEC) No 793/93) [6] or in recent preparation for REACH regulation (EC) No 1907/2006.
Therefore, the test will be performed on the basis of the guidance for OECD-Series on testing and assessment Number 29 [4] and bioaccessibility test protocols according to different literature.
Test conditions: Two artificial physiological media, one single loading of the test substance, i.e. 100 mg/L, measurements of dissolved nickel and antimony concentrations after 2 and 24 hours of agitation at 37°C (temperature of the media should be in the range 37 ± 2°C).

GLP compliance:

yes (incl. QA statement)

Type of method:

in vitro

Endpoint addressed:

basic toxicokinetics

Test material

Test material information

Constituent 1

Reference substance name:

Chrome antimony titanium buff rutile

EC Number:

269-052-1

EC Name:

Chrome antimony titanium buff rutile

Cas Number:

68186-90-3

Molecular formula:

(Ti, Sb, Cr) O2

IUPAC Name:

manganese(4+) trititanium(4+) pentaantimony(3+) chromium(3+) nickel(2+) octadecaoxidandiide

Test material form:

solid

Details on test material:

Chemical identity: Chrome antimony titanium buff rutile

Administration / exposure

Analytical verification of doses or concentrations:

yes

Duration of treatment / exposure:

2h and 24h

Doses / concentrations

Dose / conc.:

100 mg/L drinking water

Remarks:

nominal, 37°C, due to weighing uncertainties the actual loadings range from 100.006 mg/L to 100.068 mg/L in the 6 test vessels

Results and discussion

Any other information on results incl. tables

The tables show the corrected concentrations, corresponding to a loading of exactly 100 mg/L and the not corrected concentrations according to the actual loadings (with and without method blank subtraction if method blanks above LOQ).

 

Table1:     Concentration of dissolved chromium in artificial physiological media.

media and sample	LOD/LOQ of Cr measurement series	total Cr ± SD in method blanks	Without method blank subtraction		With mean method blank subtraction (mean of 2h and/or 24h)
			total Cr ± SD in sample vessels without method blank	total Cr ± SD in sample vessels (corrected concentrations, corresponding to a loading of exactly 100 mg/L)	total Cr ± SD in sample vessels	total Cr ± SD in sample vessels (corrected concentrations, corresponding to a loading of exactly 100 mg/L)
GST 2h	LOD: 0.003 µg/L LOQ: 0.008 µg/L	All method blanks below LOD	0.209± 0.013 µg/L	0.209± 0.013 µg/L	No subtraction	No subtraction
GST 24h	LOD: 0.003 µg/L LOQ: 0.008 µg/L	0.013µg/L – three method blanks below LOD, one method blank above LOQ	0.470± 0.029 µg/L	0.470± 0.029 µg/L	0.458± 0.027 µg/L	0.458± 0.029 µg/L
ASW 2h	LOD: 0.015 µg/L LOQ: 0.044 µg/L	All method blanks below LOD	0.057 µg/L – four sample below LOD, one sample below LOQ, one sample above LOQ	0.057 µg/L	No subtraction	No subtraction
ASW 24h	LOD: 0.015 µg/L LOQ: 0.044 µg/L	All method blanks below LOD	Five samples below LOD, one sample below LOQ	-	No subtraction	No subtraction

 

Table2:     Concentration of dissolved antimony in artificial physiological media.

media and sample	LOD/LOQ of Sb measurement series	total Sb ± SD in method blanks	Without method blank subtraction		With mean method blank subtraction (mean of 2h and/or 24h)
			total Sb ± SD in sample vesselswithout method blank	total Sb ± SD in sample vessels(corrected concentrations, corresponding to a loading of exactly 100 mg/L)	total Sb ± SD in sample vessels	total Sb ± SD in sample vessels(corrected concentrations, corresponding to a loading of exactly 100 mg/L)
GST 2h	LOD: 0.005 µg/L LOQ: 0.015 µg/L	three method blanks below LOD, one method blank below LOQ	0.453± 0.096 µg/L	0.453± 0.096 µg/L	No subtraction	No subtraction
GST 24h	LOD: 0.005 µg/L LOQ: 0.015 µg/L	three method blanks below LOD, one method blank below LOQ	0.747± 0.039 µg/L	0.747± 0.039 µg/L	No subtraction	No subtraction
ASW 2h	LOD: 0.005 µg/L LOQ: 0.016 µg/L	All method blanks below LOQ	0.504± 0.025 µg/L	0.504± 0.025 µg/L	No subtraction	No subtraction
ASW 24h	LOD: 0.005 µg/L LOQ: 0.016 µg/L	Two method blanks below LOD, thwo method blanks below LOQ	1.79± 0.12 µg/L	1.79± 0.12 µg/L	No subtraction	No subtraction

 

 

 

 

 

Applicant's summary and conclusion

Conclusions:

After substraction of the blank, the release of Sb in GST and ASW after 2h and 24h, respectively, is zero.
After substraction of the blank, the release of Cr in GST after 24h is ~ 0.5 ug/l. No leaching was observed for ASW and GST after 2h.