Registration Dossier

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. certificate)
Type of method:
in vitro
Endpoint addressed:
basic toxicokinetics

Test material

Reference
Name:
Unnamed
Type:
Constituent
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.