Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is highly insoluble in water, hence indicating that aquatic toxicity is unlikely to occur
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
transformation / dissolution of metals and inorganic metal compounds
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-09-07 to 2010-04-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
deviations from the guideline, which do not effect the validity of the study: (a) the 28-day test with a loading of 1 mg/L was conducted at pH 6 instead of 5.5 (b) `mass balance (%) after completion of the transformation test´ is missing.
Qualifier:
according to
Guideline:
OECD Series on Testing and Assessment No. 29 (23-Jul-2001): Guidance document on transformation/dissolution of metals and metal compounds in aqueous media
Deviations:
yes
Remarks:
please refer to the field "Rationale for reliability incl. deficiencies" above
GLP compliance:
yes (incl. certificate)
Remarks:
signed 2009-06-19
Type of method:
flask method
Remarks:
transformation/dissolution
Type of test:
screening transformation/dissolution test - sparingly soluble metal compounds
Mean dissolved conc.:
< 0.5 µg/L
Element analysed:
Cr, Al
Loading of aqueous phase:
0.1 g/L
Incubation duration:
24 h
Test conditions:
pH: >= 6.08 <= 6.1
Temp: 22.5 °C
Remarks on result:
other: < LOD
Type of test:
screening transformation/dissolution test - sparingly soluble metal compounds
Mean dissolved conc.:
< 0.5 µg/L
Element analysed:
Cr, Al
Loading of aqueous phase:
0.1 g/L
Incubation duration:
24 h
Test conditions:
pH: >= 8.04 <= 8.08
Temp.: 22.5 °C
Remarks on result:
other: < LOD
Type of test:
full transformation/dissolution test - metals and sparingly soluble metal compounds
Mean dissolved conc.:
< 0.5 µg/L
Element analysed:
Cr
Loading of aqueous phase:
0.1 g/L
Incubation duration:
7 d
Test conditions:
pH: >= 6.07 <= 6.11
Temp.: 22.5 °C
Remarks on result:
other: < LOD
Type of test:
full transformation/dissolution test - metals and sparingly soluble metal compounds
Mean dissolved conc.:
2.4 µg/L
Element analysed:
Al
Loading of aqueous phase:
0.1 g/L
Incubation duration:
7 d
Test conditions:
pH: >= 6.07 <= 6.11
Temp.: 22.5 °C
Remarks on result:
other: SD: +/- 0.4 µg/L
Type of test:
full transformation/dissolution test - metals and sparingly soluble metal compounds
Mean dissolved conc.:
< 0.05 µg/L
Element analysed:
Cr, Al
Loading of aqueous phase:
1 mg/L
Incubation duration:
24 h
Test conditions:
pH: >=6.05<=6.12, Temp.: 22.5 °C
Remarks on result:
other: < LOD
Key result
Type of test:
full transformation/dissolution test - metals and sparingly soluble metal compounds
Mean dissolved conc.:
< 0.5 µg/L
Element analysed:
Cr, Al
Loading of aqueous phase:
1 mg/L
Incubation duration:
7 d
Test conditions:
pH >= 6.07 <= 6.08, Temp.: 22.5 °C
Remarks on result:
other: < LOD
Key result
Type of test:
full transformation/dissolution test - metals and sparingly soluble metal compounds
Mean dissolved conc.:
< 0.5 µg/L
Element analysed:
Cr, Al
Loading of aqueous phase:
1 mg/L
Incubation duration:
28 d
Test conditions:
pH: >= 6.04 <= 6.06
Temp.: 22.5 °C
Remarks on result:
other: < LOD
Details on results:
The analytical method was shown to be suitable for low content determination of chromium and aluminium in aqueous samples due to the technique ICP-MS.
The analysed range from 0.1 to 10.0 µg/L was found to be linear for Cr and Al (correlation coefficient > 0.99 for either metal).
The instrumental limit of detection (I.D.L.) defined as the lowest calibration level, was 0.1 µg/L for Cr and Al, respectively.
The limit of quantification (L.O.Q.) of the method was 1 µg/L for Cr and Al, defined as the lowest fortification level.
The limit of detection (L.O.D.) of the method, defined as 50% of the lowest fortification level, was 0.5 µg/L for either metal.
Concentrations higher than the limit of detection but less than the limit of quantification were designated as <1 µg/L for Cr and Al.
The analytical method was shown to be suitable for low content determination of chromium and aluminium in aqueous samples due to the technique ICP-MS.
The test was performed by spiking each of the test media (using three replicates) with known amounts of Cr and Al at two fortification levels (1 µg/L for the low level and 10 µg/L for the high level) using the SS 2 and SS 1 solution of 1 mg/L and 10 mg/L, respectively.
For precision, the SANCO/3029/99 rev. 4 guideline requires a RSD % lower than 20 % for each fortification level; therefore the precision of the analytical method at low and high fortification levels can be considered acceptable.
The precision of the analytical method has been fixed at 10 % taking into account the results obtained.
For accuracy, the SANCO/3029/99 rev. 4 guideline requires individual recovery values in the range from 70 to 110 % with mean value between 80 to 100 % at each fortification level, therefore the accuracy of the analytical method can be considered acceptable.
Considering the low concentrations tested (low fortification level 1 µg/L and high fortification level 10 µg/L), the precision of the analytical method fixed at 10 % and the complexity of the aqueous matrices tested the accuracy of the analytical method can be considered acceptable.
From the data and results of the accuracy test it can be concluded that no matrix effect was observed and no contribution of the filter procedure was observed.

Screening Test

at 0.1 g/L

 

52Cr (µg/L)

27Al (µg/L)

pH 6 T 24 h

Mean

n.d.

n.d.

S.D.

-

-

RSD %

-

-

pH 8 T 24 h

Mean

n.d.

n.d.

S.D.

-

-

RSD %

-

-

Conclusion of the screening test:

Dissolved Al or Cr concentrations were below the LOD at both pH levels. Therefore, pH 6 was selected for the full test assuming that the dissolution of metal oxides (i.e. this pigment) is maximized at the lower pH (in acidic medium).

Full Test 7 days

at 0.1 g/L pH 6

 

52Cr (µg/L)

27Al (µg/L)

T 1 day

Mean

n.d.

3.9

S.D.

-

0.04

RSD %

-

1.0 %

T 4 days

Mean

n.d.

3.739

S.D.

-

0.113

RSD %

-

3.02 %

T 7 days

Mean

n.d.

2.414

S.D.

-

0.389

RSD %

-

16.13 %

Full Test 28 days

at 1 mg/L pH6

 

52Cr (µg/L)

27Al (µg/L)

T1 day

Mean

n.d.

n.d.

S.D.

-

-

RSD %

-

-

T7 days

Mean

n.d.

n.d.

S.D.

-

-

RSD %

-

-

T14 days

Mean

n.d.

n.d.

S.D.

-

-

RSD %

-

-

T28 days

Mean

n.d.

n.d.

S.D.

-

-

RSD %

-

-

Test conditions:

- The pH was inside of the acceptable range (pH6 +0.2 units) in a range of 6.02 to 6.10

- The temperature was inside of the acceptable range (20 -25 +/- 2) in a range of 22.4 to 22.6

- The O2 -concentration was always above the accaptable limit of 70 % in a range of 79.7 % to 81.7 %

- The within-vessel values and the between-vessel values could not be determined, because the concentrations of Cr and Al were below the LOD (0.5 µg/L for Al and Cr)

Conclusions:
The transformation/dissolution of test item hematite chromium green black is in most cases below the L.O.D. (< 0.5 µg/L) at pH 6.

- after 7 days, 1 mg/L: < 0.5 µg Cr/L, <0.5 µg Al/L
- after 28 days, 1 mg/L: < 0.5 µg Cr/L, < 0.5 µg Al/L
- after 7 days, 100 mg/L: < 0.5 µg Cr/L, 2.4 µg Al/L

Thus, this pigment is considered environmentally inert.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion