Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Environmental fate & pathways

Bioaccumulation: aquatic / sediment

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
bioaccumulation in aquatic species: fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2007-09-14 to 2007-12-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 305 B (Bioaccumulation: Semi-static Fish Test)
Version / remarks:
1996
Deviations:
no
GLP compliance:
yes
Details on sampling:
- Samples method: Samples from both test solutions and test organisms were taken daily from the 26th day to the last day during the exposure test period. The samples from test organisms were treated by extracting their lipid component that was collected from the test fish, and the extracted solutions of the test substance were obtained. The concentrations of the test substance in exposure solutions and extracted solutions were measured.
Vehicle:
no
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish
- Source: Amazonas Commercial Aquarium, Shanghai
- Mean body length: 2.54 ± 0.11 cm
- Mean body weight: 0.25 ± 0.06 g
- Feeding during test: No

ACCLIMATION
- Acclimation period: One week
- Acclimation conditions: Prior to the test start, the fish were acclimated under conditions of water quality and illumination similar to those used in the test.
- Type and amount of food: During holding and acclimatization until one day before the start of the test the fish were fed with a commercial fish diet.
- Health during acclimation: No mortality was observed during the acclimatation period. During holding and acclimatization no fish died in the test fish batch and all fish were healthy.
Route of exposure:
aqueous
Test type:
semi-static
Water / sediment media type:
natural water: freshwater
Total exposure / uptake duration:
28 d
Hardness:
10 - 250 mg CaCO3 per liter
Test temperature:
23 ± 1 °C
pH:
The pH values in the treatments and the controls ranged from 7.44 to 8.05
Dissolved oxygen:
the dissolved oxygen concentration was always 80 % or higher
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass vessel
- Type: open
- Volume: 15 L
- Renewal rate of test solution (frequency/flow rate): 2 days
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control / vehicle control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated drinking water is used in the test.
- Holding medium different from test medium: no
- Intervals of water quality measurement: The dissolved oxygen concentration, the pH and temperature in the controls and the test
solutions should be measured once every two days during the test.
- Intervals of test medium replacement: 2 days

OTHER TEST CONDITIONS No
- Adjustment of pH: No
- Photoperiod: light-dark cycle was 12h: 12h.

RANGE-FINDING / PRELIMINARY STUDY
Not performed

Nominal and measured concentrations:
- Nominal concentration: 0 (control), 5 and 50 mg/L
- Measured concentration (mean): 6.2 and 59.1 mg/L from the first day to the third dayof sampling.
Reference substance (positive control):
yes
Key result
Conc. / dose:
5 mg/L
Type:
BCF
Value:
< 0.05 dimensionless
Key result
Conc. / dose:
50 mg/L
Type:
BCF
Value:
< 0.46 dimensionless
Results with reference substance (positive control):
The sensitivity of the Brachydanio rerio and conformity with the procedure were supported by the result of the reference substance, δ-666 standard solution. The BCF of δ-666 standard solution was calculated as 2.1 x 10E4 which fulfilled the criteria for a valid test that the BCF of δ-666 standard solution should range in 1.5 x 10E4~3.0 x 10E4.
Details on results:
In the controls and the treatments at the treatment of 50 and 5 mg/L (mean measured concentration 59.1 and 6.2 mg/L) no fish death was determined during the limit test period of 28 days. Based on the measured concentrations in the exposure test medium and the test organism, the bioconcentration factor (BCF) of the test substance to zebra fish was calculated as < 0.05 and < 0.46, respectively at the treatment of 50 and 5 mg/L (mean measured concentration 59.1 and 6.2 mg/L). Therefore, the bioconcentration factor (BCF) of the test substance to zebra fish was < 100. In conclusion, the test substance had no obvious bioconcentration effects on zebra fish under the present conditions of the test.
Validity criteria fulfilled:
yes
Conclusions:
The bioconcentration factor (BCF) of the test substance Blue MGi 1037-Na to zebra fish was <100.
Executive summary:

The bioconcentration effect of the test substance Blue MGi 1037-Na to zebra fish (Brachydanio rerio) was determined in a 28-day semi-static test with a test medium renewal every two days. An exposure test at concentrations of 50 mg/L and 5 mg/L was performed in accordance with the result of the fish acute toxicity test to check out the bioconcentration effect of test substance on the test organisms. Thus, the treatments at concentrations of 50 mg/L and 5 mg/L and the controls were tested. Samples from both test solutions and test organisms were taken daily from the 26th day to the last day during the exposure test period. The samples from test organisms were treated by extracting their lipid component that was collected from the test fish, and the extracted solutions of the test substance were obtained. The concentrations of the test substance in exposure solutions and extracted solutions were measured.

The analytically measured test substance concentrations in the exposure test medium were 59.0 mg/L and 6.1 mg/L, 59.0 mg/L and 6.2 mg/L, 59.2 mg/L and 6.2 mg/L, respectively from the first day to the third day during the sampling period. All of the analytically measured test substance concentrations in the extracted solution were <0.05 mg/L from the first day to the third day of sampling. In the controls and the treatments at the treatment of 50mg/L and 5mg/L (mean measured concentration 59.1 mg/L and 6.2mg/L) no fish death was determined during the limit test period of 28 days. Based on the measured concentrations in the exposure test medium and the test organism, the bioconcentration factor (BCF) of the test substance to zebra fish was calculated as <0.05 and <0.46, respectively at the treatment of 50 mg/L and 5 mg/L (mean measured concentration 59.1mg/L and 6.2mg/L). Therefore, the bioconcentration factor (BCF) of the test substance Blue MGi 1037-Na to zebra fish was <100. In conclusion, the test substance Blue MGi 1037-Na had no obvious bioconcentration effects on zebra fish under the present conditions of the test.

 

Description of key information

The bioconcentration factor (BCF) of the test substance Blue MGi 1037-Na to zebra fish was determined to be < 100.

Key value for chemical safety assessment

Additional information

The bioconcentration effect of the test substance Blue MGi 1037-Na to zebra fish (Brachydanio rerio) was determined in a 28-day semi-static test with a test medium renewal every two days. An exposure test at concentrations of 50 and 5 mg/L was performed in accordance with the result of the fish acute toxicity test to check out the bioconcentration effect of test substance on the test organisms. Thus, the treatments at concentrations of 50 and 5 mg/L and the controls were tested.

 

Samples from both test solutions and test organisms were taken daily from the 26th day to the last day during the exposure test period. The samples from test organisms were treated by extracting their lipid component that was collected from the test fish, and the extracted solutions of the test substance were obtained. The concentrations of the test substance in exposure solutions and extracted solutions were measured.

 

The analytically measured test substance concentrations in the exposure test medium were 59.0 and 6.1 mg/L, 59.0 and 6.2 mg/L, 59.2 and 6.2 mg/L, respectively from the first day to the third day during the sampling period. All of the analytically measured test substance concentrations in the extracted solution were < 0.05 mg/L from the first day to the third day of sampling.

In the controls and the treatments at the treatment of 50 and 5 mg/L (mean measured concentration 59.1 and 6.2 mg/L) no fish death was determined during the limit test period of 28 days. Based on the measured concentrations in the exposure test medium and the test organism, the bioconcentration factor (BCF) of the test substance to zebra fish was calculated as < 0.05 and < 0.46, respectively at the treatment of 50 and 5 mg/L (mean measured concentration 59.1 and 6.2 mg/L). Therefore, the bioconcentration factor (BCF) of the test substance Blue MGi 1037-Na to zebra fish was determined to be <100.

In conclusion, the test substance Blue MGi 1037-Na had no obvious bioconcentration effects on zebra fish under the present conditions of the test. Based on these results and the bioconcentration toxicity grading criteria in the Guidelines for the Hazard Evaluation of New Chemical Substances (HJ/T154-2004), the hazardous level of the test substance is medium.