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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
September from the 06th to the 29th, 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Justification for read across is detailed in section 13.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
adopted on 4 April, 1984
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
yes
Analytical monitoring:
no
Details on test solutions:
213.1 mg of test substance was quantitatively added to 200 ml medium providing a stock solution of 1000 mg/l. From this solution 2 x 100 ml was taken and as such tested.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Species: Daphnia magna (Straus, 1820).
- Breeding: synchronously in DSW with a density of 25 daphnia per litre in a climate room.
- Age of the culture: maxium of 4 weeks.
- Renewal of the culture: after 7 days of cultivation half of the volume medium twice a week.
- Validity: frequent inspection of the culture with respect to number of young, appearance of young and parental daphnia and global feeding behaviour.
- Control of sensitivity: in a 24-hour reference test with potassium dichromate.
- Type and amount of food: a suspension of fresh water algae.
- Feeding frequency: once a day.
- Temperature: 20 ± 2 °C
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
24 h
Test temperature:
Range from 19.0 to 19.5 .
pH:
Range from 8.3 to 8.4
Dissolved oxygen:
Range from 8.7 to 9.0 mg/l
Nominal and measured concentrations:
1000 mg/l nominal
Details on test conditions:
TEST SYSTEM
- Test vessel: all-glass; 250 ml
- No. of organisms per vessel: 10
- No. of vessels per concentration: 2 replicates
- Introduction of young daphnia: into the test medium within ca. 10 minutes after preparation of the test media.
- Feeding: no.
- Controls: blank (test medium without test substance or other additives).

TEST MEDIUM / WATER PARAMETERS
- Preparation of dilution water: Dutch standard water (DSW) formulated using Milli-Q water, according to Adema (Adema D.M.M., 1980).

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light per day.
- Room temperature: 19.0 - 20.5 °C

RANGE FINDING
First, a range finding experiment was performed exposing Daphnia magna for 24 hours to the concentrations of 10, 100 and 1000 mg/l. Based on the results, it was decided to perform a limit study exposing Daphnia magna for 24 hours to 1000 mg/l of the test substance.
Reference substance (positive control):
yes
Remarks:
potassium dichromate
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
After 24 hours of exposure no immobilisation was observed at 1000 mg/l.
Results with reference substance (positive control):
The reference substance was tested at the same time as the final test of the test substance, using daphnia from the same culture.
The 24-hour EC50 was 1.71 mg/l (95 % confidence interval 1.54 - 2.03 mg/l, slope 12.9), which is within the expected range: 0.56 - 1.91 mg/l (n=20).

Overall of results

Test vessel No of organisms No of immobile organisms (24 h)
Control 10 0
Control 10 0
Test item 1000 mg/l 10 0
Test item 1000 mg/l 10 0
Potassium dichromate 0 mg/l 10 0
Potassium dichromate 0.32 mg/l 10 0
Potassium dichromate 0.56 mg/l 10 0
Potassium dichromate 1.00 mg/l 10 0
Potassium dichromate 1.80 mg/l 10 6
Potassium dichromate 3.20 mg/l 10 10

Oxygen and temperature conditions

Concentration [mg/l] Start (t=0) End (t=24)
pH O2 [mg/l] pH O2 [mg/l]
0 8.4 8.7 8.3 9
0 8.4 8.7 8.3 9
1000 8.4 8.8 8.3 9
1000 8.4 8.8 8.3 9
Validity criteria fulfilled:
yes
Remarks:
in the control <10 % of the daphnids immobilised; dissolved oxygen concentration at the end of the test >3 mg/l in control and test vessels
Conclusions:
EC50 (24 h) > 1000 mg/l (nominal)
Executive summary:

A 24-hours acute toxicity limit-test was performed on Daphnia magna, according to OECD 202 (1984). First, a range finding experiment was performed exposing Daphnia magna for 24 hours to the concentrations of 10, 100 and 1000 mg/l. Based on the results, in the main test, organisms were exposed to a solution of 1000 mg/l of the test substance and after 24 hours of exposure mortality was checked. At the end of the test no immobilisation was observed at 1000 mg/l.

After 24 hours of exposure no immobilisation was observed at 1000 mg/l.

Conclusion

EC50 (24 h) > 1000 mg/l (nominal)

Description of key information

Not harmful/toxic for short-term exposure to invertebrates

Key value for chemical safety assessment

Additional information

There is no information about the short-term toxicity potential to invertebrates of Optical Brightener 380, therefore, the available data on the structural analogous Similar Substance 01 have been taken into consideration. The read across approach can be considered reliable and appropriate to investigate the property (details for the approach are included into the IUCLID section 13).

A 24-hours acute toxicity limit-test was performed with Similar Substance 01 on Daphnia magna, according to OECD 202 (1984). Organisms were exposed to a solution of 1000 mg/l of the test substance and after 24 hours of exposure mortality was checked. At the end of the test no immobilisation was observed at 1000 mg/l.

The followed guideline has been modified subsequently the performance of the experiment: the exposure time was raised from 24 to 48 hours and a limit-test at a concentration of 100 mg/l was introduced. Despite the reduction of the exposure time, the test substance concentration was ten fold greater than the currently required value for the limit-test, thus even a more conservative a worst case scenario was evaluated. Exposure time is an essential factor, however, an increase of 24 hours exposure is reasonably not expected to lower the determined LC50 by a whole order of magnitude. For these reasons, the test can be considered as representative for the endpoint.