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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Referenceopen allclose all

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
Test Concentration:
A water soluble fraction of the test item, prepared as a filtrate of a suspension containing 100 mg /L of the test item, and a control.

Control:
In the control, test water was used without addition of the test item.

Dosage of Test Item:
The test item is not easily soluble in test water. To avoid physical effects of undissolved test item on the Daphnia, no concentration above the solubility limit of the test item in test water was tested. Therefore, a nominal loading rate of 100 mg test item/L was prepared by suspending 40.9 mg of test item in 409 mL test water. This suspension was stirred for 24 hours in the dark to dissolve as much test item as possible. Then, the undissolved test item was separated by filtration (0.45 µm cellulose nitrate filter) and the resulting water soluble fraction was used as test medium. The test medium was prepared just before introduction of the Daphnia (= start of the test).
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
Species:
Daphnia magna (Straus), clone 5

Age at Test Start:
From 5.75 to 22 hours old

Origin:
The Daphnia introduced in the test were taken from ibacon's in house laboratory culture.

Breeding Conditions:
The Daphnia were bred in the laboratories of ibacon under similar temperature and light conditions as used in the test. The cultivation of the parental Daphnia was performed in Elendt M4 medium. The test organisms were not first brood progeny. The Daphnia in the stock culture were fed at least on all working days with green algae (Desmodesmus subspicatus) freshly grown in the laboratories of ibacon.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Test temperature:
20 to 21°C
pH:
7.9
Dissolved oxygen:
6.8 to 8.6 mg/L
Nominal and measured concentrations:
Nominal test concentration: 100 mg/l. Measured concentration below LOQ. A control was tested in parallel.
Details on test conditions:
TEST WATER
- Dilution water chemistry: Elendt "M4" according to the test guideline OECD 202
- Properties:
Water Hardness: 1.068 mmol/L as carbon hardness
Alkalinity: 0.348 mmol/L
Conductivity: 691 µS/cm


TEST PROCEDURE
- Test vesselss: flat bottom glassbeakers
- Test volume: 60 ml
- Number of replicates: 1
- Individuals/replicate: 20

FURTHER TEST CONDITIONS
- Light conditions: 16 : 8 hours day-night regime, light intensity 230 to 340 lux
- Observation time: 24, 48 h
Reference substance (positive control):
yes
Remarks:
potassium dichromate
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Validity criteria fulfilled:
yes
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
non-GLP study, no analytical monitoring
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
The test follows the EU Directive 79/831/EEC, Annex V, part C, which is comparable to the OECD guideline 202.
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Heliogen Blau 6920,
Purity ca. 98 %
Analytical monitoring:
no
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:
The substance was prepared with addition of Tween 80 and dilution water. The stock solution contains 500 mg/l of the test substance and 100 mg/l of the dispersant. The stock solution was stirred 10 minutes. Following this, serial dilutions of this test medium were prepared in order to obtain the desired test concentrations. Additionally a culture medium and solvent control was tested in parallel.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Strain: Daphnia magna Straus
- Source: originally obtained from the Institute National de Recherche Chimique Appliquee, France and cultured in the laboratories of BASF since 1978.
- Age of test organisms: 2 - 24 hours
- Feed: Whilst changing water Brewer's yeast was given, also 1 x daily grown Green algae culture
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
2.70 ± 0.5 mmol/l
Test temperature:
20 ± 1°C
pH:
7.7 - 8.8
Dissolved oxygen:
> 2 mg/l
Conductivity:
550 - 650 microS/cm
Nominal and measured concentrations:
Nominal test concentrations: 0, 62.5, 125, 250, 500 mg/l. A control was tested in parallel.
Details on test conditions:
TEST SYSTEM
- Test vessel: flat bottom glass tubes
- Material, size, headspace, fill volume: glass
- Volume of solution: 10 mL
- No. of organisms per vessel: 4
- No. of vessels per concentration (replicates): 5
- No. of vessels per control (replicates): 5
- No. of vessels per vehicle control (replicates): 5


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to the test guideline DIN 38412, L 11
- Ca/mg ratio: 4 :1
- Intervals of water quality measurement: 0, 3, 6, 24, 48 h

OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 16 : 8 hours day-night regime
- Light intensity: diffuse light (5 microeinstein/m*m*s) at 400 - 750 nm wave length

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobility after 0, 24, 48 h

VEHICLE CONTROL PERFORMED: yes

Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility

Immobilization of daphnia after 48 hours, %:

Nominal test concentration [mg/L]

Immobilization [%]

Solvent Control

5

Control

15

62.5

10

125

5

250

0

500

5

 

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to attached justification.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility

Description of key information

With high probability acutely not harmful to aquatic invertebrates

Key value for chemical safety assessment

Additional information

There are no studies available that assess the acute toxicity of the test substance to aquatic invertebrates. However, as the test substance belongs to the substance group of Phthalocyanines whose group members resemble in their chemical structure as well as in their phys-chem properties, a read-across approach was used to cover this endpoint.


The toxicity of Phthalocyanines to Daphnia magna was tested by guideline studies conducted with the analogue substances CAS 59160-79-1, and CAS 147-14-8.


The toxicity of CAS 59160 -79 -1 to the freshwater invertebrate Daphnia magna was assessed in a study following OECD 202 with static test design and analytical monitoring. An EC50 > 100 mg/L was identified in this study after 48 h of exposure [Ibacon 2015].


The toxicity of CAS 147-14-8 to Daphnia magna was tested in a study following EU Directive 79/831/EEC. The animals were exposed to the test substance for 48 hours and an EC50 > 500 mg/l was determined [BASF AG 1989]. However, a solubilizer was used in this test.