Reaction products of tetrazotized 5-amino-2-[(E)-2-(4-amino-2-sulfophenyl)ethenyl]benzenesulfonic acid with 6-amino-4-hydroxynaphthalene-2-sulfonic acid and 4-amino-5-hydroxynaphthalene-2,7-disulfonic acid in 2-[bis(2-hydroxyethyl)amino]ethanol

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

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:

guideline study

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

(2008)

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

(2004)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Concentration of 100 mg/L was measured at 0 and 48 hours; and concentration of 0 mg/L at 48 hours only.
- Sample storage conditions before analysis: Routinely, the samples were analysed immediately. Only in exceptional cases, they were stored overnight deep frozen and protected from light.

Vehicle:

no

Details on test solutions:

To produce the only test item concentration, 284.0 mg of the test item were weighed out and were added directly to 1 litre of dilution water and stirred for 24 h on a magnetic stirrer. The pH was measured to be 8.1.
50 mL of the solution were taken and 0.5 mL of dilution water containing 10 daphnids were given to each replicate. For the test item concentration and the control 2 replicates were prepared.

Test organisms (species):

Daphnia magna

Details on test organisms:

- Name: Daphnia magna STRAUS, parthenogenetic females
- Source: Strain of Bundesgesundheitsamt Berlin
- Maintenance and Acclimatisation: A population of parthenogenetic females of synchronized age structure has been maintained for more than 15 years in the test facility under constant temperature conditions (20 +/- 1 °C) at a 16 : 8 hour light-dark photoperiod (light intensity:
< 20 µE x m-2 x s-1). The culture water (so-called 'M4 medium') was partly renewed once a week. The Daphnia were exclusively fed unicellular green algae (Desmodesmus subspicatus) 'ad libitum'. Mortalities of parent Daphnia during the culture period were recorded daily in a semi-quantitative way. The neonates were separated from their parent Daphnia by filtration prior to the acute test.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

16 °dH (= 286 mg/L CaCO3)

Test temperature:

19.4 - 19.9 °C measured at each test vessel at the beginning and thr end of the test

pH:

8.0 - 8.1 measured at each test vessel at the beginning and thr end of the test

Dissolved oxygen:

7.5 - 9.1 mg/L with 90 - 99 % saturation measured at each test vessel at the beginning and thr end of the test

Nominal and measured concentrations:

100 mg/L (nominal) plus control
The results are expressed in terms of nominal concentrations concentrations at 48 h. Effective concentrations correspond to 104.1 % of nominal values at 0 hours and to 99.9 % of nominal values at 48 hours.

Details on test conditions:

Pretreatment of test item and preparation of test item concentrations:
To produce the only test item concentration, 284.0 mg of the test item were weighed out and were added directly to 1 litre of dilution water and stirred for 24 h on a magnetic stirrer.
The pH was measured to be 8.1.
50 mL of the solution were taken and 0.5 mL of dilution water containing 10 daphnids were given to each replicate. For the test item concentration and the control 2 replicates were prepared.
Test system:
- Test vessels: 100 mL glass beakers covered with watch glasses holding 10 neonates in 50 mL of test medium
- Experimental design: 1 test concentration plus 1 control, 10 neonates per vessel, 2 replicates per concentration/control, no feeding during the exposure period, static system
- Method of initiation: neonates were placed in prepared media
- Photoperiod: 16 h light : 8 h dark
- Temperature of incubation unit: 20.2 to 20.3°C
- Aeration: none
- Test item concentration: 100 mg/L (active ingredient)
- Method of administration: direct weighing
- Medium renewal: none
- Duration of exposure: 48 hours
- Criteria of effects: The criterion of adverse effects used in this study was the item-induced alteration of the normal mobility behaviour and the loss of locomotory actions of the neonates, observed at 48 hours.

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

> 100 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

Details on results:

The test medium exhibited a too strong colouration to observe immobility and behaviour of the daphnids at 24 hours. To verify immobilisation and abnormalities at 48 hours daphnids were placed in clear dilution medium.
No toxic effects against Daphnia were observed at a limit test concentration of 100 mg/L of the test item.

Validity criteria fulfilled:

yes

Remarks:

(- The immobilisation and other abnormalities in the controls did not exceed 10 % by the end of the test. - The dissolved oxygen concentration remained above 3 mg/L throughout the exposure period.)

Conclusions:

Daphnia magna was exposed under static conditions for 48 hours to one concentration (100 mg/L) of the test substance. No toxic effect was obseved.

Executive summary:

In order to test acute toxicity to invertebrates of BAYSCRIPT Blaukomponente (MDA salt) Daphnia magna was expoded to the test solution of one nominal concentration of the test substance (100 mg/L) and blank control solution for a period of 48 hours under static conditions. The test medium exhibited a too strong colouration to observe immobility and behaviour of the daphnids at 24 hours. To verify immobilisation and abnormalities at 48 hours daphnids were placed in clear dilution medium and recorded at 24 and 48 hours. The measured concentrations confirmed that deviation from the nominal concentration was less than 20 % (measured concentration were in the range of 99.9 - 104.1 % of nominal concetrations). No toxic effect and abnormal behavior were obsevered. This toxicity study is classified as acceptable and satisfies the guideline requirements for the acute Daphnia study.

Reference 2

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:

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read-across approach should be used for data gap filling of Bayscript Blaukomponente TEA using environmental fate, ecotoxicity and human health toxicity studies of Bayscript Blaukomponente MDA. This approach is justified by structural similarity, i.e. a nearly identical composition, between source and target substance. Since the same method of manufacturing is used for Bayscript Blaukomponente MDA and Bayscript Blaukomponente TEA the composition of these UVCB substances is nearly identical. Bayscript Blaukomponente MDA (source) and Bayscript Blaukomponente TEA (target) exhibit three main organic salt constituents. Structures are mainly differing in the functional groups of the cationic amines MDA and TEA used as counterions.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Bayscript Blaukomponente TEA is a multi-constituent substance, consisting of three main constituents. The cationic counterion of Bayscript Blaukomponente TEA is 2,2'2" nitrilotris[ethanol] (TEA) (CAS no. 105-59-9).
Bayscript Blaukomponente TEA is manufactured in water and is handled and used as an aqueous solution during its lifetime. It is manufactured as a 34 % solution and in the further handling diluted by mixing with other aqueous colourant solutions to give aquatic inks. The solid substance has only been isolated for REACH registration purposes.

Typical concentrations depend on each registrant’s company specific legal entity composition. No impurity relevant for classification and labelling was identified for the composition.

Bayscript Blaukomponente MDA is a multi-constituent substance, consisting of the same three main constituents as Bayscript Blaukomponente TEA. The counterion of Bayscript Blaukomponente MDA is 2,2'-(methylimino)diethanol (MDA) (CAS no. 102-71-6).
Bayscript Blaukomponente MDA is manufactured in water and is handled and used as an aqueous solution during its lifetime. It is manufactured as a 41 % solution and in the further handling diluted by mixing with other aqueous colourant solutions to give aquatic inks. The aqueous solution has been registered under REACH since it was not possible at the time of registration to extract the solid from the aqueous solution without decomposition.

The concentration ranges for each of the three constituents calculated for the water-free source substance are shown in chapter AE A.2. Typical concentrations depend on each registrant’s company specific legal entity composition. No impurity relevant for classification and labelling was identified for the composition.


3. ANALOGUE APPROACH JUSTIFICATION
The UVCB substances Bayscript Blaukomponente MDA (source) and Bayscript Blaukomponente TEA (target) mainly consist each of three identical organic constituents. The structural formula of these constituents is an estimation as acid form due to the analytical results, other isomers with same molecular weight are possible. At the end of the production process the acid form is neutralized in aqueous solution to an ammonium salt with 2,2'-(methylimino)diethanol (for Bayscript Blaukomponente MDA) and 2,2'2" nitrilotris[ethanol] (for Bayscript Blaukomponente TEA), respectively. The constituents of source and target mainly differ in 2,2'-(methylimino)diethanol (MDA) (CAS no. 102-71-6) and 2,2'2" nitrilotris[ethanol] (TEA) (CAS no.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

assessment report

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

> 100 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

Details on results:

The test medium exhibited a too strong colouration to observe immobility and behaviour of the daphnids at 24 hours. To verify immobilisation and abnormalities at 48 hours daphnids were placed in clear dilution medium.
No toxic effects against Daphnia were observed at a limit test concentration of 100 mg/L of the test item.

Validity criteria fulfilled:

yes

Remarks:

(- The immobilisation and other abnormalities in the controls did not exceed 10 % by the end of the test. - The dissolved oxygen concentration remained above 3 mg/L throughout the exposure period.)

Conclusions:

Daphnia magna was exposed under static conditions for 48 hours to one concentration (100 mg/L) of the test substance. No toxic effect was obseved.

Executive summary:

In order to test acute toxicity to invertebrates of BAYSCRIPT Blaukomponente (MDA salt) Daphnia magna was expoded to the test solution of one nominal concentration of the test substance (100 mg/L) and blank control solution for a period of 48 hours under static conditions. The test medium exhibited a too strong colouration to observe immobility and behaviour of the daphnids at 24 hours. To verify immobilisation and abnormalities at 48 hours daphnids were placed in clear dilution medium and recorded at 24 and 48 hours. The measured concentrations confirmed that deviation from the nominal concentration was less than 20 % (measured concentration were in the range of 99.9 - 104.1 % of nominal concetrations). No toxic effect and abnormal behavior were obsevered. This toxicity study is classified as acceptable and satisfies the guideline requirements for the acute Daphnia study.

Description of key information

The following results provide read-across data from Bayscript Blaukomonente MDA. The read-across approach is based on high structural similarity between Bayscript Blaukomponente MDA (source) and Bayscript Blaukomponente TEA (target).

Daphnia magna was exposed under static conditions for 48 hours to one concentration (100 mg/L) of Bayscript Blaukomponente MDA. No toxic effect was obseved.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

> 100 mg/L

Additional information

In order to test acute toxicity of BAYSCRIPT Blaukomponente (MDA salt) to invertebrates Daphnia magna was expoded to the test solution of one nominal concentration of the test substance (100 mg/L) and blank control solution for a period of 48 hours under static conditions. The test medium exhibited a too strong colouration to observe immobility and behaviour of the daphnids at 24 hours. To verify immobilisation and abnormalities at 48 hours daphnids were placed in clear dilution medium and recorded at 24 and 48 hours. The measured concentrations confirmed that deviation from the nominal concentration was less than 20 % (measured concentration were in the range of 99.9 - 104.1 % of nominal concetrations). No toxic effect and abnormal behavior were obsevered. This toxicity study is classified as acceptable and satisfies the guideline requirements for the acute Daphnia study.