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EC number: 916-899-6 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- 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.1 (Acute Toxicity for Fish)
- Version / remarks:
- (2008)
- Deviations:
- yes
- Remarks:
- Deviating to SOP 00139 V.1, but according to the demands of the guideline, the test was performed with 7 fish per concentration and control.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- (1992)
- Deviations:
- yes
- Remarks:
- Deviating to SOP 00139 V.1, but according to the demands of the OEDC guideline 203, the test was performed with 7 fish per concentration and control.
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentration: 100 mg/L plus control
- Storage: Only in exceptional cases, they were stored overnight deep frozen and protected from light. - Vehicle:
- no
- Details on test solutions:
- A direct weighing was prepared to produce the only test concentration of 100 mg/L based on the active ingredient (35.25 %). To achieve this 1418.3 mg of the test item were added to 5 litre of dilution water, treated for 60 seconds at 8000 rpm with an ultra turrax and afterwards stirred for 24 h on a magnetic stirrer.
The pH was measured to be pH 8.2.
Finally 7 fish were given to the only test item concentration and the control. - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- - Name : Zebra fish (Danio rerio)
- Source : Aqua KlöGer (Germany)
- Date supplied : 2012-03-22
- Acclimatisation : Stock held since 2012-03-22 and acclimatised to the test conditions since then.
- Temperature : 20 - 24 °C
- Dissolved oxygen : > 5 mg/L
- Feeding : Commercial fish food, daily. Feeding discontinued 24 h prior to test start.
- Mortalities during acclimatisation period : < 5 %
- Medication : none
- Mean standard length (n = 7) : 3.59 cm (S.D. = 0.17 cm) - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 14.2 °dH (= 253 mg/L CaCO3)
- Test temperature:
- 21.6 - 22.5 °C measured at each test vessel at the beginning and the end of the test
- pH:
- 7.8 - 8.2 measured at each test vessel at the beginning and the end of the test
- Dissolved oxygen:
- 8.3 - 8.8 mg O2/L with 96 - 100 % saturation measured at each test vessel at the beginning and the end of the test
- Nominal and measured concentrations:
- 100 mg/L (nominal) puls control
Effective concentrations correspond to 97.4 % of nominal values at 0 hours and to 98.4 % of nominal values at 96 hours. - Details on test conditions:
- An acute daphnia toxicity rang finding test and an algal growth inhibition rang finding test preceded the fish test. They provided information about the concentration which was used in the fish test.
The following nominal concentrations of the active ingredient of the test item were tested in the range finding test. Acute daphnia toxicity test: 0.1, 1.0, 10 and 100 mg/L, Algal growth inhibition test: 0.001, 0.01, 0.1, 1.0, 10, 100 mg/L.
Pre-treatment of test item and preparation of test item concentrations:
A direct weighing was prepared to produce the only test concentration of 100 mg/L based on the active ingredient (35.25 %). To achieve this 1418.3 mg of the test item were added to 5 litre of dilution water, treated for 60 seconds at 8000 rpm with an ultra turrax and afterwards stirred for 24 h on a magnetic stirrer.
The pH was measured to be pH 8.2.
Finally 7 fish were given to the only test item concentration and the control.
- Test vessels : glass aquaria holding 5 L of test media covered by glass plates
- Experimental design : 1 test concentration plus 1 control, 7 fish per test concentration, no feeding during the exposure period, static system
- Method of initiation : fish were placed in prepared media
- Loading : 0.71 g body weight (wet weight) per litre
- Photoperiod : 16 h light: 8 h dark
- Temperature : 21.6 to 22.5 °C
- Aeration : gentle aeration via narrow glass tubes
- Test item concentration : 100 mg/L (active ingredient)
- Method of administration : direct weighing
- Medium renewal : none
- Duration of exposure: 96 hours
- Criteria of effects : The criterion of death used in this study was the absence of response to physical stimulation. In addition to observations on mortality at 2, 24, 48, 72 and 96 hours, type and incidence of sub lethal effects compared with control fish were observed. - Reference substance (positive control):
- no
- Duration:
- 2 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 24 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 48 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 72 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 2 h
- Dose descriptor:
- LC100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 24 h
- Dose descriptor:
- LC100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 48 h
- Dose descriptor:
- LC100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 72 h
- Dose descriptor:
- LC100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 2 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 24 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 72 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Sublethal observations / clinical signs:
No toxic effects against fish were observed at a limit test concentration of 100 mg/L.
The results are expressed in terms of nominal concentrations. Effective concentrations correspond to 97.4 % of nominal values at 0 hours and to 98.4 % of nominal values at 96 hours.
- Validity criteria fulfilled:
- yes
- Remarks:
- (-The mortality in the controls did not exceed 10 % by the end of the test. -The dissolved oxygen concentration remained above 60 % of the air-saturation value throughout the exposure period. -The pH did not vary by more than 1 unit.)
- Conclusions:
- The acute toxicity to fish (danio rerio) was tested in a static test. After 96 hours of exposure no effect against fish were observed at a limit test concentration of 100 mg/L.
- Executive summary:
A study was performed to assess the acute toxicity of BAYSCRIPT Blaukomponente (MDA salt) to Danio rerio under static conditions. The study was conducted in accordance with Council Regulation (EC) No 440/2008, Method C.1 'Acute toxicity for Fish' (2008) which is in most parts equivalent to the OECD Guideline for Testing of Chemicals No. 203 'Fish, Acute Toxicity Test' (1992).
An acute daphnia toxicity rang finding test and an algal growth inhibition rang finding test preceded the fish test. They provided information about the concentration which was used in the fish test.
Because of the anticipated low toxicity of the test item, fish were exposed in the main test to a limit test concentration of nominally 100 mg/L of active ingredient of the substance for a period of 96 hours. As no toxic effects against fish were observed, no statistical analysis was required to determine the LC 50. Additionally any abnormal behaviour or appearance of the fish was reported every 24 hours.
After 96 hours of exposure a LC50 of >100 mg/L (nominal) was determined.
This toxicity study is classified accptable and satisfies the guideline requirements for the acute fish.
- Endpoint:
- short-term toxicity to fish
- 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:
- 2 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 24 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 48 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 72 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 2 h
- Dose descriptor:
- LC100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 24 h
- Dose descriptor:
- LC100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 48 h
- Dose descriptor:
- LC100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 72 h
- Dose descriptor:
- LC100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 2 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 24 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 72 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Sublethal observations / clinical signs:
No toxic effects against fish were observed at a limit test concentration of 100 mg/L.
The results are expressed in terms of nominal concentrations. Effective concentrations correspond to 97.4 % of nominal values at 0 hours and to 98.4 % of nominal values at 96 hours.
- Validity criteria fulfilled:
- yes
- Remarks:
- (-The mortality in the controls did not exceed 10 % by the end of the test. -The dissolved oxygen concentration remained above 60 % of the air-saturation value throughout the exposure period. -The pH did not vary by more than 1 unit.)
- Conclusions:
- The acute toxicity to fish (danio rerio) was tested in a static test. After 96 hours of exposure no effect against fish were observed at a limit test concentration of 100 mg/L.
- Executive summary:
A study was performed to assess the acute toxicity of BAYSCRIPT Blaukomponente (MDA salt) to Danio rerio under static conditions. The study was conducted in accordance with Council Regulation (EC) No 440/2008, Method C.1 'Acute toxicity for Fish' (2008) which is in most parts equivalent to the OECD Guideline for Testing of Chemicals No. 203 'Fish, Acute Toxicity Test' (1992).
An acute daphnia toxicity rang finding test and an algal growth inhibition rang finding test preceded the fish test. They provided information about the concentration which was used in the fish test.
Because of the anticipated low toxicity of the test item, fish were exposed in the main test to a limit test concentration of nominally 100 mg/L of active ingredient of the substance for a period of 96 hours. As no toxic effects against fish were observed, no statistical analysis was required to determine the LC 50. Additionally any abnormal behaviour or appearance of the fish was reported every 24 hours.
After 96 hours of exposure a LC50 of >100 mg/L (nominal) was determined.
This toxicity study is classified accptable and satisfies the guideline requirements for the acute fish.
Referenceopen allclose all
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).
A study was performed to assess the acute toxicity of BAYSCRIPT Blaukomponente (MDA salt) to Danio rerio under static conditions. The study was conducted in accordance with Council Regulation (EC) No 440/2008, Method C.1 'Acute toxicity for Fish' (2008) which is in most parts equivalent to the OECD Guideline for Testing of Chemicals No. 203 'Fish, Acute Toxicity Test' (1992).An acute daphnia toxicity rang finding test and an algal growth inhibition rang finding test preceded the fish test. They provided information about the concentration which was used in the fish test.
Because of the anticipated low toxicity of the test item, fish were exposed in the main test to a limit test concentration of nominally 100 mg/L of active ingredient of the substance for a period of 96 hours. As no toxic effects against fish were observed, no statistical analysis was required to determine the LC 50. Additionally any abnormal behaviour or appearance of the fish was reported every 24 hours.
After 96 hours of exposure a LC50 of >100 mg/L (nominal) was determined.
This toxicity study is classified accptable and satisfies the guideline requirements for the acute fish.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 100 mg/L
Additional information
Key value should read > 100 mg/L
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.