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EC number: 943-893-0 | 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
Endpoint summary
Administrative data
Description of key information
Skin irriation (OECD 439, GLP): negative (RA CAS 10023-48-0)
Eye irritation (OECD 437, GLP): negative (RA CAS 10023-48-0)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of three tissues
- Value:
- 90.39
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- Source: CAS 10023-48-0, 7.3.1-1
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- Under the conditions of the RHE test method the test substance did not show skin irritant properties. As explained in the analogue justification, it is considered that the target and the source substances are unlikely to lead to differences in skin irritation potential.
CLP: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean value of 3 corneae
- Value:
- 1.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- Source: CAS 10023-48-0, 7.3.2-1
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- Under the conditions of the BCOP assay, the test substance did not show irritant properties towards eyes. As explained in the analogue justification, it is considered that the target and the source substances are unlikely to lead to differences in eye irritation potential.
CLP: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for read-across
There are no reliable data available regarding acute toxicity for Reaction mass of 3-[(4-Amino-2-methyl-5-pyrimidinyl)methyl]-4-methyl-5-{ 2-[hydroxy(phosphonooxy)-phosphinyl]oxyethyl]-thiazoliumchlorid and 3-[( 4-Amino-2-methyl-5-pyrimidinyl)methyl]-4-methyl-5-(2-phosphonooxyethyl)- thiazoliumchlorid-Dihydrat (EC 943-893-0). Read-across from an appropriate substance 3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-4-methyl-5-[2-(phosphonooxy)ethyl]-thiazolium (CAS 10023-48-0) is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. in order to fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VII, 8.3. Common functional groups, structural similarities and comparable toxicological properties (according to the joint consideration in Annex VI to CLP) of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).
Skin irritation
CAS 10023-48-0
The skin irritancy potential of 3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-4-methyl-5-[2-(phosphonooxy)ethyl]-thiazolium was determined in an in vitro skin irritation study using a human skin model according to OECD TG 439 and GLP (reference 7.3.1-1). The negative control OD (2.450, 2.313 and 2.318) was in the acceptance criteria range of ≥ 0.8 and ≤ 3.0 for all three tissues. Exposure to the positive control dodecyl sulfate sodium salt induced a decrease in the relative absorbance as compared to the negative control to 1.13%. Thus, negative and positive controls met the acceptance criteria and can be considered as valid. The mean tissue viability after treatment with the test substance was determined to be 90.39% for all three tissues, thus indicating a clear negative result and the test substance did not show any irritating properties towards human-derived epidermal keratinocytes.
Under the specific circumstances it is possible to conclude that the test substance is not expected to cause skin irritating properties and does not require classification.
Eye irritation
CAS 10023-48-0
To exclude corrosive properties towards the eyes, a bovine corneal opacity and permeability (BCOP) test according to OECD Guideline 437 and in compliance with GLP was conducted (reference 7.3.2-1). After treatment with the negative control (0.9% sodium chloride solution) the calculated IVIS was 1.0 and, therefore within three standard deviations of the current historical mean of the negative control (IVIS: -1.5 to 3.5). After treatment with the positive control (20% imidazole) the calculated IVIS was 107.7 and therefore falls within two standard deviations of the current historical mean of the positive control (IVIS 78.2 to 135.3). Thus, negative and positive controls met the acceptance criteria and can be considered as valid. Application of the test substance to bovine corneae resulted in a calculated mean IVIS of 1.4.
Under the specific circumstances, it is possible to conclude that the test substance is not expected to cause eye irritating properties and does not require classification.
Overall conclusion
3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-4-methyl-5-[2-(phosphonooxy)ethyl]-thiazolium (CAS 10023-48-0) did not exhibit a skin or eye irritation potential. Therefore based on the analogue approach, Reaction mass of 3-[(4-Amino-2-methyl-5-pyrimidinyl)methyl]-4-methyl-5-{2-[hydroxy(phosphonooxy)-phosphinyl]oxyethyl]-thiazoliumchlorid and 3-[(4-Amino-2-methyl-5-pyrimidinyl)methyl]-4-methyl-5-(2-phosphonooxyethyl)- thiazoliumchlorid-Dihydrat (EC 943-893-0) is not considered to exhibit hazardous properties to the skin and towards the eyes.
Justification for classification or non-classification
According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Reaction mass of 3-[(4-Amino-2-methyl-5-pyrimidinyl)methyl]-4-methyl-5-{2-[hydroxy(phosphonooxy)-phosphinyl]oxyethyl]-thiazoliumchlorid and 3-[(4-Amino-2-methyl-5-pyrimidinyl)methyl]-4-methyl-5-(2-phosphonooxyethyl)- thiazoliumchlorid-Dihydrat (EC 943-893-0), data will be generated from information on reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.
The available data on skin and eye irritation from the source substance 3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-4-methyl-5-[2-(phosphonooxy)ethyl]-thiazolium do not meet the criteria for classification according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.
Therefore, applying the RA-A approach, the target substance Reaction mass of 3-[(4-Amino-2-methyl-5-pyrimidinyl)methyl]-4-methyl-5-{ 2-[hydroxy(phosphonooxy)-phosphinyl]oxyethyl]-thiazoliumchlorid and 3-[( 4-Amino-2-methyl-5-pyrimidinyl)methyl]-4-methyl-5-(2-phosphonooxyethyl)- thiazoliumchlorid-Dihydrat is also considered no to meet the classification criteria for skin and eye irritation.
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.
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