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EC number: 215-410-7 | CAS number: 1325-87-7
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 - 26 September 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have the same type of toxicological effects based on common underlying mechanisms (ECHA, 2015b). All substances have the same organic structural group (colorant) with different compositions of the inorganic group (metallic salt). Read-across is in this case based on the hypothesis that source and target substances have similar toxicological properties because they degrade to the similar chemical substances (ECHA, 2015c). This prediction is supported by physicochemical and toxicological data on the substances.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Name Target Substance Source Substance
Chemical name Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]- Bis[[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthyl]methylene]cyclohexa-2,5-dien-1-ylidene]diethylammonium] dicopper(1+)
2,5-cyclohexadien-1-ylidene]-N-ethyl-, molybdatetungstatephosphate hexa(cyano-C)ferrate(4-)
IUPAC name Reaction product of [4-[bis[4-(diethylamino)phenyl]methylidene]naphthalen-1-ylidene]- Unknown
ethylazanium chloride with phosphotungstomolybdic acid
CAS No 1325-87-7 82338-76-9/57485-98-0
EC No 215-410-7 279-935-3
Colourant C.I. Basic Blue 7 (R30200) C.I. Basic Blue 7 (R30200)
Metals Phosphotungstomolybdic acid salt Copper ferrocyanide salt
Molecular weight range ≥ 6600 ≤ 10500 880-1750
Molecular formula (C33H40N3)z.O3.P2O5.(WO3)x.(MoO3)y C33H40N3.1/2C6FeN6.Cu
12 ≤ x+y ≤ 24 (x≥1; y≥1)
z = 6-10
Structural formula
Both substances are UVCB’s and so purity is considered to be 100%
3. ANALOGUE APPROACH JUSTIFICATION
The target substance CAS 1325-87-7is an organometallic multi-constituent substance. The source substance CAS 63022-06-0 has the same colourant (organic constituent) (see table above) as the target substance consisting of a basic [4-[bis[4-(diethylamino)phenyl]methylidene]naphthalen-1-ylidene]-ethylazanium. The inorganic Part B is different between source and target substances, consisting of the elements O, Mo, P and W for the target substance and Cu, Fe and CN for the source substance. These differences are expected to behave very similar. The target and source substances are thus considered suitable for the analogue approach based on structural similarity. - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch no 278PE160900, Source Sponsor
- Expiration date of the lot/batch: 01 July 2022
- Purity test date: not specified
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: Not performed
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
-The test substance was prepared as a suspension in propylene glycol. This vehicle was chosen as it produced the highest concentration that was suitable for dosing. - Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Reputable commercial supplier
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known:
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15 - 23g
- Housing: solId floor propylene cages
- Diet (e.g. ad libitum): Teklad Global Rodent diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
- Indication of any skin lesions: not stated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%)30 to 70%:
- Air changes (per hr): 1 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness
- IN-LIFE DATES: From: To: 11-26 September 2017 - Vehicle:
- propylene glycol
- Concentration:
- 2.5, 5 and 10% w/w
- No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: not applicable
- Irritation:
- Systemic toxicity: None noted
- Ear thickness measurements: pre-dose on Day 1, post-dose on Day 3 and Day 6
- Erythema scores:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:
- Criteria used to consider a positive response:
TREATMENT PREPARATION AND ADMINISTRATION: - Statistics:
- The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (disintegrations per minute/node) and as the ratio of3 HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index).
The test item will be regarded as a sensitizer if at least one concentration of the test item results in a threefold or greater increase in3 HTdR incorporation compared to control values. Any test item failing to produce a threefold or greater increase in3 HTdR incorporation will be classified as a "non-sensitizer". - Key result
- Parameter:
- SI
- Value:
- 1.39
- Test group / Remarks:
- 2.5% w/w
- Key result
- Parameter:
- SI
- Value:
- 1.53
- Test group / Remarks:
- 5% w/w
- Key result
- Parameter:
- SI
- Value:
- 2.5
- Test group / Remarks:
- 10% w/w
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
DETAILS ON STIMULATION INDEX CALCULATION The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (disintegrations per minute/node) and as the ratio of3 HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index).
The test item will be regarded as a sensitizer if at least one concentration of the test item results in a threefold or greater increase in3 HTdR incorporation compared to control values. Any test item failing to produce a threefold or greater increase in3 HTdR incorporation will be classified as a "non-sensitizer".
EC3 CALCULATION
CLINICAL OBSERVATIONS: Purple staining of fur noted.
No signs of systemic toxicity were noted in the test or control animals during the test.
BODY WEIGHTS
Body weight change of the test animals between Day 1 and Day 6 was comparable to that observed in the corresponding control group animals over the same period. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was considered to be a non-sensitiser under the conditions of the test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
PB1 is not classified for skin sensitisation
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