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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 irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 August - 28 August 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch no 278PE160900 from Client
- Expiration date of the lot/batch: 28 April 2022
- Purity test date: Not stated
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Roomtemperature in the dark
- Stability under test conditions: Stable
- Solubility and stability of the test substance in the solvent/vehicle: Used as supplied
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: N/a
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None
- Preliminary purification step (if any): N/a
- Final dilution of a dissolved solid, stock liquid or gel: N/a
- Final preparation of a solid: Used as supplied
FORM AS APPLIED IN THE TEST (if different from that of starting material) Used as supplied
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: SkinEthic Laboratories
- Source strain:
- other: Reconstructed human epidermis
- Amount/concentration applied:
- Used as supplied = 100% (10 mg)
- Duration of treatment / exposure:
- 15 mins
- Number of replicates:
- 3
- Controls:
- yes
- Details on study design:
- An assessment of the test item’s capability to directly reduce MTT was inconclusive due to the intrinsic color of the test item. Therefore, an additional procedure using water killed tissues was performed. The results of the water killed tissues were subtracted from the mean OD of the test item treated viable tissues to obtain the true amount of MTT reduction that reflects metabolic conversion only.
The solution containing the test item was a blue color, therefore additional color correction tissues were incorporated into the testing procedure. The results of the color correction tissues were subtracted from the mean OD of the test item treated viable tissues to obtain the true amount of MTT reduction that reflects metabolic conversion only.
The results of the third set of control tissues were used to adjust the calculated correction factors derived from the color interference and MTT direct reduction controls in order to prevent a double correction from a colored test item that also reduces MTT. Mean OD570 values and correction factor calculations are given in the report. - Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean of three runs
- Value:
- 44.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test item was classified as irritant. The following classification criteria apply:
EU CLP and UN GHS Hazard statement H315 “Causes Skin Irritation” Category 2 - 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:
- 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-
2,5-cyclohexadien-1-ylidene]-N-ethyl-, molybdatetungstatephosphate dien-1-ylidene]diethylammonium] dicopper(1+) hexa(cyano-C)ferrate(4-)
IUPAC name Reaction product of [4-[bis[4-(diethylamino)phenyl]methylidene]naphthalen-1-ylidene]-
ethylazanium chloride with phosphotungstomolybdic acid Unknown
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. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch no 278PE160900 from Client
- Expiration date of the lot/batch: 28 April 2022
- Purity test date: Not stated
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Roomtemperature in the dark
- Stability under test conditions: Stable
- Solubility and stability of the test substance in the solvent/vehicle: Used as supplied
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: N/a
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None
- Preliminary purification step (if any): N/a
- Final dilution of a dissolved solid, stock liquid or gel: N/a
- Final preparation of a solid: Used as supplied
FORM AS APPLIED IN THE TEST (if different from that of starting material) Used as supplied
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: SkinEthic Laboratories
- Source strain:
- other: Reconstructed human epidermis
- Amount/concentration applied:
- Used as supplied = 100% (10 mg)
- Duration of treatment / exposure:
- 15 mins
- Number of replicates:
- 3
- Controls:
- yes
- Details on study design:
- An assessment of the test item’s capability to directly reduce MTT was inconclusive due to the intrinsic color of the test item. Therefore, an additional procedure using water killed tissues was performed. The results of the water killed tissues were subtracted from the mean OD of the test item treated viable tissues to obtain the true amount of MTT reduction that reflects metabolic conversion only.
The solution containing the test item was a blue color, therefore additional color correction tissues were incorporated into the testing procedure. The results of the color correction tissues were subtracted from the mean OD of the test item treated viable tissues to obtain the true amount of MTT reduction that reflects metabolic conversion only.
The results of the third set of control tissues were used to adjust the calculated correction factors derived from the color interference and MTT direct reduction controls in order to prevent a double correction from a colored test item that also reduces MTT. Mean OD570 values and correction factor calculations are given in the report. - Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean of three runs
- Value:
- 44.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test item was classified as irritant. The following classification criteria apply:
EU CLP and UN GHS Hazard statement H315 “Causes Skin Irritation” Category 2
Referenceopen allclose all
The relative mean tissue viability for the positive control treated tissues was 10.7% relative to the negative control treated tissues and the standard deviation value of the viability was 2.8%. The positive control acceptance criteria were therefore satisfied.
The mean OD570for the negative control treated tissues was 0.847 and the standard deviation value of the viability was 9.8%. The negative control acceptance criteria were therefore satisfied.
The standard deviation calculated from individual tissue viabilities of the three identically test item treated tissues was 11.3%. The test item acceptance criterion was therefore satisfied.
The relative mean tissue viability for the positive control treated tissues was 10.7% relative to the negative control treated tissues and the standard deviation value of the viability was 2.8%. The positive control acceptance criteria were therefore satisfied.
The mean OD570for the negative control treated tissues was 0.847 and the standard deviation value of the viability was 9.8%. The negative control acceptance criteria were therefore satisfied.
The standard deviation calculated from individual tissue viabilities of the three identically test item treated tissues was 11.3%. The test item acceptance criterion was therefore satisfied.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 Jul 1993 - 27 Jul 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0151N/901035
- Storage: room temperature
- Physical Appearance: dark purple powder - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12 – 16 weeks old
- Weight at study initiation: 2.20 – 2.42 kg
- Housing: suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 23
- Humidity (%): 56 - 68
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/ 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL (63mg)
- Observation period (in vivo):
- 1, 24, 48 and 72 hours, 7 and 14 days
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable as no effect seen
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Other effects:
- Blue – coloured staining was noted on two treated eyes during the study. The staining did not affect evaluation of ocular effects.
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- The test item is classed as irritating to the eye
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 Jul 1993 - 2 Aug 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 155N/ 881715
- Expiration date of the lot/batch:
- Physical Appearance: purple powder
- Storage: room temperature - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12 – 16 weeks
- Weight at study initiation: 2.56 – 2.84 kg
- Housing: suspend metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24
- Humidity (%): 56 - 75
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied:0.1mL (83 mg) - Duration of treatment / exposure:
- -
- Observation period (in vivo):
- 72 hours (1, 24, 48 and 72 hours after the treatment)
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Residual test material was noted around the eye of treated animals throughout the study.
Blue – coloured staining was noted in all treated eyes during the study.
Diffuse corneal opacity was noted in all treated eyes at the 24, 48 and 72 hours observations.
Iridial inflammation was noted in all treated eyes one hour after treatment and the 24, 48 and 72 hour observation. No other iridial effects were noted.
Moderate conjunctival irritation was noted in all treated eyes on and 24 hours after treatment with minimal to moderate conjunctival irritation at the 48 and 72 observations. Minimal conjunctival irritation was noted in one of treated eye at the 7-day observation. Petechial haemorrhage of the nictitating membrane was noted in one treated eye at the 24-hour observation.
No ocular effects were noted 7 or 14 days after treatment. - Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- Test item is classed as irrItating to eyes.
Referenceopen allclose all
animal #1 | animal #2 | animal #3 | |||||||||||
24 h | 48 h | 72 h | mean animal #1 | 24 h | 48 h | 72 h | mean animal #2 | 24 h | 48 h | 72 h | mean animal #3 | mean | |
A - Redness | 1 | 0 | 0 | 0.3 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 1.4 |
B - Chemosis | 0 | 0 | 0 | 0 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 |
1.3 |
D - Iris | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0.7 |
E - Degree of Opacity |
0 |
0 |
0 |
0 |
1 |
2 |
2 |
1.7 |
1 |
1 |
1 |
1 |
0.9 |
animal #1 | animal #2 | animal #3 | |||||||||||
24 h | 48 h | 72 h | mean animal #1 | 24 h | 48 h | 72 h | mean animal #2 | 24 h | 48 h | 72 h | mean animal #3 | mean |
|
Conjunctival Redness |
2 |
2 |
2 |
2 |
2 |
2 |
1 |
1.7 |
2 |
2 |
2 |
2 |
1.9 |
Conjunctival Chemosis |
2 |
2 |
2 |
2 |
2 |
1 |
1 |
1.3 |
2 |
2 |
2 |
2 |
1.8 |
Iritis | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
Corneal opacity |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for classification or non-classification
PB1 is classified as irritating to the eye GHS Cat 2 and irritating to the skin GHS Cat 2
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.