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EC number: 280-734-8 | CAS number: 83763-48-8
- 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
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- Nanomaterial pour density
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- Endpoint summary
- Stability
- Biodegradation
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- 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

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From March 10, 1999 to April 20, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- The study was conducted in general compliance with the methodology published in Methods in Immunotoxicology, Vol. 2, pages 279-290, 1975
- Deviations:
- yes
- Remarks:
- A single cell suspension was prepared for each sub-group and not for each group. Allocation to treatment groups was not performed at the completion of the acclimatation period but during this period.
- GLP compliance:
- yes
- Remarks:
- according to OECD and US FDA principles of GLP
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- (3-ammonio-4-methoxyphenyl)(2-hydroxyethyl)ammonium sulphate
- EC Number:
- 280-734-8
- EC Name:
- (3-ammonio-4-methoxyphenyl)(2-hydroxyethyl)ammonium sulphate
- Cas Number:
- 83763-48-8
- Molecular formula:
- C9H14N2O2.H2O4S
- IUPAC Name:
- (3-ammonio-4-methoxyphenyl)(2-hydroxyethyl)ammonium sulphate
- Reference substance name:
- Lehmann Blau
- IUPAC Name:
- Lehmann Blau
- Reference substance name:
- 2-amino-4-hydroxyethylaminoanisole sulfate
- IUPAC Name:
- 2-amino-4-hydroxyethylaminoanisole sulfate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material: Lehmann Blau (1-methoxy-2-amino-4-β-hydroxyethylaminobenzene-dihydrochloride)
- Substance type: Pure active substance
- Physical state: Grey powder
- Storage condition of test material: At room temperature
Constituent 1
Constituent 2
Constituent 3
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Supplier # Wella AG ; Batch # 57 (Sample No.: R97005275)
- Expiration date of the lot/batch: Not specified
- Purity test date: 8 January 1996
- Composition of test material, percentage of components: 97.7% Lehmann-Blau
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: grey powder form, at room temperature
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle: not specified
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: prepared daily in the vehicle
- Final dilution of a dissolved solid, stock liquid or gel: 0.25, 0.50, 1.0 and 2.0 % (w/v)
- Final preparation of a solid: dissolved in vehicle
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CBA/Ca mouse were obtained from Harlan, UK
- Age at study initiation: 8 weeks
- Weight at study initiation: 18 – 23 g on the arrival of animals.
- Housing: Animals were housed in groups of 5 of the same dose group in plastic cages (265 x160 x 140 mm). Bedding comprised of dust-free sawdust made from spruce tree wood was analyzed at least twice a year for chemical and bacterial contaminants.
- Diet: Mouse pelleted complete diet, ad libidum (Diet reference A04-C10). Diet was sterilized by irradiation and analyzed for chemical and bacterial contaminants.
- Water: Filtered (0.2µm) mains drinking water ad libidum (via bottle). Water was analyzed at least once a year for chemical contaminants and at least twice a year for bacterial contaminants.
- Contaminants: No known contaminants were present in bedding, diet or water at levels which might have interfered with achieving the objective of the study.
- Acclimation period: Animals were acclimatized for 10 days between animal arrival and the start of treatment. All animals received a clinical inspection for ill-health on arrival. Allocation to treatment groups was performed during the acclimatization period, using a computer general randomization.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2°C
- Relative humidity: 55±15%
- Air changes: 12 air changes per hour
- Photoperiod: 12 hours light (artificial)/12 hours dark
IN-LIFE DATES: From: March 19, 1999 To: March 24, 1999
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Remarks:
- DMSO
- Concentration:
- 0 (DMSO), 0.25%, 0.50%, 1% and 2% (w/v)
- No. of animals per dose:
- 5 female animals/dose group
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay (LLNA)
- Criteria used to consider a positive response: The criterion for a positive response was that the test substance or positive control elicits a 3-fold or greater increase in isotope incorporation relative to the negative control group (stimulation index of ≥3).
TREATMENT PREPARATION AND ADMINISTRATION:
- Treatment Preparation: The test substance and positive control solution were prepared daily as a solution in the DMSO (vehicle) at concentrations of 0.25, 0.50, 1 and 2% (w/v). The test preparations were used within 4 hours of preparation.
- Administration of the test preparations: On Day 1, 2 and 3, 25 µL of the test substance preparation at concentrations of 0, 0.25, 0.50, 1 and 2% (w/v) or vehicle was applied on the dorsal surface of both ears. A hair dryer was used for about 5 minute to dry mice ears.
The assay of the positive control (P-phenylenediamene, PPD) was performed with 5 animals per sub-group in the study number 762/018. The results were also included in this report in order to compare the effects obtained with the test substance.
OBSERVATIONS
- Morbidity/mortality: All animals were observed at least once daily.
- Clinical signs: Animals were observed daily. During the treatment period, animals were observed before and at least once after dosing to detect any clinical signs or reaction to treatment.
EVALUATION OF CELL PROLIFERATION:
On Day 6, 250 µL of phosphate buffered saline (PBS) containing 20 µCi of [3H] methyl thymidine was injected intravenously. Five hour later, the mice were sacrificed by carbon dioxide inhalation and the draining auricular lymph node excised. A single cell suspension of lymph node cells was prepared for each sub group. Cells were washed twice with PBS and precipitated with ice cold 5% trichloro-acetic acid (TCA). Approximately 18 hours later, the pellets were resuspended in 1 mL of TCA and transferred to 10 mL scintillation cocktail. Incorporation of 3H-methyl thymidine was measured by liquid scintillation technique using a TRI-CARB 2700TR Packard liquid scintillation analyser. - Positive control substance(s):
- other: p-phenylenediamine(PPD)
- Statistics:
- As the lymph nodes were pooled for each group, no statistical analysis was performed (one value per group only).
Results and discussion
- Positive control results:
- - Stimulation indices were 5.47, 12.39, 19.12 and 7.07 at 0.25%, 0.50%, 1% and 2% (w/v), respectively.
- DPM: 20568.5, 46652.5, 71978.4 and 26597.7 at 0.25%, 0.50%, 1% and 2% (w/v), respectively.
- Corrected DPM: 7.27, 16.48, 25.43 and 9.40 at 0.25%, 0.50%, 1% and 2% (w/v), respectively
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: - Stimulation indices were 1.29, 1.03, 1.12 and 1.42 at 0.25%, 0.50%, 1% and 2% (w/v), respectively. These stimulations indices were not greater than 3, hence the response was considered as negative.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: - DPM: 17373.5, 13898.6, 15087.3 and 19073.2 at 0.25%, 0.50%, 1% and 2% (w/v), respectively. - Corrected DPM: 5.61, 4.49, 4.87 and 6.16 at 0.25%, 0.50%, 1% and 2% (w/v), respectively.
- Key result
- Parameter:
- SI
- Value:
- 1.29
- Test group / Remarks:
- Test item 0.25%
- Key result
- Parameter:
- SI
- Value:
- 1.03
- Test group / Remarks:
- Test item 0.50%
- Key result
- Parameter:
- SI
- Value:
- 1.12
- Test group / Remarks:
- Test item at 1%
- Key result
- Parameter:
- SI
- Value:
- 1.42
- Test group / Remarks:
- Test item at 2%
Any other information on results incl. tables
Evaluation of the cell proliferation
Evaluation of the cell proliferation |
||||
Dose |
DPM |
Corrected DPM (x10E-4) |
Stimulation Index |
|
Negative control |
|
13448.2 |
4.34 |
|
Test item |
0.25 |
17373.5 |
5.61 |
1.29 |
0.5 |
13898.6 |
4.49 |
1.03 |
|
1 |
15087.3 |
4.87 |
1.12 |
|
2.0 |
19073.2 |
6.16 |
1.42 |
|
Positive control |
0.25 |
20568.5 |
7.27 |
5.47 |
0.5 |
46652.5 |
16.48 |
12.39 |
|
1 |
71978.4 |
25.43 |
19.12 |
|
2.0 |
26597.7 |
9.40 |
7.07 |
Mortality:No mortality was observed during the course of the study.
Clinical Signs:No treatment-related clinical signs were observed.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Lehmann Blau (1-methoxy-2-amino-4-β-hydroxyethylaminobenzene-dihydrochloride) did not induced skin sensitization in the Local Lymph Node Assay (LLNA) when tested up to 2% (w/v) solution in DMSO. However, the dose level used were too low for substance sensitization and hypersensitivity evaluation.
- Executive summary:
The study was performed to assess the skin sensitization potential of Lehmann Blau (1-methoxy-2-amino-4-β-hydroxyethylaminobenzene-dihydrochloride) by following method comparable to OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay). The study was conducted in general compliance with the methodology published in Methods in Immunotoxicology, Vol. 2, pages 279-290, 1975
25 μl of negative control (DMSO, the vehicle), 0.25, 0.5, 1 and 2% of Lehmann-Blau in DMSO w/v was applied to the surface of the ear of five female CBA/Ca mice per group for three consecutive days. After application, the ears were dried with a hair dryer for five minutes. As the positive control, p-phenylenediamine (PPD) in DMSO at the same dilutions was used in parallel. On day 5, the mice received an intravenous injection of 250 μl phosphate buffered saline containing 25 μCi of [H3] methyl thymidine. Approximately 5 hours later, the mice were killed by CO2 inhalation and the draining auricular lymph nodes removed and weighed. After preparing a single cell suspension for each mouse, cells were precipitated by TCA and the radioactivity determined by means of liquid scintillation counting as disintegrations per minutes (dpm). The mean dpm per treated group was determined and the stimulation index (SI) – the test item compared to the concurrent vehicle control – calculated.
No concentration dependent increase in the mean SI values (1.29, 1.03, 1.12, 1.42) could be detected for the 4 consecutive concentrations of Lehmann-Blau in DMSO. The sensitivity of the test system was shown by the positive control, PPD, for which the SI were 5.47, 12.39, 19.12 and 7.07 respectively for the 4 consecutive concentrations.
There was no indication of skin sensitisation by Lehmann-Blau at up to 2% in DMSO. An EC3 value could not be calculated. Indeed, LLNA indicates that the substance is not allergenic at a concentration of 2% in DMSO.
However, the study was not performed correctly since the induction concentrations used were too low. These doses are not suitable for a robust hazard assessment for classification and labelling.
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