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EC number: 215-385-2 | CAS number: 1324-76-1
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from July 09, 2012 to November 15, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline test with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Pigment blue 61
- IUPAC Name:
- Pigment blue 61
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- colour:dark blue
consistency:solid
form:crystalline powder
Designation Pigment blue 61
Product name Print Alkali Blue 61DT6101
CAS no. #1324-76-1
Receipt no. 51074
Date of receipt: June 28, 2012
Characteristics Powder
Storage conditions In a cool dry place, isolated from incompatible materials. Kept away from heat, sparks, flame and from direct sunlight.
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
- Details on test animals and environmental conditions:
- 4.1 Animals / Animal maintenance
NMRI mice supplied by Charles River Deutschland GmbH were used in this experiment.
Species Mice (non-pregnant, nulliparous, healthy)
Strain / Stock NMRI / Crl:NMRI
Breeder Charles River Laboratories,
Research Models and Services,
Germany GmbH
Sandhofer Weg 7
97633 Sulzfeld, Germany
Selection of species The mouse is a rodent commonly used for such a study.
Sex Female
Number of animals 36 (6 groups of 6 female animals each)
Body weight (on test day 1) 28 - 32 g
Age (on test day 1) 62 days
Identification of animals By cage label; ear tags were not used for identification of animals
Adaptation period At least 5 days
Housing
Before application the animals were housed in groups in MAKROLON cages (type III) with a basal surface of approx. 39 cm x 23 cm and a height of approx. 15 cm at a room temperature of 22°C 3°C (maximum range) and a relative humidity of 55% 15% (maximum range). After application the animals were housed singly in order to prevent their licking off the test item from the ears of the other animals.
Deviations from the maximum range caused for example during cleaning procedures and change of cages are dealt with in SOPs.
The rooms were alternately lit (150 lux at approx. 1.50 m room height) and darkened for periods of 12 hours each. The air in the rooms was changed 12 - 18 times per hour.
Granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany) was used as bedding material for the cages. The cages were changed and cleaned once a week.
Periodic analysis of the bedding material for contaminants based on EPA/USA is conducted at least once a year by LUFA-ITL (see Appendix 2: Limitation for contaminants in the bedding material).
Drinking water
Tap water was offered ad libitum.
This food was offered ad libitum. Food residue was removed.
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 5%, 10% and 25%, w/w) dissolved in dimethyl sulfoxide (DMSO)
- No. of animals per dose:
- 6
- Details on study design:
- Preliminary experiment
A preliminary experiment was carried out in 3 animals to examine the irritating potential and handling/application of the test item in order to select the appropriate concentra-tions. Three concentrations of 5, 10 and 25% of Pigment blue 61 in DMSO were exam-ined. Doses were selected according to OECD guideline from the concentration series 100%, 50%, 25%, 10%, 5%, 2.5%, 1%, 0.5% etc.
Pigment blue 61 was a brown powder. A 25% solution was the maximum applicable concentration of Pigment blue 61 in DMSO.
The experimental schedule of the assay was as follows:
- Day 1:
The weight of each animal was individually identified and recorded. In addition, ear swelling measurements were carried out at the helical edge of both ears using an Oditest micrometer.
Open application of 25 µL of the appropriate dilution of the test item, the vehicle alone or the positive control (as appropriate) were administered to the dorsum of each ear.
- Days 2 and 3:
The application procedure carried out on day 1 was repeated.
- Day 4 (24 hours after the last application the animals were sacrificed under ether anaesthesia by cutting the aorta abdominalis):
Ear swelling measurements (immediately before sacrificing the mice) were carried out at the helical edge of both ears using an Oditest micrometer.
Punch biopsies of 8 mm in diameter of the apical area of both ears were prepared and immediately weighed on an analytical balance.
Lateral pairs of auricular lymph nodes draining the ear tissue were excised, carefully separated from remaining fatty tissue and weighed on an analytical balance immediately following preparation. The lymph nodes were then stored on ice in PBS /0.5% BSA and subjected to the preparation of single cell suspensions by mechanical tissue disaggregation. The cells were counted automatically in a cell counter.
In addition, the acute inflammatory skin reaction is measured by ear weight determination of circular biopsies of the ears and ear thickness measurements on test day 1 and test day 4 to identify skin irritation properties of the test item. It is important to determine if a positive test result is due to the skin irritation potential of the test item or due to its sensitising properties.
Observations
Dated and signed records of all activities relating to the day by day running and maintenance of the study within the animal unit as well as to the group observations and examinations outlined in the Study Plan were recorded in the appropriate documentation. In addition, observations related to individual animals were made throughout the study and were recorded.
The following observations were made during the course of the study:
Clinical signs
Animals were observed once daily for any clinical signs of local systemic irritation at the application site or of systemic toxicity. Observations were recorded for each individual animal. Cageside observations included skin/fur, eyes, mucous mem¬branes, respiratory and circulatory systems, somatomotor activity and behaviour patterns. The onset, intensity and duration of any signs observed were recorded.
In addition, animals were checked regularly throughout the working day from 7:30 a.m. to 4:30 p.m. On Saturdays and Sundays animals were checked regularly from 8:00 a.m. to 12:00 noon with a final check performed at approximately 4:00 p.m., if applicable.
Dated and signed records of appearance, change and disappearance of clinical signs were maintained on clinical history sheets for individual animals.
Body weight
The weight of each mouse was recorded at the time of allocation of animals to groups (test day 1) and at the time of necropsy (test day 4). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Stimulation indices were calculated for the lymph node cell count, lymph node weight, ear weight and ear thickness by dividing the average values per group of the test item treated animals by the vehicle treated ones. Values above 1.4 (lymph node cell count to identify sensitisation) or 1.1 (ear weight to identify irritation) are considered positive (these values were fixed empirically during the inter-laboratory validation of this method (Ehling et al. 2005a and 2005b).
Results and discussion
- Positive control results:
- The positive control group caused the expected increases in lymph node cell count and lymph node weight (statistically significant at p ≤ 0.01). Therefore, the study can be regarded as valid.The vehicle of the positive control (acetone/olive oil (3+1 v/v)) showed neither sensitising nor irritating properties.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- In the main study treatment with Pigment blue 61 at concentrations of 5%, 10% or 25% did not reveal statistical significantly increased values for lymph node cell count. The stimulation indices of the lymph node cell count did not exceed the threshold level of 1.4 (details see table in the field for other information).
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: no data
Any other information on results incl. tables
In a preliminary experiment, concentrations of 5%, 10% and 25%ofPigment blue 61, employing 1 animal per concentration, were examined. No pronounced irritating properties were observed in this preliminary experiment at concentrations of 5%, 10% or 25%, no differences in ear weight and ear thickness were noted.
No signs of local or systemic intolerance were recorded. The animal body weight was not affected by the treatment.
Stimulation indices (SI):
Parameter |
Group 1, negative control |
Group 2, 5% |
Group 3, 10% |
Group 4, 25% |
Group 5, positive control |
Group 6, vehicle of positive control |
Lymph node cell count |
1.000 |
1.072 |
1.306 |
0.905 |
2.234 |
1.204 |
Lymph node weight |
1.000 |
0.950 |
1.050 |
1.083 |
1.460 |
0.983 |
Ear weight |
1.000 |
1.031 |
0.985 |
1.056 |
1.072 |
0.959 |
Difference of ear thickness |
1.000 |
1.077 |
1.032 |
1.044 |
1.177 |
0.929 |
____ significantly different from control at p ≤ 0.01
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the present test conditions, test article at concentrations of 5%, 10% or 25% (w/w) in DMSO did not reveal any sensitising properties in the local lymph node assay and therefore should not be classified according to (EC) No.: 1272/2008.
- Executive summary:
This study was performed to determine the sensitizing potential of test article in the local lymph node assay in mice. The study employed the alternative method of the lymph node weight and lymph node cell count to assess proliferation. Treatment with test article atconcentrations of 5%, 10% or 25% did not reveal statistical significantly increased values for lymph nodecell count. The stimulation indices of the lymph node cell count did not exceed the threshold level of 1.4. Hence, the test item is classified as not sensitizing. No signs of local or systemic intolerance were recorded. The animal body weight was not affected by the treatment. Based on the results of this study, test article at concentrations of 5%, 10% or 25% (w/w) did not reveal any sensitising properties in the local lymph node assay and therefore should not be classified according to (EC) No.: 1272/2008.
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