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EC number: 204-980-2 | CAS number: 130-20-1
- 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
Endpoint summary
Administrative data
Description of key information
The test substance does not exhibit a skin sensitizing potential in the Murine Local Lymph Node Assay under the test conditions chosen.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Experimental Toxicology and Ecology, BASF SE, Germany
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sulzfeld, Germany
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 19 - 22.7 g
- Housing: single housing in Makrolon cage, type II
- Diet: Kliba-Labordiaet (Maus / Ratte Haltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- propylene glycol
- Concentration:
- 5, 10, and 25%
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: A solubility experiment was performed according to the recommendations given by OECD 429. The highest test-substance concentration which can be technically used was a 25% test-substance preparation. The test-substance preparations at different concentrations were formulated in propylene glycol.
- Irritation: To determine the highest test-substance concentration that does not induce local signs of skin irritation and/or systemic toxicity, a pre-test (experimental conduct in accordance with GLP but without a GLP status) was performed. Two mice were treated with a 25% test-substance concentration on three consecutive days. In the pre-test clinical signs were recorded after each application as well as on day 5. Signs of local irritation were recorded on day 1, 2 and 5. Furthermore, the ears were punched after sacrifice at the apical area using a biopsy punch (Ø 0.8 cm) and were immediately pooled per animal and weighed using an analytical balance. Additionally the weight of the pooled lymph nodes from both sides was determined for each animal. At the tested concentration of 25% the animals showed some increases in ear weights and lymph node weights. Moreover compound residues on the application area and blue discolored ear skin were noted during the whole observation period. Signs of systemic toxicity were not observed in the pre-test.
Therefore, the following dose levels were selected for the main study: 5%, 10% and 25%.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Murine Local Lymph Node Assay
- Criteria used to consider a positive response: increase in 3H-thymidine incorporation by a factor of >/= 3, cell-count stimulation index (SI >/= 1.5), lymphnode-weight stimulation index and ear weight stimulation index together with dose-response.
TREATMENT PREPARATION AND ADMINISTRATION: The test-substance preparation was produced on a weight per weight basis shortly before the application by stirring with a high speed homogenizer (Ultra-Turrax) and/or a magnetic stirrer. The homogeneity of the test-substance preparation during application was provided by stirring with a magnetic stirrer. Propylene glycol was used as the vehicle because good homogeneity of the preparations was achieved. 25 μL per ear were applied on 3 consecutive days (day 0 – day 2) to the same application site. - Positive control substance(s):
- other: A positive control is not included in the study. A separate study with a positive control (Alpha-Hexylcinnamaldehyde, techn. 85%) is carried out in the laboratory twice a year.
- Statistics:
- Mean values and standard deviations of the measured parameters were calculated for the test and control groups from the individual values. The stimulation indices of 3H-thymidine incorporation, cell count, lymph node weight and ear weight measurements were calculated as the ratio of the test group mean values for these parameters divided by those of the vehicle control group. Further statistical analyses were conducted: 3H-thymidine incorporation, cell count, lymph node weight and ear weight (WILCOXON - Test).
- Parameter:
- SI
- Value:
- 1.89
- Test group / Remarks:
- 5%
- Parameter:
- SI
- Value:
- 1.17
- Test group / Remarks:
- 10%
- Parameter:
- SI
- Value:
- 2.53
- Test group / Remarks:
- 25%
- Cellular proliferation data / Observations:
- vehicle: 1.00 5%: 1.89 (statistically significant for the value p ≤ 0.01) 10%: 1.17 25%: 2.53 (statistically significant for the value p ≤ 0.01)
dpm / lymph node pair: vehicle: 347.9 5%: 658.5 10%: 407.5 25%: 879.2 - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance does not exhibit a skin sensitizing potential in the Murine Local Lymph Node Assay under the test conditions chosen.
- Executive summary:
To test the skin sensitising properties of the test substance, a local lymphnode assay (LLNA) in the mouse was carries out at concentrations of 5%, 10%, and 25% test substance in propylene glycol.
The test substance did not induce biologically relevant increases in the 3H-thymidine incorporation (no increase above the cut off Stimulation Index of 3) into the cells from the auricular lymph nodes or in lymph node cell counts (no increase to 1.5 fold or above of control value = stimulation index (SI) ≥ 1.5). However, statistically significant increases in the 3H-thymidine incorporation were noted in test groups 2 and 4 as well as in lymph node cell counts in test group 4. Additionally, the lymph node weights were statistically significant increased at all concentrations. All test-substance preparations caused statistically significant increases in ear weights as indication of some ear skin irritation. Thus, it is concluded that the test substance does not exhibit a skin sensitizing potential in the Murine Local Lymph Node Assay under the test conditions chosen.
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- 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
Both compounds have the same basic structure “6,15-dihydrodinaphtho[2,3-a:2',3'-h]phenazine-5,9,14,18-tetrone”
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source: Vat Blue 4 – 6,15-dihydrodinaphtho[2,3-a:2',3'-h]phenazine-5,9,14,18-tetrone
Target: Vat Blue 6 – 7,16-dichloro-6,15-dihydrodinaphtho[2,3-a:2',3'-h]phenazine-5,9,14,18-tetrone
3. ANALOGUE APPROACH JUSTIFICATION
The only difference between the source and the target substance is the substitution of two chlorine at the 7, 16-position of the basic structure “6,15-dihydrodinaphtho[2,3-a:2',3'-h]phenazine-5,9,14,18-tetrone”. This substitution does not have any effect on the investigated endpoints.
4. DATA MATRIX
See attachment - Reason / purpose for cross-reference:
- read-across source
- Parameter:
- SI
- Value:
- 1.89
- Test group / Remarks:
- 5%
- Parameter:
- SI
- Value:
- 1.17
- Test group / Remarks:
- 10%
- Parameter:
- SI
- Value:
- 2.53
- Test group / Remarks:
- 25%
- Cellular proliferation data / Observations:
- vehicle: 1.00 5%: 1.89 (statistically significant for the value p ≤ 0.01) 10%: 1.17 25%: 2.53 (statistically significant for the value p ≤ 0.01)
dpm / lymph node pair: vehicle: 347.9 5%: 658.5 10%: 407.5 25%: 879.2 - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance does not exhibit a skin sensitizing potential in the Murine Local Lymph Node Assay
- Executive summary:
When applied as 25%, 10% and 5% preparation in propylene glycol the test substance did not induce biologically relevant increases in the 3H-thymidine incorporation (no increase above the cut off Stimulation Index of 3) into the cells from the auricular lymph nodes or in lymph node cell counts (no increase to 1.5 fold or above of control value = stimulation index (SI) ≥ 1.5). However, statistically significant increases in the 3H-thymidine incorporation were noted in test groups 2 and 4 as well as in lymph node cell counts in test group 4. Additionally, the lymph node weights were statistically significant increased at all concentrations. All test-substance preparations caused statistically significant increases in ear weights as indication of some ear skin irritation. Thus, it is concluded that the test substance does not exhibit a skin sensitizing potential in the Murine Local Lymph Node Assay under the test conditions chosen.
Referenceopen allclose all
Cell Count Stimulation Index
Mean [Counts / lymph node pair] | Stimulation Index | |
vehicle | 8,385,600 | 1.00 |
5% | 8,708,400 | 1.04 |
10% | 8,272,800 | 0.99 |
25% | 11,271,600 | 1.34# |
Ln-Weight Stimulation Index
Mean [mg] | Stimulation Index | |
vehicle | 4.9 | 1.00 |
5% | 5.4 | 1.09# |
10% | 5.9 | 1.21## |
25% | 7.0 | 1.42## |
Ear-Weight Stimualtion Index
Mean [mg] | Stimulation Index | |
vehicle | 28.5 | 1.00 |
5% | 31.9 | 1.12## |
10% | 31.8 | 1.12# |
25% | 34.0 | 1.19## |
# = statistically significant for the value p ≤ 0.05
## = statistically significant for the value p ≤ 0.01
A slight reduction in the mean body weight was observed in test group 3. No signs of systemic toxicity were noticed in all animals during general observation. Compound residues on the application area were noted in all animals of test groups 3 and 4. Blue stained ear skin was observed at all test substance concentrations during the whole observation period.
Cell Count Stimulation Index
Mean [Counts / lymph node pair] | Stimulation Index | |
vehicle | 8,385,600 | 1.00 |
5% | 8,708,400 | 1.04 |
10% | 8,272,800 | 0.99 |
25% | 11,271,600 | 1.34# |
Ln-Weight Stimulation Index
Mean [mg] | Stimulation Index | |
vehicle | 4.9 | 1.00 |
5% | 5.4 | 1.09# |
10% | 5.9 | 1.21## |
25% | 7.0 | 1.42## |
Ear-Weight Stimualtion Index
Mean [mg] | Stimulation Index | |
vehicle | 28.5 | 1.00 |
5% | 31.9 | 1.12## |
10% | 31.8 | 1.12# |
25% | 34.0 | 1.19## |
# = statistically significant for the value p ≤ 0.05
## = statistically significant for the value p ≤ 0.01
A slight reduction in the mean body weight was observed in test group 3. No signs of systemic toxicity were noticed in all animals during general observation. Compound residues on the application area were noted in all animals of test groups 3 and 4. Blue stained ear skin was observed at all test substance concentrations during the whole observation period.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
To test the skin sensitising properties of the test substance, a local lymphnode assay (LLNA) in the mouse was carried out at concentrations of 5%, 10%, and 25% test substance in propylene glycol.
The test substance did not induce biologically relevant increases in the3H-thymidine incorporation (no increase above the cut off Stimulation Index of 3) into the cells from the auricular lymph nodes or in lymph node cell counts (no increase to 1.5 fold or above of control value = stimulation index (SI) ≥ 1.5). However, statistically significant increases in the3H-thymidine incorporation were noted in test groups 2 and 4 as well as in lymph node cell counts in test group 4. Additionally, the lymph node weights were statistically significant increased at all concentrations. All test-substance preparations caused statistically significant increases in ear weights as indication of some ear skin irritation. Thus, it is concluded that the test substance does not exhibit a skin sensitizing potential in the Murine Local Lymph Node Assay under the test conditions chosen.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
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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