Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 284-628-2 | CAS number: 84961-40-0
- 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:
- 2016-08-10 to 2017-08-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2010-07-22
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Amines, C10-14-branched and linear alkyl, bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-) (1:1)
- EC Number:
- 284-628-2
- EC Name:
- Amines, C10-14-branched and linear alkyl, bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-) (1:1)
- Cas Number:
- 84961-40-0
- Molecular formula:
- C32H22CrN10O8.C10-14H21-29NH2
- IUPAC Name:
- Amines, C10-14-branched and linear alkyl, bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-) (1:1)
- Test material form:
- solid
- Details on test material:
- - State of aggregation: solid (powdeQ
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 002-141407
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
OTHER SPECIFICS: Solid / orange
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS B.V.,Inc., 5960 AD Horst, The Netherlands
- Age at study initiation: 8 - 10 weeks (pretest), 8 weeks (main test)
- Weight at study initiation: 18.1 - 21.4 g (pretest), 16.4 - 22.0 g (main test)
- Housing: The animals were single housed in fully air-conditioned rooms.
- Diet: ad libitum, Kliba mouse/rat maintenance diet “GLP”, supplied by Provimi Kliba SA, Kaiseraugst, Basel, Switzerland
- Water: ad libitum, drinking water
- Acclimation period: at least 5 days before the first test-substance application.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- pretest: 10, 25, and 50 %
main test: 2.5, 5, and 10 % - No. of animals per dose:
- pretest: 2
main test: 5 - Details on study design:
- PRE-SCREEN TESTS:
- Irritation: no relevant signs of local irritation were observed at 10 %
- Systemic toxicity: mortality at 25 and 50 %
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3H-thymidine incorporation, cell count and lymph node weight
- Criteria used to consider a positive response:
In order to reveal a possible induction of sensitization, the response in the draining lymph node after epicutaneous application of several concentrations of the test substance to the skin of the dorsal surface of both ears was determined by measuring 3H-thymidine incorporation into the lymph node cells. Additional parameters used to characterize the response are, lymph node cell count and, to a certain extent, lymph node weight. Because irritation by the test substance may also induce lymph node responses, the weights of ear punches taken from the area of test-substance application were determined as an indicator for inflammatory ear swelling due to any irritant action of the test substance.
A test item is regarded as a sensitizer in the LLNA if exposure to at least one concentration of the test item results in an incorporation of 3H thymidine at least 3-fold or greater than that recorded in control mice, as indicated by the stimulation index (SI ≥ 3.0). However, the biological relevance of the obtained stimulation indices is considered in conjunction with the other assessed end points (i.e. cell counts, lymph node weights, ear weights). Hereby, the thresholds used for assessment of cell counts and ear weights are represented by stimulation indices (SI) of 1.5 and 1.25, respectively.
If applicable, the EC (estimated concentration) leading to the respective SI values were calculated by linear or semi-logarithmical regression between the data points directly below and above the SI if possible or using the two nearest points below or above the SI.
TREATMENT PREPARATION AND ADMINISTRATION:
The test-substance preparations were produced on a weight per weight (w/w) basis shortly before application by stirring with a magnetic stirrer. The homogeneity of the test-substance preparation during application was provided by stirring with a magnetic stirrer.
Conduct of the study:
The study comprised three treatment groups and a vehicle control group. Each group consisted of 5 mice.
Randomization:
Prior to first application, the animals were distributed to the individual groups, received their animal numbers and were allocated to the respective cages according to the randomization instructions of „Nijenhuis, A. and Wilf, H.S.: Combinatorial Algorithms, Academic Press, New York, San Francisco, London, 1978, pp. 62 – 64“.
Body weight determination: Individual body weights on day 0 prior to the first application and on day 5 prior to the sacrifice of the animals.
Signs and symptoms: Obvious signs of systemic toxicity and/or local inflammation at the application sites were noted for each animal in the raw data.
Mortality: A check for moribund and dead animals was made twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays.
Form of application: Epicutaneous application is simulating dermal contact with the compound which is possible to occur under practical use conditions.
Application volume: 25 µL per ear
Site of application: Dorsal part of both ears
Frequency of application: 3 consecutive applications (day 0 – day 2) to the same application site.
3H-thymidine injection:
On study day five (about 66 to 72 hours after the last application of test substance to the ears) the mice were injected into a tail vein with 20 µCi of 3H-thymidine in 250 µL of sterile saline.
Terminal procedures:
The animals were sacrificed on study day 5 about 5 hours after 3H-thymidine injection by cervical dislocation under Isoflurane anesthesia.
Determination of ear weight: Immediately after the death of each animal a circular piece of tissue (diameter 0.8 cm) was punched out of the apical part of each ear of all animals. The weight of the pooled punches was determined for each animal. These measurements serve for detecting a potential inflammatory ear swelling.
Removal and weight determination of the lymph nodes: Immediately after removal of the ear punches the left and right auricular lymph nodes were dissected. The weight of the pooled lymph nodes from both sides was determined for each animal.
Preparation of cell suspension and determination of cell count: After weight determination, the pooled lymph nodes of each animal were stored in phosphate buffered saline (PBS) in an ice-water bath until further preparation. A single cell suspension was prepared as soon as possible after dissection by carefully passing the lymph nodes through an iron mesh (mesh size 200 µm) into 6 mL of phosphate-buffered physiological saline. For determination of cell counts, an aliquot of each suspension was further diluted with Casy®ton in a ratio 1:500. The cell count was determined using a Casy®-Counter.
Measurement of 3H-thymidine incorporation of the lymph node cells: The remaining cell suspensions were washed twice with PBS and precipitated with 5% trichloro-acetic acid (TCA). Each precipitate was transferred to scintillation fluid and incorporation of 3H-thymidine into the cells was measured in a β-scintillation counter. - Positive control substance(s):
- other: A concurrent positive control (reliability check) with a known sensitizer was not included in this study.
- 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.
3H-thymidine incorporation, cell count, lymph node weight and ear weight were statistically analyzed by WILCOXON - Test.
Results and discussion
In vivo (LLNA)
Results
- Key result
- Parameter:
- SI
- Value:
- < 3
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
there were no biologically relevant or statistically significant increases in lymph node cell counts (no increase to 1.5-fold or above of control value = stimulation index (SI) ≥ 1.5) at all concentrations.
CLINICAL OBSERVATIONS:
No relevant signs of systemic toxicity were noticed in all animals during general observation. Reddish discolored feces were observed in all test-substance treated animals on study day 2.
BODY WEIGHTS
The expected mean body weight gain was generally observed during the study for animals treated with the vehicle control or with the test substance at 2.5 % and 5 %. However, at the 10 % concentration a mean body weight loss was observed.
Any other information on results incl. tables
Table 1: 3H-thymidine incorporation, cell count and lymph node weight: test group mean values, standard deviations and stimulation indices
Test Group |
Treatment |
3H-thymidine incorporation [DPM/Lymph Node Pair] |
|||
Mean |
S.D. |
Stimulation Index1 |
|||
1 |
Vehicle DMF |
966.5 |
587.8 |
1.00 |
|
2 |
2.5 % in DMF |
1231.2 |
559.3 |
1.27 |
N.S. |
3 |
5 % in DMF |
891.1 |
303.3 |
0.92 |
N.S. |
4 |
10 % in DMF |
1186.6 |
157.5 |
1.23 |
N.S. |
Test Group |
Treatment |
Cell Counts [Counts/Lymph Node Pair] |
|||
Mean |
S.D. |
Stimulation Index1 |
|||
1 |
Vehicle DMF |
14180400 |
1504473 |
1.00 |
|
2 |
2.5 % in DMF |
14415600 |
1491616 |
1.02 |
N.S. |
3 |
5 % in DMF |
12084000 |
1048370 |
0.85 |
N.S. |
4 |
10 % in DMF |
11155200 |
1427984 |
0.79 |
N.S. |
Test Group |
Treatment |
Lymph Node Weight [mg/Lymph Node Pair] |
|||
Mean |
S.D. |
Stimulation Index1 |
|||
1 |
Vehicle DMF |
5.7 |
0.6 |
1.00 |
|
2 |
2.5 % in DMF |
5.7 |
0.4 |
0.99 |
N.S. |
3 |
5 % in DMF |
5.3 |
0.3 |
0.93 |
N.S. |
4 |
10 % in DMF |
5.3 |
0.4 |
0.93 |
N.S. |
Table 2: Ear weight: test group mean values, standard deviations and stimulation indices
Test Group |
Treatment |
Ear Weight [mg/animal] |
|||
Mean |
S.D. |
Stimulation Index1 |
|||
1 |
Vehicle DMF |
30.7 |
1.4 |
1.00 |
|
2 |
2.5 % in DMF |
32.5 |
2.7 |
1.06 |
N.S. |
3 |
5 % in DMF |
31.6 |
1.9 |
1.03 |
N.S. |
4 |
10 % in DMF |
31.0 |
1.9 |
1.01 |
N.S. |
1 test group x / test group 1 (vehicle control)
# statistically significant for the value p ≤ 0.05
## statistically significant for the value p ≤ 0.01
N.S. Not Significant
Table 3: 3H-thymidine incorporation, cell count, lymph node weight and ear weight: individual values
Test Group |
Treatment |
Animal No. |
3H-thymidine incorporation [DPM/ Lymph Node Pair] |
Cell Counts/ Lymph Node Pair |
Lymph Node Weight [mg/ Lymph Node Pair] |
Ear Weight [mg/animal] |
1 |
Vehicle DMF |
1 2 3 4 5 |
741.6 510.3 1996.1 827.7 756.7 |
15816000 12228000 15318000 13086000 14454000 |
6.5 5.4 5.8 4.9 5.9 |
30.3 29.1 31.1 30.1 32.9 |
2 |
2.5% in DMF |
21 22 23 24 25 |
1903.5 720.6 622.2 1638.7 1271.0 |
13968000 15222000 12150000 16110000 14628000 |
6.0 5.3 5.3 6.1 5.6 |
36.5 29.8 30.7 31.7 33.6 |
3 |
5% in DMF |
26 27 28 29 30 |
572.9 803.0 1384.1 769.8 925.9 |
10584000 12096000 12900000 11628000 13212000 |
5.2 4.8 5.4 5.4 5.7 |
32.6 34.4 29.7 30.2 31.1 |
4 |
10% in DMF |
31 32 33 34 35 |
1209.9 911.5 1276.2 1297.5 1238.1 |
10020000 10200000 11958000 10302000 13296000 |
5.2 5.4 5.5 4.6 5.8 |
32.9 28.7 30.8 29.5 32.9 |
Table 4: Body weight data
Test Group |
Treatment |
Animal No. |
Body Weight d0 [g] |
Body Weight d5 [g] |
Body Weight Change d5-d0 [g] |
||||||
Individual |
Mean |
S.D. |
Individual |
Mean |
S.D. |
Individual |
Mean |
S.D. |
|||
1 |
VehicleDMF |
1 2 3 4 5 |
17.7 19.9 16.4 16.9 18.8 |
17.9 |
1.4 |
19.7 19.5 17.4 17.8 20.3 |
18.9 |
1.3 |
2.0 -0.4 1.0 0.9 1.5 |
1.0 |
0.9 |
2 |
2.5%inDMF |
21 22 23 24 25 |
18.7 20.3 18.7 18.5 20.4 |
19.3 |
0.9 |
19.3 21.3 19.3 20.2 21.3 |
20.3 |
1.0 |
0.6 1.0 0.6 1.7 0.9 |
1.0 |
0.5 |
3 |
5% in DMF |
26 27 28 29 30 |
19.9 17.2 19.3 19.0 21.5 |
19.4 |
1.6 |
20.9 18.1 19.7 19.9 21.3 |
20.0 |
1.2 |
1.0 0.9 0.4 0.9 -0.2 |
0.6 |
0.5 |
4 |
10% in DMF |
31 32 33 34 35 |
18.8 18.1 22.0 17.4 18.5 |
19.0 |
1.8 |
18.8 17.7 20.6 17.0 18.2 |
18.5 |
1.4 |
0.0 -0.4 -1.4 -0.4 -0.3 |
-0.5 |
0.5 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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.