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EC number: 257-804-1 | CAS number: 52277-71-1
- 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:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- only 1 concentration tested, however far above the solubility in water
- GLP compliance:
- no
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
- EC Number:
- 276-857-1
- EC Name:
- Hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
- Cas Number:
- 72812-34-1
- Molecular formula:
- C32H18CrN6O8.C11H25NO.H
- IUPAC Name:
- hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Rationale: Recognised as the recommended test system
- Source: Harlan Netherlands; B.V. Postbus 6174L; NL - 5960 AD Horst / The Netherlands
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 17,7 -19,6 g
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- main study: 25%
Pre-test 3.13, 6.25, 12.5, and 25 % - No. of animals per dose:
- Number of animals for the pre-test: 2 females
Number of animals for the main study: 8 females
Number of animals per group: 4 females (nulliparous and non-pregnant)
Number of test groups: 1
Number of control (vehicle) groups: 1 - Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: The test item was placed into a volumetric flask on a tared balance and the vehicle (dimethyl sulfoxide) was quantitatively added. Homogeneity of the test item in the vehicle was maintained during treatment with the magnetic stirrer.
The preparations were made freshly before each dosing occasion.
The data showed that the highest test item concentration, which could be technically used, was a 25 % suspension in DMSO. In other vehicles tested a higher concentration could not be suspended.
In a pre-test in two mice, test item concentrations of 3.13, 6.25, 12.5, and 25 % were tested on one ear each. No irritation effects were observed at these concentrations after a single application.
- Irritation: Due to the intense colour of the test item local irritation reactions such as ear redness could not be detected.
- Systemic toxicity: At the 25 % suspension the treated mouse did not show any signs of systemic toxicity.
- Ear thickness measurements: not swelling of the ears was observed
- Erythema scores: not applicable
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:
- Criteria used to consider a positive response:
TREATMENT PREPARATION AND ADMINISTRATION:
The test item in the main study was, therefore, assayed at 25%.
Concentrations were in terms of material as supplied.
group concentration animals/group
control (vehicle) 0 4
high dose 25% 4
Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear lobe (left and right) with test item concentrations of 25% (w/v) in dimethyl sulfoxide. The application volume, 25 microl, was spread over the entire dorsal surface (size, 8 mm) of each ear lobe once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals).
Administration of 3H-Methyl Thymidine
3H-methyl thymidine (3HTdR) was purchased from GE Healthcare (GE Healthcare product code no. TRA 310; specific activity, 2 Ci/mmol; concentration, 1 mCi/ml).
Five days after the first topical application, all mice were administered with 250 microl of 78.8 MCi/ml 3HTdR (corresponds to 19.7 MCi 3HTdR per mouse) by intravenous injection via a tail vein.
Determination of Incorporated 3HTdR
Approximately five hours after treatment with 3HTdR all mice were euthanised by intraperitoneal injection of Na-thiopental (Trapanal, Altana, D-78467 Konstanz).
The draining lymph nodes were rapidly excised and pooled per group (8 nodes per group). Single cell suspensions (in phosphate buffered saline) of pooled lymph node cells were prepared by gentle mechanical disaggregation through stainless steel gauze (200 Mm mesh size). After washing two times with phosphate buffered saline (approx. 10 ml) the lymph node cells were resuspended in 5 % trichloroacetic acid (approx. 3 ml) and incubated at approximately +4 °C for at least 18 hours for precipitation of macromolecules.
The precipitates were then resuspended in 5 % trichloroacetic acid (1 ml) and transferred to plastic scintillation vials with 10 ml of ‘Ultima Gold’ scintillation liquid and thoroughly mixed.
The level of 3HTdR incorporation was then measured on a beta-scintillation counter. Similarly, background 3HTdR levels were also measured in two 1ml-aliquots of 5 % trichloroacetic acid. The beta-scintillation counter expresses 3HTdR incorporation as the number of radioactive disintegrations per minute (DPM). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- SI 4.07 at 10%
In vivo (LLNA)
Results
- Parameter:
- SI
- Value:
- ca. 2.2
- Test group / Remarks:
- 25%
Any other information on results incl. tables
est item Concentration |
Group |
DPM |
|
Calculation |
|
Result |
|
|
|
DPM-BG |
Lymph nodes (LN) |
DPM/LN |
SI |
|
BG I |
23,72 |
|
|
|
|
|
BG II |
19,95 |
|
|
|
|
|
1 |
6360,36 |
6338,5 |
8 |
792,3 |
1 |
25 |
2 |
14125,80 |
14104,0 |
8 |
1763,0 |
2,2 |
Viability / Mortality
No deaths occurred during the study period.
Clinical Signs
The animals did not show any clinical signs during the course of the study. Due to the intense colour of the test item reddening of the ear skin could not be evaluated.
Body Weights
The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance was tested for in vivo skin sensitization followign OECD 429, LLNA. Under the experimental conditions the substance is not considered a skin sensitizer.
- Executive summary:
The substance was tested for in vivo skin sensitization followign OECD 429, LLNA.
In order to study a possible contact allergenic potential of test item, one group each of four female mice was treated daily with the test item at a concentration of 25% (w/v) in dimethyl sulfoxide by topical application to the dorsum of each ear lobe (left and right) for three consecutive days. A control group of four mice was treated with the vehicle (dimethyl sulfoxide) only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and
incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a beta-scintillation counter.
All treated animals survived the scheduled study period and no signs of toxicity were observed.
A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentration resulted in 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value. In this study Stimulation Index of 2.2 was determined with the test item at concentrations of 25% in dimethyl sulfoxide.
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