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Reaction mass of Cuprate(4-), [μ-[[3,3'-methylenebis[6-[[5-[(2,4-disulfophenyl)azo]-2,4-dihydroxyphenyl]azo]benzoato]](8-)]]di-, sodium and copper (2+) pentasodium 2-[2-{2-amino-5-[2-(2,4-disulfophenyl)diazen-1-yl]-4-hydroxyphenyl}diazen-1-yl]-5-({3-carboxy-4-[2-{5-[2-(2,4-disulfophenyl)diazen-1-yl]-4-hydroxy-2-oxidophenyl}diazen-1-yl]phenyl}methyl)benzoate and sodium chloride
EC number: 948-009-7 | CAS number: -
- 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:
- June 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP Compliance Certificate of the Testing Laboratory attached in Annex 1 page 24 of the report
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Reaction mass of Cuprate(4-), [μ-[[3,3'-methylenebis[6-[[5-[(2,4-disulfophenyl)azo]-2,4-dihydroxyphenyl]azo]benzoato]](8-)]]di-, sodium and copper(2+) disodium 5-[(3-carboxyphenyl)methyl]-2-[2-{4-hydroxy-2-oxido-5-[2-(4-sulfophenyl)diazen-1-yl]phenyl}diazen-1-yl]benzoate” and sodium chloryde
- EC Number:
- 948-009-7
- Molecular formula:
- Not applicable for a multi-constituent substance
- IUPAC Name:
- Reaction mass of Cuprate(4-), [μ-[[3,3'-methylenebis[6-[[5-[(2,4-disulfophenyl)azo]-2,4-dihydroxyphenyl]azo]benzoato]](8-)]]di-, sodium and copper(2+) disodium 5-[(3-carboxyphenyl)methyl]-2-[2-{4-hydroxy-2-oxido-5-[2-(4-sulfophenyl)diazen-1-yl]phenyl}diazen-1-yl]benzoate” and sodium chloryde
- Test material form:
- solid: particulate/powder
- Details on test material:
- Acid brown 161 batch no. ID151860 CAS no. 85338-16-5
Composition of the muti-constituent substance is included in the report as an extract of the analytical report.
Constituent 1
- Specific details on test material used for the study:
- Acid brown 161 batch no. ID151860, CAS no. 85338-16-5, Einecs Mo. 286-689-0.
Appearance: Dark brown powder. Purity and composition described in the attached "Extract of the analytical report".
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- 29 females of 9-11 weeks, female animals were non-pregnant and nulliparous were used. The health condition of animals was examined by a veterinarian before initiation of the study. The animals were acclimatated in identical conditiona as during the experiment for 5 days prior to start the treatment. The acclimatation was according to standard operation procedures.
The animals were housed in IVC polycarbonate cages (5 animals per cage) suspended in stainless steel racks, in a room equipped with central air-conditioning. The room temperature was wihing the range of 22+-3ºC, relative humidity was within the range 50-60%.
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 1000 mg/mL
- No. of animals per dose:
- 5 animals per dose
- Details on study design:
- Dose preparation: 1000 mg was mixed with the vehicle up to a volume of 1 mL (1000 mg/mL).
This was the highest achievable concentration (100% w/v). The lower concentrations were prepared by mixing of 500 mg and 250 mg with vehicle up to 1 mL –giving 50, 25% w/v concentration. The dose preparation data are listed in the raw data. The preparations were made freshly before each dosing occasion.
Dose Administration
25 µl of the test item was applied to the dorsum of each ear. The α−Hexylcinnamaldehyde (25%) as positive control and vehicle as a negative control were administrated in the same volume. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Individual body weights - Positive control
Mouse no. Initial body weight Terminal body weight
1 18.58 19.29
2 17.26 17.86
3 18.47 19.24
4 17.95 18.40
5 18.93 19.43
Mean 18.24 18.84*
S.D. 0.649 0.683
* p < 0.005
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- ca. 0.84
- Test group / Remarks:
- Acid Brown 161 25%
- Key result
- Parameter:
- SI
- Value:
- ca. 1.29
- Test group / Remarks:
- Acid Brown 161 50%
- Key result
- Parameter:
- SI
- Value:
- ca. 0.75
- Test group / Remarks:
- Acid Brown 161 100%
- Cellular proliferation data / Observations:
- In comparison with the control group, an increase of the pooled lymph node weights was not observed. The pooled lymph node weights of treated groups were 0.0326g for 25% concentration, 0.0357g for 50% concentration and 0.0249g for 100% concentration of test item. The lymph node weight of control group and positive control group were 0.0387g and 0.0643g, respectively. The DPM values for the three treated groups were 1667 (25%), 2557 (50%) and 1483 (100%), respectively. The SI values for the three treated groups were 0.84 (25%), 1.29 (50%) and 0.75 (100%), respectively.
The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. was not
greater than the threshold value of 3.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The skin sensitizing potential of Acid Brown 161 was assessed using the murine local lymph node assay.
Based on the results of this study, Acid Brown 161 is not considered a skin sensitizer under the condition of this LLNA study. - Executive summary:
The skin sensitization potential of Acid Brown 161 was evaluated by LLNA method, which basic underlying principle is that sensitizers induce a primary proliferation of lymphocytes in the auricular lymph nodes draining the site of chemical application.
In the present study, the test item was applied to the dorsum of each ear of five female mice (CBA/Ca) per group over three consecutive days, at three concentrations. All animals survived throughout the test period without showing any clinical signs of toxicity. Calculated SI values in treated groups remained under the value of 3, which is the threshold to consider the substance as a sensitizer.
Therefore, it was not possible to calculate an EC3 value.
These results demonstrate that the test item Acid Brown 161 was not a skin sensitizer under the test conditions of this study.
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