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Diss Factsheets
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Reaction mass of sodium amino-bis{[4-(ethenylsubstituted)phenyl]diazenyl}-hydroxynaphthalenesulfonate and polysodium amino-{[4-(ethenylsubstituted)phenyl]diazenyl}-{[4-(ethenylsubstituted)-2-sulfonatophenyl]diazenyl}-hydroxynaphthalenesulfonate and polysodium amino-bis{[4-(ethenylsubstituted)-2-sulfonatophenyl]diazenyl}-hydroxynaphthalenesulfonate
EC number: - | 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
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Guidelines followed
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- None
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- Test system: Mice, CBA/CaOlaHsd
Rationale: Recognised as the recommended test system.
Source: Harlan Laboratories B.V., Postbus 6174, 5960 AD Horst / The Netherlands
Number of animals for pre-test: 5 females (2 for the 1st and 2nd pre-test, each, and 1 for the 3rd pre-test)
Number of animals for the main study: 16 females
Number of animals per group: 4 females (nulliparous and non-pregnant)
Number of test groups: 3
Number of control (vehicle) groups: 1
Age (at beginning of treatment):
1st pre-test: 10 - 11 weeks
2nd pre-test and main study: 9 - 10 weeks
3rd pre-test: 8 - 9 weeks
Identification: The animals were distributed into the test groups at random. All animals belonging to the same experimental group were kept in one cage. In the main experiment, the animals were identified by tail tags. In the pre-experiment, animals were identified by cage number.
Acclimation: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
The animals were kept conventionally. The experiment was conducted under standard laboratory conditions.
Housing: group
Cage Type: Makrolon Type II (pre-test) / III (main study), with wire mesh top
Bedding: granulated soft wood bedding
Feed: 2018C Teklad Global 18% protein rodent diet (certified), ad libitum
Water: tap water, ad libitum
Environment: temperature 22 + 2°C, relative humidity approx. 45-65%, artificial light 6.00 a.m. - 6.00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Remarks:
- Purity: 99%
- Concentration:
- 0, 2, 5, 10 % (w/w)
- No. of animals per dose:
- 4
- Details on study design:
- Not available
- Positive control substance(s):
- other: α hexyl cinnamaldehyde dissolved in acetone/olive oil (4+1, v/v)
- Statistics:
- Not available
Results and discussion
- Positive control results:
- None
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Remarks on result:
- other: Test item concentration / S.I. 0 / 1.00 2 /8.61 5 / 8.47 10 / 8.89
- Key result
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Test item concentration / Measurement DPM / DPM per lymph node 0 / 4680 / 582.9 2 / 40169 / 5019.1 5 / 39539 / 4940.3 10 / 41477 / 5182.6
Any other information on results incl. tables
Viability / Mortality
No deaths occurred during the study period.
Clinical Signs
No symptoms of local skin irritation at the ears of the animals and no signs of systemic toxicity were observed during the study period. Redness of the ear skin could not be detected, due to the colour of the test item.
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:
- Category 1 (skin sensitising) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The test item FAT 40865/A TE was found to be a skin sensitiser under the test conditions of this study.
- Executive summary:
An OECD Guideline 429 (local lymp node) assay was performed in accordance to GLP to assess for possible skin sensitising potential of test item FAT 40865/A.The test item was formulated in DMF at concentrations of 2, 5, and 10% (w/w). The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed by three pre-experiments. The animals did not show any signs of systemic toxicity or local skin irritation during the course of the study and no cases of mortality were observed. Redness of the ear skin could not be observed, due to the colour of the test item. In this study Stimulation Indices (S.I.) of 8.61, 8.47, and 8.89 were determined with the test item at concentrations of 2, 5, and 10% (w/w) in DMF, respectively. A clear dose response was not observed. However, all SI's clearly exceeded the threshold value of 3. The test item FAT 40865/A TE was found to be a skin sensitiser.
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.
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