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EC number: 276-769-3 | CAS number: 72705-22-7
- 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:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD study with GLP
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:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Ammonium 4-acetoacetylamino-5-methoxy-2-methylbenzenesulphonate
- EC Number:
- 276-769-3
- EC Name:
- Ammonium 4-acetoacetylamino-5-methoxy-2-methylbenzenesulphonate
- Cas Number:
- 72705-22-7
- Molecular formula:
- C12H15NO6S.H3N
- IUPAC Name:
- ammonium 4-acetoacetylamino-5-methoxy-2-methylbenzenesulphonate
- Details on test material:
- purity: 95.6 % (contains residual water)
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Strain: CBA/CaOlaHsd
- Source: Harlan Netherlands, B.V. Postbus 6174, NL - 5960 AD Horst / The Netherlands
- Age at study initiation: 7 - 8 weeks (beginning of acclimatisation)
- Weight at study initiation: 18.6 - 22.1 g
- Housing: single in Makrolon Type I cages, with wire mesh top
- Diet: pelleted standard diet, ad libitum (Harlan Winkelmann GmbH, D-33178 Borchen)
- Water: tap water, ad libitum, (Gemeindewerke, D-64380 Rossdorf)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): 30 - 86
- Photoperiod: artificial light 6.00 a.m. - 6.00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 0 %, 6.25 %, 12.5 %, 25 %
- No. of animals per dose:
- 4
- Details on study design:
- Observations:
Mortality / Viability: once daily (week day) from experimental start to necropsy.
Body weights: prior to the first application and prior to treatment with 3HTdR.
Clinical signs (local / systemic): once daily (week day). Especially the treatment sites were observed carefully. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Positive control substance: alpha-Hexylcinnamaldehyde
Vehicle: acetone:olive oil (4+1)
concentrations: 5 %, 10 % , 25 %
S.I . 2.04 6.31 12.45
EC3-value: 6.1
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Test item Measurement Calculation concentration Group DPM DPM-BG number of DPM per Result % (w/v) lymph nodes lymph node S.I. --- BG I 15.43 --- --- --- --- --- BG II 16.47 --- --- --- --- 0 1 6052.97 6037.0 8 754.6 --- 6.25 2 7270.68 7254.7 8 906.8 1.20 12.5 3 11548.60 11532.7 8 1441.6 1.91 25 4 10917.00 10901.1 8 1362.6 1.81 BG = Background The EC3 Value could not be calculated, since all SI´s are below 3.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see below
Any other information on results incl. tables
No deaths occurred during the study period.
No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period.
The body weight of the animals was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was not a skin sensitiser under the described conditions.
- Executive summary:
In order to study a possible contact allergenic potential a Local Lymph Node Assay (OECD 429) was performed with the substance.Three groups each of four female mice were treated daily with the test item at concentrations of 6.25, 12.5, and 25% (w/v) in DMSO 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 (DMSO) 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 ß-scintillation counter.
All treated animals survived the scheduled study period and no signs of toxicity were observed.
In this study Stimulation Indices of 1.20, 1.91, and 1.81 were determined with the test item at concentrations of 6.25, 12.5, and 25% in DMSO. The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3.
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