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EC number: 619-946-6 | CAS number: 890707-29-6
- 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:
- supporting study
- Study period:
- April 2009 - May 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-Amino-5-cyano-N,3-dimethylbenzamide
- Cas Number:
- 890707-29-6
- Molecular formula:
- C10H11N3O
- IUPAC Name:
- 2-Amino-5-cyano-N,3-dimethylbenzamide
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/JHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley, Frederick, Maryland
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Approximately 10 weeks old
- Weight at study initiation: 21.6-22.8 g
- Housing: During dosing and resting phases of the study, animals were housed singly in stainless steel, wire-mesh cages suspended above cage boards. After final weighing (test Day 5) until sacrifice, animals were housed 1 group per plastic shoebox cage with bedding.
- Diet: PMI® Nutrition International, LLC Certified Rodent LabDiet® #5002, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: For a minimum of 6 days
- Indication of any skin lesions: No
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26
- Humidity (%): 30-70
- Air changes (per hr): Not reported
- Photoperiod: Alternating 12-hour light and dark cycles
- IN-LIFE DATES: 15 April 2009 - 21 April 2009
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 0% (vehicle control), 1%, 10%, 20%, or 40% test substance
- No. of animals per dose:
- 5 female
- Details on study design:
- Five groups of 5 female CBA/JHsd mice were dosed for 3 consecutive days with 0% (vehicle control), 1%, 10%, 20%, or 40% test substance. Dimethylsulfoxide (DMSO) was used as the diluting vehicle. One group of 5 female mice was dosed for 3 consecutive days with 25% hexylcinnamaldehyde (HCA) in DMSO as a positive control. Animals were assigned to dose groups by computerised randomisation so that individual body weights did not vary more than 20% from the group mean.
On each day of dosing (test Days 0-2), 25 μL of test or control substance were administered topically to the dorsum of each mouse ear. Test Days 3-4 were days of rest followed by intravenous (tail vein) injection of 20 μCi of ³H-thymidine per mouse on test Day 5.
Approximately 5 hours after the injection, animals were sacrificed by carbon dioxide asphyxiation, draining auricular lymph nodes were removed, and single cell suspensions were prepared. The single cell suspensions were incubated at 2-8°C overnight. On test day 6, the single cell suspensions were counted on a beta counter and reported as disintegrations per minute (dpm).
A stimulation index (SI) was derived for each experimental group by dividing the mean dpm of each experimental group by the mean dpm of the vehicle control group. Statistically significant increases in cell proliferation in the test concentration groups compared to the vehicle control group and/or SIs of greater than or equal to 3.0 indicated a positive response. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- A 25% concentration of the positive control, HCA, produced a dermal sensitisation response in mice, SI = 6.79. Therefore, the LLNA test system was valid for this study.
In vivo (LLNA)
Results
- Key result
- Parameter:
- SI
- Value:
- < 3
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION:
Statistically significant increases in cell proliferation measurements compared to the vehicle control group were observed at the 10%, 20%, and 40% test concentrations. However, stimulation indexes of less than 3.0 were observed at all test concentrations of the test substance. Therefore, the EC3 value (the estimated concentration required to induce a threshold positive response, i.e., stimulation index = 3) for the test substance under the conditions of this study was not calculable.
CLINICAL OBSERVATIONS:
No clinical signs of toxicity were observed in the study. Stained skin/fur was observed on the ear of one mouse dosed with 40% test substance concentration.
BODY WEIGHTS:
No statistically significant differences in mean body weights and body weight gains compared to the vehicle control group were observed at any test concentration.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test substance did not produce a dermal sensitisation response in mice.
- Executive summary:
The objective of this study was to evaluate the potential of the test substance to produce a dermal sensitisation response in mice using the local lymph node assay (LLNA) according to OECD Guideline 429.
Five groups of 5 female CBA/JHsd mice were dosed for 3 consecutive days with 0% (vehicle control), 1%, 10%, 20%, or 40% test substance on both ears. Dimethylsulfoxide (DMSO) was used as the diluting vehicle. One group of 5 female mice was dosed for 3 consecutive days with 25% hexylcinnamaldehyde (HCA) in DMSO as a positive control. On test Day 5 of the assay, mice received ³H-thymidine by tail vein injection and were sacrificed approximately 5 hours later. The cell proliferation in the draining auricular lymph nodes of the ears of each mouse from the test substance groups was then evaluated and compared to the vehicle control group.
No statistically significant differences in mean body weights and body weight gains compared to the vehicle control group were observed at any test concentration. No clinical signs of toxicity were observed in the study. Stained skin/fur was observed on the ear of one mouse dosed with 40% test substance concentration.
Statistically significant increases in cell proliferation measurements compared to the vehicle control group were observed at the 10%, 20%, and 40% test concentrations. However, stimulation indexes (SI) of less than 3.0 were observed at all test concentrations. Therefore, the EC3 value (the estimated concentration required to induce a threshold positive response, i.e., stimulation index = 3) for the test substance under the conditions of this study was not calculable. Based on these data, the test substance is not a dermal sensitiser.
A 25% concentration of the positive control, HCA, produced a dermal sensitisation response in mice, SI = 6.79. Therefore, the LLNA test system was valid for this study. Under the conditions of this study, the test substance did not produce a dermal sensitisation response in mice.
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