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EC number: 230-157-2 | CAS number: 6962-44-3
- 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
- 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:
- 2 009
- Report date:
- 2009
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:
- N-(2-methoxy-5-methylphenyl)acetamide
- EC Number:
- 230-157-2
- EC Name:
- N-(2-methoxy-5-methylphenyl)acetamide
- Cas Number:
- 6962-44-3
- Molecular formula:
- C10H13NO2
- IUPAC Name:
- N-(2-methoxy-5-methylphenyl)acetamide
- Details on test material:
- - Name of test material (as cited in study report): Acetkresidin TTRS
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V., Postbus 6174, NL - 5960 AD Horst / The Netherlands
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 15 - 25 g
- Housing: group housing
- Diet (e.g. ad libitum): pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: At least 5 days prior to the start of dosing under test conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 45-65
- Artificial light: 6.00 a.m. - 6.00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 5, 10, and 25%
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
A solubility experiment was performed according to the recommendations given by OECD 429. The highest test item concentration, which can be technically used was a 25 % (w/v) solution in dimethylformamide. Grinding of the test item and vortexing were necessary to prepare the solution.
To determine the highest non-irritant test concentration, a pre-test was performed in two animals. Two mice were treated with concentrations of 10 and 25% each on three consecutive days.
MAIN STUDY:
Topical Application
Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear lobe (left and right) with different test item concentrations of 5, 10, and 25% (w/v) in dimethylformamide. The application volume, 25 µL, was spread over the entire dorsal surface (ø 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
Five days after the first topical application, all mice were administered with 250 µL of 81.0 µCi/ml 3HTdR (corresponds to 20.2 µCi 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 Pentobarbital-Natrium.
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 µm 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 scintillation liquid and thoroughly mixed.
The level of 3HTdR incorporation was then measured on a ß-scintillation counter. Similarly, background 3HTdR levels were also measured in two 1ml-aliquots of 5 % trichloroacetic acid. The ß-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:
- EC3: 7.8% (w/v)
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 5%: 0.85 10%: 1.09 25%: 0.73
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Measurement DPM Control Group: 5166 5%: 4426 10%: 5628 25%: 3778
Any other information on results incl. tables
Test item concentration % (w/v) |
Group |
Measurement DPM |
Calculation |
Result |
||
DPM-BGa) |
number of lymph nodes |
DPM per lymph nodeb) |
S.I. |
|||
--- |
BG I |
144 |
--- |
--- |
--- |
--- |
--- |
BG II |
24 |
--- |
--- |
--- |
--- |
--- |
1 |
5166 |
5082 |
8 |
635.3 |
|
5 |
2 |
4426 |
4342 |
8 |
542.8 |
0.85 |
10 |
3 |
5628 |
5544 |
8 |
693.0 |
1.09 |
25 |
4 |
3778 |
3694 |
8 |
461.8 |
0.73 |
BG: Background (1 ml 5% trichloroacetic acid) in duplicate
1: Control Group
2-4: Test Group
S.I.: Stimulation Index
a): The mean value was taken from the figures BG I and BG II
b): Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled
The EC3 value could not be calculated, since all S.I.´s are below 3.
Viability / Mortality: No deaths occurred during the study period.
Clinical Signs: No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period. After 24 hours after the first application onwards the urine of the treated animals was discoloured, indicating the systemic distribution of the test item.
Body Weights: The body weight of the animals, recordedprior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age.
Ear Weights: The measured ear weights (punches) of all animals treated were recorded after sacrifice. A relevant increase in ear weights (punches) was not observed and a statistically significance of the ear weight was not determined.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test item Acetkresidin TTRS was not a skin sensitiser in this assay.
- Executive summary:
In the study the test item Acetkresidin TTRS dissolved in dimethylformamide was assessed for its possible contact allergenic potential.
For this purpose a local lymph node assay was performed using test item concentrations of 5, 10, and 25%.
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. After 24 hours after the first application onwards the urine of the treated animals was discoloured, indicating the systemic distribution of the test item. A relevant increase in ear weights (punches) was not observed and a statistically significance of the ear weight was not determined.
In this study Stimulation Indices (S.I.) of 0.85, 1.09, and 0.73 were determined with the test item at concentrations of 5, 10, and 25% in dimethylformamide, respectively.
The test item Acetkresidin TTRS was not a skin sensitiser in this assay.
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