Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 618-990-3 | CAS number: 939961-06-5
- 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:
- 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well perfomed 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)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 3-amino-N-(4-carbamoylphenyl)-4-methoxybenzamide hydrochloride
- EC Number:
- 618-990-3
- Cas Number:
- 939961-06-5
- Molecular formula:
- C15H15N3O3xClH
- IUPAC Name:
- 3-amino-N-(4-carbamoylphenyl)-4-methoxybenzamide hydrochloride
- Details on test material:
- purity: 94.7 %
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: 18.5 - 22.7 g
- Housing: single cages
- Diet: pelleted standard diet, (Harlan Laboratories GmbH, D-33178 Borchen) ad libitum
- Water: tap water, ad libitum, (Gemeindewerke, D-64380 Rossdorf)
- Acclimation period: At least 5 days prior to the start of dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): 30 -70
- Air changes (per hr):
- Photoperiod: artificial light 6.00 a.m. - 6.00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol:deionised water (70 : 30)
- Concentration:
- 0, 1, 5, 10 %
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
The highest test item concentration, which can be technically used was a 10 % suspension in methyl ethyl ketone. Due to the possibility of a reaction of the test item with the vehicle, ethanol:deionised water (70+30) was choosen as vehicle by the sponsor. A suspension of 10% could be achieved after warming for 30 min. at 37°C.
Two mice were treated with concentrations of 5, and 10 % on both ears each on three consecutive days. Clinical signs were recorded 24 ± 4 hours after each application and on day corresponding to the day of preparation of the main experiment. At the tested concentrations the animals did not show any signs of irritation or systemic toxicity.
MAIN STUDY
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 1, 5 and 10 % (w/v) in ethanol:deionised water (70+30). The application volume, 25 µl, was spread over the entire dorsal surface (diameter about 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).
Five days after the first topical application, all mice were administered with 250 µl of 85.2 µCi/ml 3HTdR (corresponds to 21.3µCi 3HTdR per mouse) by intravenous injection via a tail vein.
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 (200µm 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 ‘Ultima Gold’ scintillation liquid.
The level of 3HTdR incorporation was then measured on a ß-scintillation counter (Tricarb 2900 TR, Perkin Elmer (LAS) GmbH, D-63110 Rodgau). 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).
- Criteria used to consider a positive response:
A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the stimulation index.
- Second, that the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression. - 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 %
Experiment performed in July 2008.
The EC3 value was estimated to be < 5%. A precise calculation of the EC3 value was not possible since the S.I. was above the threshold of 3 even at the lowest tested concentration. The obtained values are within the expected range and the positive control experiment is considered fully valid.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Test item Calculation concentration Group Measurement number of DPM per % (w/v) DPM DPM-BG lymph nodes lymph node S.I. -- BG I 21 -- -- -- -- -- BG II 19 -- -- -- -- 0 1 4058 4038 8 504.8 1 2 3619 3599 8 449.9 0.89 5 3 3875 3855 8 481.9 0.95 10 4 2920 2900 8 362.5 0.72 BG = Background (1 ml 5% trichloroacetic acid) in duplicate 1 = Control Group 2-4 = Test Group S.I. = Stimulation Index The EC3 value could not be calculated, since all S.I.´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, 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.
The measured ear weights of all animals treated were recorded after sacrifice. A relevant increase in ear weights was not observed.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item Aminoanisoylaminobenzamid Hydrochlorid trocken was not a skin sensitiser under the described conditions.
- Executive summary:
In the study the test item Aminoanisoylaminobenzamid Hydrochlorid trocken dissolved in ethanol:deionised water (70+30) was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay (OECD 429)was performed using test item concentrations of 1, 5 and 10 %. The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. In this study Stimulation Indices (S.I.) of 0.89, 0.95 and 0.72 were determined with the test item at concentrations of 1, 5 and 10 % in ethanol:deionised water (70+30), respectively.
The test item Aminoanisoylaminobenzamid Hydrochlorid trocken was not a skin sensitiser in this assay.
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.