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Diss Factsheets
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EC number: 951-985-7 | 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
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental Phase:16 December 2020 to 19 January 2021.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
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
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-amino-N-{6-[(2-aminophenyl)formamido]-2-{3-[(2-aminophenyl)formamido]propyl}hexyl}benzamide
- EC Number:
- 951-985-7
- Molecular formula:
- C30H38N6O3
- IUPAC Name:
- 2-amino-N-{6-[(2-aminophenyl)formamido]-2-{3-[(2-aminophenyl)formamido]propyl}hexyl}benzamide
- Test material form:
- solid: crystalline
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Female CBA/CaCrl strain mice were supplied by Charles River (UK) Ltd, Margate, UK.).
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 9 to 10 weeks
- Weight at study initiation: 17 to 20g. Individual body weights were within ±20% of the mean body weight for mice on the study.
- Housing: Animals were housed in groups of up to five during acclimatisation and in pairs. From day 1 the preliminary study animal was individually housed from and the main study animals were housed in pairs. Bedding was provided on a weekly basis to each cage by use of clean European softwood bedding (Datesand Ltd., Manchester, UK).
. - Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 - 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 40 to 70%
- Air changes (per hr): At least fifteen per hour
Photoperiod (hrs dark / hrs light): 12 hours in light, 12 hours in darkness
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Remarks:
- The vehicle was chosen because it produced the highest suitable concentration (25% w/v) out of the vehicles listed in the protocol.
- Concentration:
- Control = vehicle only, low dose = 5 % w/v test substance, mid-dose = 10% w/v test substance, high dose = 25% w/v test substance
- No. of animals per dose:
- Four per dose group.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The positive control article produced a Stimulation Index of 4.48, demonstrating adequate performance of the assay.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- ca. 1.29
- Test group / Remarks:
- 5 % w/v
- Key result
- Parameter:
- SI
- Value:
- ca. 1.72
- Test group / Remarks:
- 10 % w/v
- Key result
- Parameter:
- SI
- Value:
- ca. 2.112
- Test group / Remarks:
- 25% w/v
Any other information on results incl. tables
Mortality
There were no deaths on the study.
Clinical Signs
There were no clinical signs indicative of a systemic effect of treatment among mice treated with the vehicle or with 5, 10 or 25% w/v formulations of the test article.
The vehicle and test formulation application sites remained free of irritation.
Greasy fur to the back of the ears and neck were observed in all Group 5 animals from Day 1 to Day 5 indicative of the positive control vehicle being acetone/olive oil (4:1 (v/v)).
Body Weights
There was no indication of a treatment related effect on body weight.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the result from the Local Lymph Node Assay, the test substance was concluded not have the potential to cause skin sensitisation.
- Executive summary:
Introduction
This study was conducted to assess the potential of the test article, N,N'-(2-(4-(2-aminobenzamido)butyl)pentane-1,5-diyl)bis(2-aminobenzamide), to cause skin sensitisation in the mouse. The method used was deigned to meet the requirements of the following guidelines:
- OECD Guidelines for Testing of Chemicals Method 429 (adopted 22 July 2010).
- Method B42 of Council Regulation (EC) No 440/2008
Method
Following a preliminary screening test using a 25% w/v formulation, the test article was prepared for administration at 5, 10 or 25% w/v in dimethyl sulphoxide (DMSO).
Groups of four female CBA / CaCrl mice were subjected to topical applications of vehicle control, positive control or of one of the test formulations to the outer aspect of the auditory pinnae once daily on Days 1, 2 and 3. On Day 6 a 20 μCi dose of tritiated 3H-methyl thymidine was injected intravenously into each mouse. Approximately five hours later the auricular lymph nodes were recovered from each animal. The pairs of nodes from each animal were pooled and suspensions of the cellular components of the lymph nodes were prepared in 5% w/v trichloroacetic acid and processed through a scintillation counter.
Test results are expressed in terms of Stimulation Indices and the threshold level for the Stimulation Index to be considered a positive indicator of the potential to cause skin sensitisation is 3.0.
Results
Concentration of Test Article in Applied Formulation (% w/v)
5%
10%
25%
Stimulation Index
1.29
1.72
2.12
The positive control article produced a Stimulation Index of 4.48, demonstrating adequate performance of the assay.
Conclusion
The test substance, N,N'-(2-(4-(2-aminobenzamido)butyl)pentane-1,5-diyl)bis(2-aminobenzamide) did not induce skin sensitisation in the Local Lymph Node Assay and is considered not to be a skin sensitser.
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