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EC number: 246-438-8 | CAS number: 24731-73-5
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well performed GLP study according to recent OECD TG.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 24 April 2002
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- N,N'-1,4-phenylenebis[3-oxobutyramide]
- EC Number:
- 246-438-8
- EC Name:
- N,N'-1,4-phenylenebis[3-oxobutyramide]
- Cas Number:
- 24731-73-5
- Molecular formula:
- C14H16N2O4
- IUPAC Name:
- 3-oxo-N-[4-(3-oxobutanamido)phenyl]butanamide
- Details on test material:
- - Name of test material (as cited in study report): Diacetessig-p-phenylendiamid (DAEP)
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Test system Mice, CBA/CaOlaHsd
Rationale: Recognised as the recommended test system
Source: Harlan Netherlands, B.V. Postbus 6174, NL - 5960 AD Horst / The Netherlands
Number of animals for the pre-test (non-GLP): 2 females
Number of animals for the main study: 16 females
Number of animals per group: 4 females (nulliparous and non-pregnant)
Number of test groups: 3
Number of control (vehicle) groups: 1
Age: 6 - 7 weeks (beginning of acclimatization)
Identification: Single caging. The animals will be distributed into the test groups at random and identified by cage number.
Acclimatisation: Under test conditions after health examination. Only animals without any visible signs of illness will be used for the study.
The animals were kept conventionally. The experiment was conducted under standard laboratory conditions.
Housing: single
Cage Type: Makrolon Type I, with wire mesh top (EHRET GmbH, D-79302 Emmendingen)
Bedding: granulated soft wood bedding (Harlan Winkelmann GmbH, D-33178 Borchen)
Feed: pelleted standard diet, ad libitum (Harlan Winkelmann GmbH, D-33178 Borchen)
Water: tap water, ad libitum (Gemeindewerke, D-64380 Rossdorf)
Environment: temperature 22 + 3°C
Relative humidity 30-70%
Artificial light 6.00 a.m. - 6.00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- Group 1 (vehicle control): 0%
Group 2: 5 % (w/v)
Group 3: 10 % (w/v)
Group 4: 20 % (w/v) - No. of animals per dose:
- 4
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- EC3 = 18.2 % (w/v)
EC3 = Estimated concentration for a S.I. of 3.
Any other information on results incl. tables
Calculation and Results of Individual Data
Vehicle: DMSO
Test item |
Group |
Measurement |
Calculation |
Result |
||
DPM-BGa) |
number of |
DPM per |
S.I. |
|||
--- |
BG I |
18.80 |
--- |
--- |
--- |
--- |
--- |
BG II |
101.60 |
--- |
--- |
--- |
--- |
--- |
CG 1 |
3924.46 |
3864.30 |
8 |
483.00 |
|
5 |
TG 2 |
4819.49 |
4759.30 |
8 |
594.90 |
1.23 |
10 |
TG 3 |
5621.87 |
5561.70 |
8 |
695.20 |
1.44 |
20 |
TG 4 |
5692.13 |
5631.90 |
8 |
704.00 |
1.46 |
BG = Background (1 ml 5% trichloroacetic acid) in duplicateCG = Control Group
TG = 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 stimulation indices are below 3.
Viability / Mortality
No deaths occurred during the study period.
Clinical Signs
The animals did not show any clinical signs of toxicity after the first and second application. After the third application the highest dose (20%) induced redness of the ear skin of all 4 animals of the group. At the mid dose of 10% the ear skin of two animals was only slighly reddend.
Body Weights
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.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test item Diacetessig-p-phenylendiamid (DAEP) was not a skin sensitiser under the described conditions.
- Executive summary:
In the study the test item Diacetessig-p-phenylendiamid (DAEP) dissolved in DMSO 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 20%.
The animals did not show any clinical signs of toxicity after the first and second application. After the third application the mid dose (10 %) induced slight redness of the ear skin of two animals of the group. At the high dose of 20 % the ear skin of all 4 animals was reddend after the third application. No cases of mortality were observed.
In this study Stimulation Indices (S.I.) of 1.23, 1.44 and 1.46 were determined with the test item at concentrations of 5, 10 and 20% (w/v) in DMSO, respectively.
The test item Diacetessig-p-phenylendiamid (DAEP) was not a skin sensitiser under the described conditions.
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