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EC number: 247-361-2 | CAS number: 25952-53-8
- 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- N'-(ethylcarbonimidoyl)-N,N-dimethylpropane-1,3-diamine monohydrochloride
- EC Number:
- 247-361-2
- EC Name:
- N'-(ethylcarbonimidoyl)-N,N-dimethylpropane-1,3-diamine monohydrochloride
- Cas Number:
- 25952-53-8
- Molecular formula:
- C8H17N3.ClH
- IUPAC Name:
- N-[3-(dimethylamino)propyl]-N'-ethylcarbodiimide hydrochloride
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Remarks:
- CBA/CaOlaHsD
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, 33178 Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: Obtained from controlled full barrier breeding facility (SPF).
- Age at study initiation: 8 to 9 weeks
- Weight at study initiation: ca. 20 g
- Housing: Full barrier in an air-conditioned room. Animals housed in groups of 5 in IVC cages containing saw fibre bedding.
- Diet (e.g. ad libitum): Free access to Altromin maintenance diet.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: At least 5 days.
- Indication of any skin lesions: Assessed ahead of study. Animals with lesions were not used.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C.
- Humidity (%): 55 +/- 10%
- Air changes (per hr): At least 10
- Photoperiod (hrs dark / hrs light): artificial light (12 hours light/dark cycle)
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- A solubility test was initially performed to define the vehicle and maximum concentration possible. the maximum technically applicable concentration was found to be 25% in DMSO. The concentrations used in the preliminary test were 25, 10 and 5 % in DMSO. Based on the observations in the preliminary test, concentrations of 1.25, 2.5 and 5% in DMSO were used in the main test.
- No. of animals per dose:
- 6 females used in the preliminary test (2 per group) and 5 females per group in the main test
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: 25% in DMSO maximum technically applicable concentration
- Irritation: No signs of irritation at the application site were noted.
- Systemic toxicity: Signs of systemic toxicity were noted in the form of clinical signs at both 10 and 25% in DMSO, and also mortality. Animals treated with 5% in DMSO showed no signs of toxicity.
- Ear thickness measurements: No effects of treatment on ear thickness
- Erythema scores: No signs of irritation
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: SI Index =/> 3 at one concentration.
TREATMENT PREPARATION AND ADMINISTRATION: The test substance was suspended in DMSO. The preparations were made immediately prior to dosing. DMSO was used as the vehicle and served as the negative contol.
Each mouse was treated by topical application of 25 µL of the selected solution onto the dorsal surface of each ear. Applications were performed once daily over three consecutive days. - Positive control substance(s):
- other: P-Phenylenediamine (CAS No. 106-50-3)
- Statistics:
- No relevant EC3 value could be calculated.
Results and discussion
- Positive control results:
- The results of the positive control assay (from the most recent reliability check) showed that the test system was working adequately.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 9.4
- Variability:
- Individual values 7.5 to 11.3
- Test group / Remarks:
- 1.25% in DMSO
- Parameter:
- SI
- Value:
- 6.6
- Variability:
- Individual values 1.7 to 11.2
- Test group / Remarks:
- 2.5% in DMSO
- Parameter:
- SI
- Value:
- 3.9
- Variability:
- Individual values 3.2 to 4.3
- Test group / Remarks:
- 5% in DMSO
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA: The proliferative response of lymph node cells was expressed as the number of radioactive disintergrations per minute (DPM/Node). Before DPM/Node values were calculated, background values were subtracted.
DETAILS ON STIMULATION INDEX CALCULATION: The ratio of 3H-methyl thymidine; incorporation into lymph node cells of test group animals relative to that recorded for control group animals.
EC3 CALCULATION: The EC3 value could not be calculated as all mean SI values were > 3.
CLINICAL OBSERVATIONS: All animals survived the observation period without showing clinical signs.
BODY WEIGHTS: All animals showed expected weight development.
Any other information on results incl. tables
Radioactive determination of test substance groups.
POS |
CPM |
Test item |
Conc. % |
Animal No. |
DPM |
DPM-Mean background |
DPM/node |
SI |
85 |
4019 |
Negative control |
NA |
16 |
8158 |
8144.4 |
4072.2 |
1.0 |
86 |
2506 |
17 |
5120 |
5106.4 |
2553.2 |
|||
87 |
1176 |
18 |
2398 |
2384.4 |
1192.2 |
|||
88 |
841 |
19 |
1726 |
1712.4 |
856.2 |
|||
89 |
7733* |
20 |
15908* |
Nd |
Nd |
|||
MV |
2135.5 |
MV |
4350.5 |
4336.9 |
2168.5 |
|||
SD |
1253.1 |
SD |
2539.2 |
2539.2 |
1269.6 |
|||
66 |
23830 |
Test substance |
1.25 |
1 |
49188 |
49174.4 |
24587.2 |
11.3 |
67 |
20608 |
2 |
42152 |
42138.4 |
21069.2 |
9.7 |
||
68 |
15870 |
3 |
32757 |
32743.4 |
16371.7 |
7.5 |
||
69 |
19494 |
4 |
40050 |
40036.4 |
20018.2 |
9.2 |
||
70 |
19610 |
5 |
40572 |
40558.4 |
20279.2 |
9.4 |
||
MV |
19882.4 |
MV |
40943.8 |
40930.2 |
20465.1 |
9.4 |
||
SD |
2546.9 |
SD |
5241.9 |
5241.9 |
2620.9 |
1.2 |
||
73 |
11357 |
Test substance |
2.5 |
6 |
22994 |
22980.4 |
11490.2 |
5.3 |
74 |
3488 |
7 |
7184 |
7170.4 |
3585.2 |
1.7 |
||
75 |
12869 |
8 |
26545 |
26531.4 |
13265.7 |
6.1 |
||
76 |
18211 |
9 |
37639 |
37625.4 |
18812.7 |
8.7 |
||
77 |
23187 |
10 |
48576 |
48562.4 |
24281.2 |
11.2 |
||
MV |
12822.4 |
MV |
28587.6 |
28574 |
14287 |
6.6 |
||
SD |
6644.4 |
SD |
13964.5 |
13964.5 |
6982.3 |
3.2 |
||
78 |
8893 |
Test substance |
5 |
11 |
18133 |
18119.4 |
9059.7 |
4.2 |
79 |
9074 |
12 |
18538 |
18524.4 |
9262.2 |
4.3 |
||
80 |
6714 |
13 |
13677 |
13663.4 |
6831.7 |
3.2 |
||
81 |
15144** |
14 |
31954** |
Nd |
Nd |
Nd |
||
82 |
8159 |
15 |
16595 |
16581.4 |
8290.7 |
3.8 |
||
MV |
8210 |
MV |
16735.8 |
16722.2 |
8361.1 |
3.9 |
||
SD |
929.2 |
SD |
1908.9 |
1908.9 |
954.5 |
0.4 |
||
97 |
7 |
Background (scintillation fluid and trichloroacetic acid) |
NA |
NA |
14 |
|
|
0 |
98 |
7 |
15 |
|
|
||||
99 |
8 |
15 |
|
|
||||
100 |
5 |
10 |
|
|
||||
101 |
7 |
14 |
|
|
||||
MV |
6.8 |
MV |
13.6 |
0 |
0 |
|||
SD |
1 |
SD |
1.9 |
|
|
* – outlier failed Nalimov
** – Outlier failed Grubbs, Nalimov and Dixon
POS – Position in counter
CPM – Counts per minute
DPM – Disintegrations per minute
MV – mean value
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Based on the study results, the test substance is expected to have skin sensitising properties. However, no EC3 value could be calculated to allow for sub-categorisation in terms of the CLP regulation (1272/2008, as amended).
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