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EC number: 610-472-5 | CAS number: 49707-23-5
- 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:
- 2009-10-01 to 2010-01-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well performed study according to OECD Technical Guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- dated 24 April 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate attached to the report
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- N-(2,2-dimethoxyethyl)prop-2-enamide
- EC Number:
- 610-472-5
- Cas Number:
- 49707-23-5
- Molecular formula:
- C7 H13 N1 O3
- IUPAC Name:
- N-(2,2-dimethoxyethyl)prop-2-enamide
- Details on test material:
- - Sponsor's identification: NAAADA
- Container: plastic flask (n=1)
- Quantity: 51.80g (container and contents)
- Batch no: 700090909
- Production date: 09 September 2009
- CAS No of the main ingredients: 2226-96-2
- Date received: 16 September 2009
- Form: liquid
- Colour: yellow
- Storage: +4°C +/-4°C
- Expiry date: 09 January 2010
- Purity: >96%
- The item was used as supplied
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elevage Janvier (F-53941 Le Genest Saint Isle)
- Age at study initiation: 8 weeks
- Animals were nulliparous and non-pregnabt
- Weight at study initiation: 20.3 - 23.7g
- Housing: suspended solid-floor polypropylene cages furnished with soft woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12hrs / 12hrs
- Animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 0%, 25%, 50%, 100%
- No. of animals per dose:
- 4 females per dose
- Details on study design:
- PRELIMINARY STUDY
- Preliminary screening using one mouse
- The mouse was treated with 25µL of the undiluted test item
- Dorsal surface of each ear was treated on three consecutive days (d1, d2, d3)
- Daily observation of the treated animal on d1, d2, d3, d4, d5 and d6
- Any signs of toxicity or excessive local irriation noted during this period were recorded
- Body weight was recorded on day 1 prior to treatment and on day 6
- No systemic toxicity or excessive local reactions observed
MAIN STUDY
- Groups of four mice per each concentration
- Group 1: 4 females with vehicle only --> 0% of test item
- Group 2: 4 females with 25% test item
- Group 3: 4 females with 50% test item
- Group 4: 4 females with 100% test item
- An additional mouse was treated in each group in case of problems which may occur during the study, in particular during excision of lymph nodes
- Mice were treated by daily application of 25µL of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days
- Test item formulation was administered using an automatic micropipette and spread over the dorsal surface using the tip of the pipette
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Ear thickness and cell proliferation
- See specific details under: "Any other information on materials and methods incl. tables"
CRITERIA USED TO CONSIDER A POSITIVE RESPONSE:
- The test item will be regarded as a sensitiser if at least one concentration of the test item results is greater than 1.4 compared to control values
- Any test item failing to produce a SI<1.4 will be classified as a "non sensitiser"
- % increase in ear thickness between day 1 and day 6 - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- See attached tables (historical controls)
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks:
- at 25 %
- Value:
- 0.68
- Variability:
- pooled approach
- Test group / Remarks:
- 4 animals
- Parameter:
- SI
- Remarks:
- at 50 %
- Value:
- 1.21
- Variability:
- pooled approach
- Test group / Remarks:
- 4 animals
- Parameter:
- SI
- Remarks:
- at 100 %
- Value:
- 0.9
- Variability:
- pooled approach
- Test group / Remarks:
- 4 animals
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Other method: cell counting and ear thickness
Any other information on results incl. tables
PRELIMINARY SCREENING TEST
Clinical observations, bodyweight and mortality data are given in Table 1 (attached).
No signs of systemic toxicity were noted.
Based on this information the dose levels selected for the main test were 25% (v/v), 50% (v/v) indimethylformamide and 100%.
CLINICAL OBSERVATIONS AND MORTALITY
Individual clinical observations and mortality data for test and control animals are given in Table 2 (attached).
No mortality and no signs of systemic toxicity were noted in the test and controls animals during thetest.
WEIGHT EVOLUTION
Individual bodyweights and bodyweight changes for test and control animals are given in Table 3 (attached).
Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period.
ESTIMATION OF THE PROLIFERATIVE RESPONSE OF LYMPH NODE CELLS
The results of proliferation assay are given in Table 4 (given here and also attached).
Table 4: Cell count, Stimulation index and calculation of EC1.4
Groups |
Test item |
Cell count / groups |
Stimulation Index |
Result |
EC1.4value |
1 |
DMF (Dimethylformamid) |
23.80 |
n.a |
n.a |
n.a. |
2 |
25% |
16.28 |
0.68 |
Negative |
n.a. |
3 |
50% |
28.83 |
1.21 |
Negative |
|
4 |
100% |
21.45 |
0.90 |
Negative |
Stimulation Index = Cell count of treated group / Cell count of control group
EC1.4 value: Theorical concentration resulting in a SI value of 1.4
EC1.4=c + [(1.4 – d) / (b – d)] x (a – c)
Legend:
a = the lowest concentration giving stimulation index > 1.4
b = the actual stimulation index caused by a
c = the highest concentration failing to produce a stimulation index of 1.4
d = the actual stimulation index caused by c
No stimulation index of more than 1.4 was recorded for the three concentrations of the test item.
The Stimulation Index (SI) calculated by pooled approach was respectively 0.68, 1.21and 0.90 for thetreated group at 25%, 50% and 100%.
LOCAL IRRITATION
The results of ear thickness measurement and weight of skin biopsy are given in Tables 5 (attached) and 6 (attached).
No cutaneous reactions were observed at the concentrations of 25%, 50% and 100%.
No significant increase in ear thickness and in ear weight was recorded at the concentrations of 25%,50% and 100%. Therefore, the test item must be considered “non irritant” at the three concentrations.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- In view of these results, under these experimental conditions, the test item NAAADA is considered to be not a skin sensitiser in accordance with the criteria for classification, packaging and labelling of dangerous substances and preparations of the EEC Directives 67/548, 2001/59 and 99/45. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (Regulation (EC) No. 1272/2008), the test item is not be classified. No signal word and hazard statement are required.
- Executive summary:
The test was performed to assess the skin sensitisation potential of the test item NAAADA in the CBA/J strain mouse following topical applications to the dorsal surface of the ear.
Three groups of four animals, were treated for three consecutive days (D1, D2, D3) with 50 µL (25 µLper ear) of the test item as a solution in dimethylformamide (DMF) at concentrations of 25%, 50%(v/v) and 100%. A further group of four animals was treated with DMF.
On D6, the proliferation of lymphocytes in the draining auricular lymph nodes was determined by cellcounting. The experimental protocol was established accordingthe OECD Guideline n°429 datedApril 24th, 2002 and the test method B. 42 of the council regulation No.440/2008.
No mortality and no signs of systemic toxicity were noted in the test and control animals during thetest.
No cutaneous reaction was observed.
No significant increase in ear thickness and in ear weight was recorded at the concentrations of 25%, 50% and 100%. Therefore, the test item must be considered “non irritant” at the three concentrations.
The Stimulation Index (SI) calculated by pooled approach was 0.68, 1.21 and 0.90 for the treatedgroups at 25%, 50%, and 100%, respectively.
In view of these results, under these experimental conditions, the test item NAAADA is considered to be not a skin sensitiser in accordance with the criteria for classification, packaging and labelling ofdangerous substances and preparations of theEEC Directives 67/548, 2001/59 and 99/45. Nosymbol and risk phrase are required.
In accordance with the Globally Harmonized System (Regulation (EC) No 1272/2008), the test item is not to be classified in category 1. No signal word and hazard statement are required.
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