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Diss Factsheets
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EC number: 203-661-5 | CAS number: 109-28-4
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read-across substance according to OECD guideline and GLP; narrative description of nature and degree of irritation/corrosion is limited.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides
- EC Number:
- 295-714-4
- EC Name:
- Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides
- Cas Number:
- 92128-22-8
- Molecular formula:
- not available
- IUPAC Name:
- Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides
- Test material form:
- other: liquid
- Details on test material:
- - Test material form: dark brown liquid
- Purity: >95%
- Date of receipt: 28 June 2002
- Expiry date: July 2003
- Storage conditions: at room temperature
- pH: measured at CIT, approximately 8.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMAL:
- Source: CEGAV, Saint Mars d'Egrenne, France
- Age at study initiation: 2-4 months
- Weight at study initiation: 3.2 kg
- Housing: polystyrene cage (48.2 cm x 58 cm x 36.5 cm) equipped with a food container and a water bottle
- Diet (e.g. ad libitum): ad libitum, 110 pelleted diet (UAR, Villemoisson, Epinay-sur-Orge, France)
- Water (e.g. ad libitum): ad libitum, drinking water filtered by a FG Millipore membrane (0.22 micron)
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL undiluted test substance
- Duration of treatment / exposure:
- 4 hours (right flank), 3 minutes (left flank)
- Observation period:
- 1 hour, 24, 48 and 72 hours after removal of the dressing
- Number of animals:
- 1
- Details on study design:
- TEST SITE
Right and left flank of test animal (application for 4 hours and 3 minutes, respectively); both flanks were clipped the day before treatment, and clipping was repeated on day 2. Untreated skin served as control.
COVER
Test item was placed on dry gauze pads which were then applied to the clipped flanks. Test item and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
After removal of the dressing, any residual test item was wiped off by means of a moistened cotton pad.
SCORING SYSTEM:
Erythema and eschar formation:
- no erythema: 0
- very slight erythema (barely perceptible): 1
- well-defined erythema: 2
- moderate to severe erythema: 3
- severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Oedema formation
- no oedema: 0
- very slight oedema (barely perceptible): 1
- slight oedema (edges of area well-defined by definite raising): 2
- moderate oedema (raised approximately 1 millimetre): 3
- severe oedema (raised more than 1 millimetre and extending beyond area of exposure): 4
Any other lesions were noted.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: only one animal used
- Time point:
- other: 1 hour after removal of dressing
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: after 3 minutes exposure
- Irritation parameter:
- edema score
- Basis:
- other: only one animal used
- Time point:
- other: 1 hour after removal of dressing
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: after 3 minutes exposure
- Irritation parameter:
- erythema score
- Basis:
- other: only one animal used
- Time point:
- other: 1 hour after removal of dressing
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: after 4 hours exposure
- Irritation parameter:
- edema score
- Basis:
- other: only one animal used
- Time point:
- other: 1 hour after removal of dressing
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: after 4 hours removal
- Irritant / corrosive response data:
- After a 3-minute or a 4-hour exposure, necrosis was noted at the application site 24 hours after removal of the dressing. The animal was then killed for ethical reasons. For details, see tables in section "any other information on results incl. tables".
- Other effects:
- A brown discoloration of the skin at the application sites was observed 1 hour after removal of the dressing after 3 minutes or 4 hours exposure.
Any other information on results incl. tables
Table 1. Irritation scores and other observations after 3 minutes exposure (scoring at 1 hour and 24 hours after removal of dressing).
Parameter |
Scores |
|
1 hour |
24 hours |
|
Erythema |
0 |
N |
Oedema |
0 |
LN |
Other |
C |
* |
h = hour
* = None
C = brown coloration of the skin
N = Necrosis
LN = scoring masked by necrosis
Table 1´2. Irritation scores and other observations after 4 hours exposure (scoring at 1 hour and 24 hours after removal of dressing).
Parameter |
Scores |
|
1 hour |
24 hours |
|
Erythema |
0 |
N |
Oedema |
0 |
LN |
Other |
C |
* |
h = hour
* = None
C = brown coloration of the skin
N = Necrosis
LN = scoring masked by necrosisApplicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions chosen, the test item is corrosive when applied topically to rabbits.
- Executive summary:
The potential of the test item EMULSAMINE AT-O to induce skin irritation was evaluated in rabbits according to OECD Guideline 404 and in compliance with GLP. In the first instance, the test item was applied for periods of 3 minutes and 4 hours to a single male New Zealand White rabbit. As the test item showed corrosive properties on this first animal, the study was considered complete and the test item was not evaluated on other animals.
A single dose of 0.5 mL of the undiluted test item was applied to the closely-clipped skin of one flank. The test item was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour and 24 hours after removal of the dressing.
After a 3-minute or a 4-hour exposure, necrosis was noted at the application site 24 hours after removal of the dressing. The animal was then killed for ethical reasons. It was concluded that, under the experimental conditions chosen, the test item is corrosive when applied topically to rabbits.
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