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EC number: 701-369-7 | 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
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- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
- Biodegradation
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- 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
Endpoint summary
Administrative data
Description of key information
Available information indicates that Oleyl tripropylenetetramine is corrosive to skin.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 February 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Substance as described in Chapter 1.1
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Belton, Leics, England.
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1.0 kg
- Housing: The animal was individually housed in a labeled cage with perforated floor and shelter
- Diet (e.g. ad libitum): Pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad®, Mucedola, Milanese, Italy) approximately 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least three times a week.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: The acclimatization period was at least 5 days before the start of treatment under laboratory conditions.
A health inspection was performed prior to the commencement of treatment, to ensure that the animal was in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from abnormalities.
Results of analysis for diet (nutrients and contaminants), hay and water were assessed and did not reveal any findings that were considered to have affected the study integrity. All certificates and results of analysis are retained in the NOTOX archives.
Animal specifications (sex, age and body weight) are specified in the attached table.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.8 - 20.6ºC
- Humidity (%): 44 - 74%
Cleaning procedures in the room might have caused the temporary fluctuations above the optimal maximum level of 70% for relative humidity. Based on laboratory historical data, these fluctuations were considered not to have affected the study integrity.
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 02 February 2010 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams - Duration of treatment / exposure:
- Single application.
- Observation period:
- up to 4 hours after the first application when the single treated animal was sacrificed for ethical reasons.
- Number of animals:
- 1 (based on the severe skin reactions, no further animals were exposed to the test substance)
- Details on study design:
- STUDY DESIGN
The study was performed in a stepwise manner and started with the treatment of one animal (sentinel) with a stepwise exposure regime. Based on the severe skin reactions, no further animals were exposed to the test substance.
TEST SUBSTANCE PREPARATION
The test substance was applied as delivered by the sponsor.
TEST SITE
Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm).
REMOVAL OF TEST SUBSTANCE
After each removal of a dressing, the treated skin was cleaned of residual test substance using water and ethanol.
After the final observation, the animal was sacrificed by intra-venous injection of Euthasol® 20% (AST Farma BV, Oudewater, The Netherlands).
OBSERVATIONS
Mortality/Viability: Twice daily.
Toxicity: At least once daily.
Body Weight: Day of treatment (prior to application).
Necropsy: No necropsy was performed.
The skin reactions of all visible treated sites were assessed immediately after removal of a dressing. The irritation scores and a description of all other (local) effects were recorded. Adjacent areas of untreated skin of the animal served as controls.
SCORING SYSTEM:
The irritation was assessed according to the following numerical scoring system. At each observation, the highest scores given were recorded:
Erythema and eschar formation:
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) *
*. Where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the maximum grade for erythema (= 4) was given.
Oedema formation:
0: No oedema
1; Very slight oedema (barely perceptible)
2: Slight oedema (edges of area well-defined by definite raising)
3: Moderate oedema (raised approximately 1 millimeter)
4: Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure) - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (maximum score)
- Time point:
- other: 3 minutes
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 4 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (maximum score)
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 3 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (maximum score)
- Time point:
- other: 4 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: Animal sacrificed for ethical reasons immediately after the observation.
- Remarks on result:
- other: Dark-brown discolouration surrounded by grey discolouration at the edges of the application area, a sign of necrosis. This observation prevented erythema reading, hence the maximum grade for erythema (=4) was given.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Reversibility:
- other: Not possibe to determine due to animal sacrified for ethical reasons after 4 hours exposure
- Remarks on result:
- not determinable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (maximum score)
- Time point:
- other: 3 minutes, 1 and 4 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 4 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (maximum score)
- Time point:
- 24/48/72 h
- Reversibility:
- other: Not possible to determine due to animal sacrified for ethical reasons after 4 hours exposure.
- Remarks on result:
- not determinable
- Irritant / corrosive response data:
- A 3-minute exposure to 0.5 g of Oleyl tripropylenetetramine resulted in very slight erythema at 1 and 4 hours after exposure.
A 1-hour exposure resulted in very slight erythema immediately after exposure and in well defined erythema at 3 hours after exposure.
A 4-hour exposure resulted in dark brown discolouration surrounded by grey discolouration at the edge of the application area (sign of necrosis) immediately after exposure.
Tables containing individual irritation scores are specified in the attached table. - Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Oleyl tripropylenetetramine should be classified as : skin corrosive (Category 1C).
- Executive summary:
One rabbit was exposed to three samples of 0.5 grams of Oleyl tripropylenetetramine applied to separate skin-sites on intact, clipped skin using a semi-occlusive dressing. The exposure periods were 3 minutes, 1 hour and 4 hours, respectively. Skin reactions were assessed up to 4 hours after the 3-minute exposure. Based on severe skin reactions, no further animals were exposed to the test substance.
A 3-minute exposure to 0.5 g of Oleyl tripropylenetetramine resulted in very slight erythema at 1 and 4 hours after exposure.
A 1-hour exposure resulted in very slight erythema immediately after exposure and in well defined erythema at 3 hours after exposure.
A 4-hour exposure resulted in dark brown discolouration surrounded by grey discolouration at the edge of the application area (sign of necrosis) immediately after exposure.
Sticky or dry remnants of the test substance were present on the skin after exposure.
The dark brown discolouration surrounded by grey discolouration at the edge of the application area are signs of necrosis. Following this observation, the animal was sacrificed for humane reasons. These severe skin reactions are expected to result in deep and thick scab formation with possible ruptures of the scab, or the scab may drop off exposing scar tissue. Overall, these skin reactions were considered evidence of full thickness destruction of the skin, and hence no further animals were tested.
Based on these results and according to the:
- Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007), Oleyl tripropylenetetramine should be classified as : skin corrosive (Category 1C).
- Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures, Oleyl tripropylenetetramine should be classified as Corrosive (Category 1C) and labeled as H314: Causes severe skin burns and eye damage.
Reference
Sticky or dry remnants of the test substance were present on the skin after exposure.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oleyl dipropylenetriamine was evaluated in an in vivo dermal irritation/corrosion study in rabbits (NOTOX, 491219, 2010). Exposure of the skin of one animal for 4 hours with oleyl dipropylenetriamine resulted to evidence of full thickness destruction of the skin, and hence no further animals were tested. It was concluded that Oleyl tripropylenetetramine should be classified as skin corrosive (Category 1C).
For the evaluation of dermal corrosion/irritation for REACH substances of various categories of Fatty amines have recently been tested. Available data and practical experience indicated that these substances are corrosive to the skin. However, the information was generally incomplete, often inconsistent and of low validity. For support in the dossiers it was considered to perform the recommended in vitro dermal corrosion studies using human epidermal skin constructs to have adequate endpoint coverage. By comparing the more objective results from these studies, they were thought to be useful to demonstrate classification, in the support of the categories, and for inter- and extrapolation for borderline cases.
Unexpectedly, all the studies performed, including with the polyamine products, indicated that these substances are NOT corrosive in these in vitro test systems using human epidermis constructs, showing viability scores after 3 minutes and 1 hour not much different from control. Also for other fatty nitrile derivatives the same results were obtained.
To evaluate the validity of the in vitro test systems for these substance a few further studies were performed to validate the results within vivostudies.
In the interest of animal welfare and to minimize any testing likely to produce severe responses in animals, it was decided not to perform furtherin vivocorrosion studies in rabbits to confirm their corrosive properties.
Overview available data on dermal corrosion for polyamines (In bold results on Oleyl tripropylene tetramine):
|
dipropylene triamine |
Tripropylene tetraamine |
dipropylene triamine (branched) |
Positive control |
||||
Based on FA: |
Coco |
Tallow |
Oleyl |
Tallow |
Oleyl |
C12 |
Tallow |
|
Skin corrosion - viability in vitro:3 min 1 hour |
Non-Cor. 22% |
Non-Cor. 96% |
Non-Cor. 89% |
Not possible |
Non-Cor. 85% |
Corrosive 42% |
- |
Corrosive 6-9% |
Skin corrosion -in vivo |
- |
- |
- |
Corr.1C |
Corr.1C |
Corr.1B (3 min) |
Corr.1B (3 min) |
|
(In vitro dermal corrosion: Results considered corrosive when viability is below 50% following 3 minutes, or below 15% following 1 hour exposure)
None of the substances reached a viability indicating corrosion following 1 hour exposure, even in a case where in vivo results show corrosion following only 3 minutes exposure. Although in that case the 3 -minute exposure showed a viability below 50% thus indicating corrosion.
The mode of action follow from their structure, consisting of an apolar fatty acid chain and a polar end of a primary amine (linked to one or two secondary amine). The structure can disrupt the cytoplasmatic membrane, leading to lyses of the cell content and consequently the death of the cell.
The similar physicochemical properties among the group of polyamines, also suggest similar behaviour and toxicological responses for these substances.
Corrosive to eyes is assumed for substances for which dermal corrosion has been established.
Justification for classification or non-classification
There is one study available that evaluated the in vivo dermal irritation/corrosion potential of Oleyl tripropylenetetramine in rabbits. Based on the results, it is concluded that Oleyl tripropylenetetramine should be classified as corrosive (Cat.1C) under GHS.
Corrosive to eyes is assumed for substances for which dermal corrosion has been established.
There is no information is available following exposure via inhalation. However, with a vapour pressure less than 4.7 x 10-5 Pa at 20°C, potential for inhalation of vapours is limited. Also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Consequently, despite the irritant nature of the substance, respiratory irritation is not expected, and classification STOT-SE Cat.3 for respiratory irritation is not required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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