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EC number: 272-789-1 | CAS number: 68911-83-1
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 10 December 2012 to 25 December 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Well documented GLP study performed according to OECD Guideline 405, EU Method B5, EPA OPPTS 870.2400 and JMAFF guidelines (2011). The only deviation of the study guidelines is that the observation period was limited to 7 days instead of 21 days according to the guideline, however the effects were fully reversible wihtin 7 days
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Observation period limited to 7 days instead of 21 days according to the guideline, however the effects were fully reversible wihtin 7 days
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- yes
- Remarks:
- Observation period limited to 7 days instead of 21 days according to the guideline, however the effects were fully reversible wihtin 7 days
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF guidelines (2011)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, tall-oil, reaction products with formaldehyde and (Z)-N-9-octadecenyl-1,3-propanediamine
- EC Number:
- 272-789-1
- EC Name:
- Fatty acids, tall-oil, reaction products with formaldehyde and (Z)-N-9-octadecenyl-1,3-propanediamine
- Cas Number:
- 68911-83-1
- Molecular formula:
- C40H76N2O
- IUPAC Name:
- Fatty acids, tall-oil, reaction products with formaldehyde and (Z)-N-9-octadecenyl-1,3-propanediamine
- Details on test material:
- - Name of test material (as cited in study report): Reaction product of oleic acid, N1-(9Z)-9-octadecen-1-yl-1,3-propanediamine and paraformaldehyde
- Substance type: Dark brown liquid
- Physical state: Liquid
- Analytical purity: > 99%
- Composition of test material, percentage of components: 0.10% H2O
- Lot/batch No.: 8351213508
- Expiration date of the lot/batch: 05 May 2014
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
- Other: specific gravity: 0.896 at 20°C; pH: 10.7 in aqueous solution (50% extract)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L'Arbresle Cedex, France
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: at least 1.0 kg
- Housing: Animals were individually housed in labeled cages with perforated floors and shelters.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24°C
- Humidity (%): 40 to 70%
- Air changes (per hr): 15 room air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye remained untreated and served as the reference control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- The eye lids were gently held together for about one second to prevent loss of the test substance.
- Observation period (in vivo):
- Mortality/viability: twice daily
Toxicity: at least once daily
Body weight: day of treatment (prior to instillation) and after the final observation
Necropsy: no necropsy was performed according to the protocol
Irritation: The eyes of each animal were examined approximately 1, 24, 48 and 72 hours and 7 days after instillation of the test substance. The irritation scores and a description of all other (local)effects were recorded. - Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- SCORING SYSTEM:
Scoring of corneal irritation (score 0 to 4), area of cornea involved (score 0 to 4), iris (score 0 to 2), conjunctival irritation (score 0 to 3), chemosis (score 0 to 4), discharge (score 0 to 3)
TOOL USED TO ASSESS SCORE: Immediately after the 24-hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage.
Where standard lighting was considered inadequate for observing minor effects, eye examinations were performed using an ophthalmic examination lamp.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Instillation of 0.1 mL of Reaction Product of Oleic acid, N1-(9Z)-9-octadecen-1-yl-1,3-propanediamine and paraformaldehyde into one eye of each of three rabbits resulted in effects on the conjunctivae for all animals and an effect on the cornea for one animal.
The irritation of the conjunctivae consisted of redness, chemosis and discharge and completely resolved within 7 days in all animals. Mean scores of redness following grading at 24, 48 and 72 hours after instillation were 1.3 for all animals and mean scores of chemosis following grading at 24, 48 and 72 hours after instillation were 1.3 for all animals and mean scores of chemosis following grading at 24, 48 and 72 hours after instillation were 0.3 for two animals and 0.0 for the other animal.
One animal showed sight dulling of the normal luster of the cornea which resolved within 24 hours, but no corneal opacity was observed.
No iridial irritation was observed and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage.
Corrosion:
There was no evidence of ocular corrosion.
Coloration/remnants:
No staining of (peri)ocular tissues by the test substance was observed and no test substance remnants were seen. - Other effects:
- Toxicity/mortality:
No signs of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this test, reaction product of oleic acid, N1-(9Z)-9-octadecen-1-yl-1,3-propanediamine and paraformaldehyde does not have to be classified and has no obligatory labelling requirements for eye irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) and Regulation (EC) No 1272/2008 of the European Parliament and the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures including all amendments.
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