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EC number: 614-637-2 | CAS number: 68603-75-8
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980-10-20 to 1980-10-23
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Méthode officielle d'analyse des cosmétiques et des produits de beauté (Journal Officel de la République Française du 5 Avril 1971).
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-({3-[(2-hydroxypropyl)[(9E)-octadec-9-en-1-yl]amino]propyl}amino)propan-2-ol; 1-({3-[(2-hydroxypropyl)amino]propyl}(octadecyl)amino)propan-2-ol; 1-({3-[hexadecyl(2-hydroxypropyl)amino]propyl}amino)propan-2-ol
- EC Number:
- 614-637-2
- Cas Number:
- 68603-75-8
- Molecular formula:
- R-N(CH2CHOHCH3)xCH2CH2CH2N(CH2CHOHCH3)y with x+y=3 and where R = alkyl
- IUPAC Name:
- 1-({3-[(2-hydroxypropyl)[(9E)-octadec-9-en-1-yl]amino]propyl}amino)propan-2-ol; 1-({3-[(2-hydroxypropyl)amino]propyl}(octadecyl)amino)propan-2-ol; 1-({3-[hexadecyl(2-hydroxypropyl)amino]propyl}amino)propan-2-ol
- Details on test material:
- - Name of test material (as cited in study report): DINORAM SL
- Physical state: dark brown liquid
- Lot/batch No.: 2852
No other data available
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Centre d'elevage Charles River France, 76410 Saint Aubin les Elbeuf
- Age at study initiation: not reported
- Weight at study initiation: Male : 2-2.5 kg
- Housing: The rabbits were individuall y housed in polystyrene cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 60 ± 20 %
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left untreated eye in each animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- one instillation in conjunctival sac of right eye on day 0
- Observation period (in vivo):
- 2 days (on day 3 euthanasia due to the extremely severe ocular reactions)
- Number of animals or in vitro replicates:
- 6 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: cf free text of materials and methods. Grading scale used is equivalent to the one used in OECD 405.
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- : 6 animals
- Time point:
- other: 24 and 48 hours
- Score:
- 4
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- : 6 animals
- Time point:
- other: 24 and 48 hours
- Score:
- 3
- Max. score:
- 3
- Irritant / corrosive response data:
- No deaths occured during the study.
- 24h after instillation, a grade 4 chemosis was observed in all animals. Such a chemosis (eyes closed because of swollen lids) prevented from examinating iris and cornea. A grade 3 conjunctival redness and a grade 3 discharge were also noted in all animals. Furthermore, withish secretions were noted around lids.
- 48 h after instillation, no changes from the previous description were noted.
Since eyes of all rabbits were destroyed on day 3, it was decided to stop the study and kill them for humane reasons.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: other:
- Conclusions:
- Under the experimental conditions of this study, the substance must be considered as corrosive for eyes and warrants a classification in category 1 , eye damage according to CLP regulation (Reg 1272/2008/EC) and a classification severely irritating for eyes Xi, R41 according to the directive 67/ 548/ EEC.
- Executive summary:
The potential of the test substance to induce eye irritation was assessed in 6 rabbits according to a method similar to OECD 405 guideline in compliance with Good laboratory practices.
A single dose of 0.1ml of the test item was instilled into one eye, the other eye was not treated and served as control. The eyes were not rinsed after administration of the test item. Ocular reactions were observed 24 and 48 hours after the administration.
24hours after instillation, a grade 4 chemosis was observed in all animals. Such a chemosis (eyes closed because of swollen lids) prevented from examinating iris and cornea. A grade 3 conjunctival redness and a grade 3 discharge were also noted in all animals. Furthermore, withish secretions were noted around lids. 48 hours after instillation, no changes from the previous description were noted.
Since eyes of all rabbits were destroyed on day 3, it was decided to stop the study and kill them for humane reasons.
Under these experimental conditions, the test substance was considered corrosive when administered by ocular route to rabbits.
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