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EC number: 231-609-1 | CAS number: 7651-02-7
- 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:
- weight of evidence
- Study period:
- 2012-09-13 to 2012-09-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 April 2002
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-[3-(dimethylamino)propyl]stearamide
- EC Number:
- 231-609-1
- EC Name:
- N-[3-(dimethylamino)propyl]stearamide
- Cas Number:
- 7651-02-7
- Molecular formula:
- C23H48N2O
- IUPAC Name:
- N-[3-(dimethylamino)propyl]octadecanamide
- Test material form:
- solid: pellets
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 11-13 weeks
- Weight at study initiation: 2.88 kg
- Housing: individually
- Diet (e.g. ad libitum): pelleted rabbit diet, app. 100 g/day, hay + wooden sticks
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24°C
- Humidity (%): 40-70%
- Air changes (per hr):app. 15/h
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated contralateral eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 53.6 mg (approximately 0.1 mL) - Duration of treatment / exposure:
- eyes were not rindes after treatment
- Observation period (in vivo):
- 24 h
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
SCORING SYSTEM: Draine (OECD Guideline 405)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: ca 27 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- other: no further observation due to severity of effects
- Remarks on result:
- other: Animal sacrificed and eye scored following the 24 hours observation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: ca 27 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no further observation due to severity of effects
- Remarks on result:
- other: Animal sacrificed and eye scored following the 24 hours observation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: ca. 27 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- other: no further observation due to severity of effects
- Remarks on result:
- other: Animal sacrificed and eye scored following the 24 hours observation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- other: no furtehr observation due to severity of effects
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: no further observation due to severity of effects
- Irritant / corrosive response data:
- Instillation of 53.6 mg of the test substance into an eye of one rabbit resulted in severe effects on the eyes, necessitating intermediate sacrifice of the animal for ethical reasons approximately 27 hours after dosing. The eye lesions consisted of an injury of the cornea (opacity maximum grade 2), iridial irritation grade 1 and severe effects on the conjunctivae (grey/white coloration indicating necrosis, redness, chemosis and bloody discharge). Fluorescein examination could not be performed due to the bloody discharge. Scoring of the cornea, iris and eyelids was not possible in vivo 24 hours after instillation due swelling and exudation. Due to the severity of effects in this animal, no further animals were treated.
- Other effects:
- No remnants were noted one and 24 hours after instillation. White remnants of the test substance were found ex vivo in the conjunctival sac of the eye following sacrifice, 27 hours after instillation.
No symptoms of systemic toxicity were observed in the animal during the test period.
Any other information on results incl. tables
|
1 h |
24 h |
Ex vivo (Animal sacrificed and eye scored following the 24 hours observation) |
Cornea, opacity |
0 |
n.a. |
2 |
Iris |
1 |
n.a. |
0 |
Conjunctival redness |
2 |
3 |
3 |
Chemosis |
4 |
4 |
n.a. |
Conjunctival discharge |
2 |
3 |
n.a. |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In this study, Stearic acid 3-(dimethylaminopropyl)amide has irreversible effects on the eyes (Category 1).
- Executive summary:
In a primary eye irritation study according to OECD guideline 405, adopted 24 April 2002 and EU method B.5, May 2008, 53.6 mg (approximately 0.1 mL) of Stearic acid 3-(dimethylaminopropyl)amide was instilled into the conjunctival sac of an eye of a male young adult New Zealand White rabbit. The eye was not rinsed after application. The animal was observed for 24 h. Irritation was scored by the method of Draize.
Instillation of the test substance into the eye resulted in severe effects on the eyes, necessitating intermediate sacrifice of the animal for ethical reasons approximately 27 hours after dosing.
The eye lesions consisted of an injury of the cornea (opacity maximum grade 2), iridial irritation grade 1 and severe effects on the conjunctivae (grey/white coloration indicating necrosis, redness, chemosis and bloody discharge).
Fluorescein examination could not be performed due to the bloody discharge. Scoring of the cornea, iris and eyelids was not possible in vivo 24 hours after instillation due to swelling and exudation. Due to the severity of effects in this animal, no further animals were treated.
In this study, Stearic acid 3-(dimethylaminopropyl)amide has irreversible effects on the eyes (Category 1).
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