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EC number: 262-134-8 | CAS number: 60270-33-9
- 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:
- 2008-12-24 to 2008-12-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-[3-(dimethylamino)propyl]stearamide (C18) and N-[3-(dimethylamino)propyl]docosanamide (C22) 50:50 (w/w %)
- IUPAC Name:
- N-[3-(dimethylamino)propyl]stearamide (C18) and N-[3-(dimethylamino)propyl]docosanamide (C22) 50:50 (w/w %)
- Details on test material:
- - Name of test material:50:50 (w/w %) N-[3-(dimethylamino)propyl]stearamide (C18) and N-[3-(dimethylamino)propyl]docosanamide (C22).
- Physical state: solid
- Analytical purity: 99%
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: 16 weeks
- Weight at study initiation: 2437 g
- Housing: Individually in stainless stell cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks 4642 were provided for gnawing.
- Diet (e.g. ad libitum): pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): tap water from Füllinsdorf ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2008-12-24 To: 2008-12-31
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- eye was rinsed after 24 hours but part of the test substance remained in eye
- Observation period (in vivo):
- 48 hours
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): lavage with approximately 20 mL physiological saline
- Time after start of exposure: 24 and 48 hours
SCORING SYSTEM: Commission Directive 2001/59/EC of August 06, 2001
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: animal was killed for ethical reasons after 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: animal was killed for ethical reasons after 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: animal was killed for ethical reasons after 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: animal was killed for ethical reasons after 48 h
- Irritant / corrosive response data:
- A slight opacity of the cornea affecting the whole area was noted in the treated femael at the 24-hour reading and progressed into moderate at the 48-hour evaluation. The light reflex was absent 24 to 48 hours after test item instillation. Moderate reddening and obvious swelling (chemiosis) of the conjunctivae were noted 1 hour after treatment which progressed into marked reddening and marked swelling at the 24- and 48-hour reading. The sclerae of the animal were moderately reddened at the 1-hour observation and were not assessable 24 to 48 hours after treatment due to swelling of the conjunctivae. Moderate ocular discharge was noted 1 to 48 hours after test item exposure. Blood was noted in the eye of the animal at the 48-hour evaluation.
- Other effects:
- The treated female showed uneven head and severe signs of pain during the examination of the eye at the 48-hour reading and was therefore sacrificed immediatly thereafter. The treated female showed a slight body weight loss (-0.6 %) between treatment and last observation day.
Any other information on results incl. tables
Table 1: Individual eye irritation scores of animal #1
Irritation parameter |
Time point |
Score |
Corneal opacity |
1 hour |
0 |
Area of corneal opacity |
1 hour |
0 |
Iris score |
1 hour |
0 |
Conjunctivae score |
1 hour |
2 |
Chemosis score |
1 hour |
2 |
Sclera |
1 hour |
2 |
Corneal opacity |
24 hour |
2 |
Area of corneal opacity |
24 hour |
4 |
Iris score |
24 hour |
2 |
Conjunctivae score |
24 hour |
3 |
Chemosis score |
24 hour |
4 |
Corneal opacity |
48 hour |
3 |
Area of corneal opacity |
48 hour |
4 |
Iris score |
48 hour |
2 |
Conjunctivae score |
48 hour |
3 |
Chemosis score |
48 hour |
4 |
No staining produced by the test item of the treated eye was observed. White test item remnants were evident in eye or conjuncitval sac of the animal 1 -48 hours after treatment. No corrosion of the cornea was observed at any of the reading times.
The mean score for corneal opacity, iris, redness and chemiosis of the conjunctivae were not calculated because the animal was sacrificed for ethical reasons after the 48 -hour reading.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In this in vivo eye irritation test N-[3-(dimethylamino)propyl]stearamide (C18) and N-[3-(dimethylamino)propyl]docosanamide (C22) 50:50 (w/w %) produced irreversible effects to the eye and thus has to be classified as Category 1 (irreversible effects on eye) based on CLP, EU GHS (Regulation (EC) No 1272/2008).
- Executive summary:
In a primary eye irritation study according to OECD 405, 0.1 g of N-[3-(dimethylamino)propyl]stearamide (C18) and N-[3-(dimethylamino)propyl]docosanamide (C22) 50:50 (w/w %) (99 %) was instilled into the conjunctival sac of the left eye of one young adult female New Zealand White rabbit for 48 hours. The animal then was observed for 48 hours. The eye was washed with physiological saline at 24 and 48 hours. Irritation was scored by the method of Commission Directive 2001/59/EC of August 06, 2001.
A slight opacity of the cornea affecting the whole area was noted in the treated femael at the 24-hour reading and progressed into moderate at the 48-hour evaluation. The light reflex was absent 24 to 48 hours after test item instillation. Moderate reddening and obvious swelling (chemiosis) of the conjunctivae were noted 1 hour after treatment which progressed into marked reddening and marked swelling at the 24- and 48-hour reading. The sclerae of the animal were moderately reddened at the 1-hour observation and were not assessable 24 to 48 hours after treatment due to swelling of the conjunctivae. Moderate ocular discharge was noted 1 to 48 hours after test item exposure. Blood was noted in the eye of the animal at the 48-hour evaluation. The treated female showed uneven head and severe signs of pain during the examination of the eye at the 48-hour reading and was therefore sacrificed immediatly thereafter.
In this in vivo eye irritation test N-[3-(dimethylamino)propyl]stearamide (C18) and N-[3-(dimethylamino)propyl]docosanamide (C22) 50:50 (w/w %) is classified as Category 1 (irreversible effects on eye) based on CLP, EU GHS (Regulation (EC) No 1272/2008).
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