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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2009-12-10 to 2012-12-26
- 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.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 24 April 2002
- 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:
- - Chemical name: 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 18 weeks (male), 15 weeks (female)
- Weight at study initiation: 2598 g (male), 2235-2509 g (females)
- Housing: Individually in stainless steel cages equipped with feed hoppers abd drinking water bowles. Wood blocks and haysticks 4642 were provided for gnawing
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 diet for rabbits ad libitum
- Water (e.g. ad libitum): tap water from Füllinsdorf ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2009-12-10 To: 2009-12-26
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test item
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 10 days
- Number of animals:
- 1 male, 2 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: no data
- Type of wrap if used: restrainer bandage wrap around the abdomen
REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated skin was cleaned of residual test substance using lukewarm tap water after removal of dressing
- Time after start of exposure: 4 hours
SCORING SYSTEM: Commision Regulation (EC) No 440/2008, B.4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- One hour after test item exposure a very slight erythema was observed in the first treated female and in the male which progressed into a well-defined erythema at the 24-hour reading and persisted well-defined or very slight up to the 72-hour reading in both animals- A very light swelling was recorded in the first treated female 24 and 48 hours after removal of the dressing. Scaling was present on the skin of the male on day 7.
- Other effects:
- No staining produced by the test item of the treated skin was observed. No clinical signs were observed in the animals during the test period and no mortality occurred. All animals lost body weight during acclimatisation (1.2%-8.3%) but recovered until end of the study.
Any other information on results incl. tables
Table 1: INDIVIDUAL SKIN IRRITATION SCORES
Animal # |
1 (male) |
2 (female) |
3 (female) | ||||||
Time after exposure
|
Erythema |
Oedema |
comments |
Erythema |
Oedema |
comments |
Erythema | Oedema | comments |
1 hour |
1 |
0 |
- |
1 |
0 |
- |
0 | 0 | - |
24 hours |
2 |
0 |
- |
2 |
1 |
- |
0 | 0 | - |
48 hours |
2 |
0 |
- |
2 |
1 |
- |
0 | 0 | - |
72 hours |
2 |
0 |
- |
1 |
0 |
- |
0 | 0 | - |
7 days |
0 |
0 |
I |
0 |
0 |
- |
0 | 0 | - |
10 days |
0 |
0 |
- |
0 |
0 |
- |
0 | 0 | - |
Comments:
l. Scaling
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Judgment is based on erythema and edema calculated as mean scores for each animal following grading at 24, 48 and 72 hours after removal of the test material, in consideration of reversibility. The following mean scores were calculated: erythema 2.00/1.67/0.00 and edema 0.00/0.67/0.00. These effects were fully reversible within 7 days. Scaling was present on the skin of one animal on day 7.
- Executive summary:
In a primary dermal irritation study according to OECD Guideline 404, adopted 24 April 2002, and EU Method B.4, May 2008, 3 adult New Zealand white rabbits (1 male, 2 females) were dermally exposed to 0.5 g of N-[3-(dimethylamino)propyl]stearamide (C18) and N-[3-(dimethylamino)propyl]docosanamide (C22) 50:50 (w/w %) (99 % a.i., moistened with 0.5 ml water) to 6.25 cm² skin surface. Animals then were observed for 10 days.
Irritation was scored by the method of the numerical scoring system listed in the Commission Regulation (EC) No 440/2008, B.4.
One hour after test item exposure a very slight erythema was observed in the first treated female and in the male which progressed into a well-defined erythema at the 24-hour reading and persisted well-defined or very slight up to the 72-hour reading in both animals- A very light swelling was recorded in the first treated female 24 and 48 hours after removal of the dressing. Scaling was present on the skin of the male on day 7. In this study, N-[3-(dimethylamino)propyl]stearamide (C18) and N-[3-(dimethylamino)propyl]docosanamide (C22) 50:50 (w/w %) is classified as not irritating to rabbit skin according the criteria of CLP, EU GHS (Regulation (EC) No 1272/2008).
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