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EC number: 236-291-8 | CAS number: 13282-70-7
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From : 2014-10-28 To: 2014-12-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-[3-(dimethylamino)propyl]stearamide monoacetate
- EC Number:
- 236-291-8
- EC Name:
- N-[3-(dimethylamino)propyl]stearamide monoacetate
- Cas Number:
- 13282-70-7
- Molecular formula:
- C23H48N2O.C2H4O2
- IUPAC Name:
- N-[3-(dimethylamino)propyl]stearamide monoacetate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Received from Robinson Services, Inc. Mocksville, NC on November 5 and November 12, 2014.
- Age at study initiation: Young adult (10 weeks)
- Weight at study initiation: 2383-2702 grams at experimental start.
- Housing:stainless steel caging.
- Diet (e.g. ad libitum): Harlan Teklad Global High Fiber Rabbit Diet® #2031. A designated amount of the diet was available to each rabbit (approximately 150 grams/day).
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum.
- Acclimation period:6 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 40-50%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle.
IN-LIFE DATES: From: To:
Test system
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Five-tenths of a gram of the test substance - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 30-60 minutes and 24, 48 and 72 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 3501
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 3501
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: 3502
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 3502
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: 3503
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 3503
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There was no skin irritation observed at any treated site during this study.
Any other information on results incl. tables
Individual Skin Irritation Scores
Erythema/Edema
|
|
| Time After Patch Removal | |||
Animal n. | Sex | Immediately after patch removal | 30-60 min | 24 hrs | 48 hrs | 72 hrs |
3501 | F | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 |
3502 | F | n/a | 0/0 | 0/0 | 0/0 | 0/0 |
3503 | F | n/a | 0/0 | 0/0 | 0/0 | 0/0 |
N/A – Not Applicable
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In accordance with the provisions of Directive 67/548/EEC amended by COMMISSION DIRECTIVE 2001/59/EC of 6 August 2001, Annex VI, classification is not required.
According to the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Fifth revised edition 2013 under the conditions of this study, classification is not required. - Executive summary:
A primary skin irritation test was conducted with rabbits to determine the potential for H-31339 to produce irritation after a single topical application.
At the request of the Sponsor, the study was conducted in a stepwise manner using a single patch applied initially to one rabbit for 4 hours. Five-tenths of a gram of the test substance was moistened with distilled water and applied to the skin of one healthy rabbit for 4 hours. The dose site was evaluated for dermal irritation by the method of Draize et al.1 (see Table 4) immediately after patch removal and at 30-60 minutes and 24, 48, and 72 hours after patch removal. Since there was no dermal irritation noted at the dose site of this animal, the test was completed on two additional animals, as described above, except the dose sites were not evaluated immediately after patch removal.
There was no skin irritation observed at any treated site during this study.
In accordance with the provisions of Directive 67/548/EEC amended by COMMISSION DIRECTIVE 2001/59/EC of 6 August 2001, Annex VI, classification is not required based on the results of this study.
According to the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Fifth revised edition 2013 under the conditions of this study, classification is not required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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