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EC number: 700-414-8 | CAS number: 23328-71-4
- 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:
- 22 August 2007 to 5 September 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection: 30 August 2005 Date of Signature: 21 November 2005
Test material
- Reference substance name:
- trimethyl[3-(octadecyloxy)propyl]azanium chloride
- EC Number:
- 700-414-8
- Cas Number:
- 23328-71-4
- Molecular formula:
- C24H52ClNO
- IUPAC Name:
- trimethyl[3-(octadecyloxy)propyl]azanium chloride
- Details on test material:
- - Name of test material (as cited in study report): 3-Octadecyloxypropyl-N,N,N-trimethylammonium chloride
- Molecular formula (if other than submission substance): Not applicable
- Molecular weight (if other than submission substance): Not applicable
- Smiles notation (if other than submission substance): Not applicable
- InChl (if other than submission substance): Not applicable
- Structural formula attached as image file (if other than submission substance): Not applicable
- Substance type: white solid
- Physical state: solid
- Analytical purity: Not reported
- Impurities (identity and concentrations): Not reported
- Composition of test material, percentage of components: Not reported
- Isomers composition: Not reported
- Purity test date: Not reported
- Lot/batch No.: Exp. I-070518
- Expiration date of the lot/batch: Not reported
- Radiochemical purity (if radiolabelling): Not applicable
- Specific activity (if radiolabelling): Not applicable
- Locations of the label (if radiolabelling): Not applicable
- Expiration date of radiochemical substance (if radiolabelling): Not applicable
- Stability under test conditions: Not reported.
- Storage condition of test material: room temperature in the dark
- Other: Not reported.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK.
- Age at study initiation: 12 to 20 weeks old.
- Weight at study initiation: In the weight range of 2.0 to 3.5 kg.
- Housing: The animals were individually housed in suspended cages. The animals were returned to their cages for the duration of the exposure period.
- Diet (e.g. ad libitum): Certified Rabbit Diet ad libitum throughout the study.
- Water (e.g. ad libitum): Mains drinking water ad libitum throughout the study.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): At least 15 changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours continuous light (06:00 to 18:00) and 12 hours darkness.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- other: distilled water to moisture the test substance.
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5g of test material was moistened with 0.5 ml of distilled water. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days (1 h, 24 h, 48 h, 72 h and 7 days).
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: back (dorsal/flank).
- Type of wrap if used: Test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours.
SCORING SYSTEM: Approximately 1 hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the grading in the test guideline. An additional observation was made on Day 7 to assess the reversibility of skin reactions. The results were interpreted under EU classification system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 66520 Male
- Time point:
- other: Mean score at 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Remarks on result:
- other: Max score observed at 24, 48 and 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal: 66521 Male
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Remarks on result:
- other: Max score observed at 24, 48 and 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal: 66522 Male
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: Max score observed at 24 hour
- Irritation parameter:
- edema score
- Basis:
- animal: 66520 Male
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal: 66521 Male
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal: 66522 Male
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- The individual scores for erythema/eschar and oedema are given in the table below.
Very slight erythema was noted at all treated skin sites one hour after patch removal and at the 24 hour observation and at two treated skin sites at the 48 and 72 hour observations.
One treated skin site appeared normal at the 48-hour observation and the remaining two treated skin sites appeared normal at the 7-day observation. - Other effects:
- Not reported.
Any other information on results incl. tables
Table Individual Skin Reactions
Skin Reaction |
Observation Time |
Individual Scores – Rabbit Number and Sex |
Total |
||
66520 Male |
66521 Male |
66522 Male |
|||
Erythema/Eschar Formation |
1 Hour |
1 |
1 |
1 |
(3 ) |
24 Hours |
1 |
1 |
1 |
3 |
|
48 Hours |
1 |
1 |
0 |
( 2 ) |
|
72 Hours |
1 |
1 |
0 |
2 |
|
7 Days |
0 |
0 |
0 |
( 0 ) |
|
Oedema Formation |
1 Hour |
0 |
0 |
0 |
( 0 ) |
24 Hours |
0 |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
0 |
( 0 ) |
|
72 Hours |
0 |
0 |
0 |
0 |
|
7 Days |
0 |
0 |
0 |
( 0 ) |
|
Sum of 24 and 72-hour Readings (S): 5 |
( ) = Total values not used for calculation of primary irritation index
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material does not meet the criteria for classification according to EU classification system (Council Directive 67/548/EEC and Regulation (EC) No 1272/2008). No corrosive effects were noted.
- Executive summary:
Introduction. The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
§ OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted)
§ Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 2004/73/EC
Initial considerations. In the absence of data suggesting that the test material was unlikely to produce severe irritation/corrosion, an ex vivo pre‑screen test, the Transcutaneous Electrical Resistance (TER) Assay, was performed. The results of the pre‑screen test indicated that the test material was considered not to be corrosive to the skin and the in vivo test was performed.
Results. A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema. One treated skin site appeared normal at the 48-hour observation and the remaining two treated skin sites appeared normal at the 7-day observation.
Conclusion. The test material does not meet the criteria for classification according to EU classification system. No corrosive effects were noted.
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