Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 951-974-7 | CAS number: -
- 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:
- 1992-06-30 to 1992-07-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
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)
- Remarks:
- The study was conducted in compliance with the following GLP Regulations: GLP in Switzerland, Procedures and Principles, March 1986; OECD Principles of GLP, Paris, France, adopted May 12, 1981 and EPA, GLP Standards, Final Rule, U.S.A., Federal Register,
Test material
- Reference substance name:
- 1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C16-18 (even numbered) and C18 unsatd., Me sulfates (salts)
- Cas Number:
- 1079184-43-2
- Molecular formula:
- n.a. (UVCB)
- IUPAC Name:
- 1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C16-18 (even numbered) and C18 unsatd., Me sulfates (salts)
- Details on test material:
- - Name of test material (as cited in study report): Diethyl ester dimethyl ammonium chloride (DEEDMAC, E-4429.01)
- Molecular formula (if other than submission substance): C42H84NO4.Cl
- Molecular weight (if other than submission substance): Not available
- Substance type: Pure active substance
- Physical state: Solid
- Analytical purity: confidential detail
- Impurities (identity and concentrations): None
- Composition of test material, percentage of components: confidential detail
- Isomers composition: Not applicable
- Purity test date: confidential detail
- Lot/batch No.: confidential detail
- Expiration date of the lot/batch: confidential detail
- Stability under test conditions: Stable under storage conditions
- Storage condition of test material: At room temperature in the dark, in the original container
- Other: None
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Chbb: NZW (SPF)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH
- Age at study initiation: 19 weeks
- Weight at study initiation: Male: 3.2 kg and Females: 3.1 - 3.3 kg
- Housing: Individually housed in stainless steel cages (size: 86 X 54 X 33 cm) equipped with feed hoppers and drinking water bottles
- Diet (e.g. ad libitum): Pelleted standard Kliba 341, Batch 70/92 rabbit maintenance diet, ad libitum
- Water (e.g. ad libitum): Community tap water from Fullinsdorf, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 lux)/ 12 hours dark, music during the light period
IN-LIFE DATES: From: 1992-06-30 To: 1992-07-05
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 gm
- Concentration (if solution): Not applicable
VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable - Duration of treatment / exposure:
- Three Chbb: NZW (SPF) rabbits were dosed with 0.5 gm of Diethyl ester dimethyl ammonium chloride (DEEDMAC, E-4429.01). The test article was applied moistened with tap water to approximately 6 cm2 of the intact skin of the clipped area. It was covered with a 3.0 cm X 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm-tap water. The skin reaction was assessed at 1, 24, 48 and 72 hours after removal of the dressing, gauze patch and test article.
- Observation period:
- 1, 24, 48 and 72 hours after removal of the dressing, gauze patch and test article.
- Number of animals:
- 3 animals (one male and two females)
- Details on study design:
- TEST SITE
- Area of exposure: Approximately 6 cm2
- % coverage: Covered with a 3.0 cm X 3.0 cm patch of surgical gauze
- Type of wrap if used: The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Skin was flushed with lukewarm-tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Erythema and escher scoring from0-4 with 0 = no erythema, 1= very slight erythema, 2 = well defined erythema, 3 = moderate to severe erythema, 4 = severe erythema to slight eschar formation.
Oedema scoring from0-4 with 0 = no oedema, 1= very slight oedema, 2 = slight oedema, 3 = moderate oedema, 4 = severe oedema.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3,
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- PDII 0.33 at 1 hour for intact skin site
PDII 0.67 at 24 hours for intact skin site
PDII 0 at 48 and 72 hours for intact skin site - Other effects:
- No corrosive effect occurred on the treated skin of any animal at each measuring interval
Any other information on results incl. tables
GHS Classification Evaluation
Animal # | Degree of erythema after...[observation time] | Degree of oedema after...[observation time] | GHS ClassificationØ 24/48/72 h>/= 2.3? | |||||||
1h | 24h | 48h | 72h | 1h | 24h | 48h | 72h | Erythema | Oedema | |
40 (M) | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | No | No |
Ø 24/48/72 h = 0.33 | Ø 24/48/72 h = 0 | |||||||||
41 (F) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | No | No |
Ø 24/48/72 h = 0 | Ø 24/48/72 h = 0 | |||||||||
42 (F) | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | No | No |
Ø 24/48/72 h = 0.33 | Ø 24/48/72 h = 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: GHS Regulation EC No 1272/2008
- Conclusions:
- MDEA-Esterquat C16-18 and C18 unsatd. is slightly irritating to the skin of rabbits. The mean grades of skin reactions at 24, 48 and 72 h reading correspond to values classified as not irritant by theDirective 67/548/EEC as well as GHS Regulation EC No 1272/2008.
- Executive summary:
In a primary dermal irritation study comparable to OECD guideline 404, 12 May 1981, three White New Zealand rabbits were dermaly exposed to 0,5 g of MDEA-Esterquat C16-18 and C18 unsatd. undiluted for 4 hours to an intact area of approximately 6 cm² covered by a semi-occlusive dressing. Animals then were observed for 3 days. Irritation was scored by the method of Draize 1; 24; 48 and 72 hours after exposure.
Very slight erythema was observed 1 h after exposure in one animal and in 2/3 animals at the 24 hour reading and was reversible within 48 hours after exposure. No oedema was observed.
The mean grades of skin reactions at 24, 48 and 72 h reading correspond to values classified as not irritant by the Directive 67/548/EEC as well as GHS Regulation EC No 1272/2008.
When applied to the skin, the test article MDEA-Esterquat C16-18 and C18 unsatd. is classified as "not irritant" in this study.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.