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EC number: 931-745-8 | CAS number: 1335203-21-8
- 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:
- 2001-06-07 to 2001-06-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Guideline 11 Nousan No. 6283 (October 1, 1999); First Revision: 12 Nousan 8628 (December 6, 2000)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- oleic-acid based IQAC, DMS quaternised
- IUPAC Name:
- oleic-acid based IQAC, DMS quaternised
- Reference substance name:
- Imidazolium compounds, 2-C17-unsatd.-alkyl-1-(2-C18-unsatd. amidoethyl)-4,5-dihydro-N-methyl, Me sulfates
- EC Number:
- 931-745-8
- Cas Number:
- 1335203-21-8
- Molecular formula:
- Molecular formula cannot be given as substance is a mixture.
- IUPAC Name:
- Imidazolium compounds, 2-C17-unsatd.-alkyl-1-(2-C18-unsatd. amidoethyl)-4,5-dihydro-N-methyl, Me sulfates
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 3329 to 3867 grams
- Housing: individual housing in suspended wire mesh cages
- Diet: 150 g/day, standard laboratory rabbit diet PMI Nutrition International, Inc. Certified Rabbit LabDiet® 5322
- Water: ad libitum, municipal water
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 66-71
- Humidity (%): 50-75
- Air changes (per hr): no data
- Photoperiod: 12 hour light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Each animal served as its one control with adjacent area of untreated skin.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- PRE-EXPERIMENTAL PROCEDURE
On the day prior to dosing, the hair was removed from the backs and flanks of the rabbits using an electric clipper.
ADMINISTRATION OF THE TEST ARTICLE
Prior to use, the original container of the test article was agitated to insure a homogeneous mixture. A sufficient amount of test article was dispensed into a labeled storage vessel and a stir bar was added. The test article was stirred continuously throughout the dosing procedure. Each 0.5-ml was applied to an area of skin approximately 2.5 x 2.5 cm under a two-ply gauze patch secured in place with Micropore™ tape. The patches were overwrapped with a gauze binder and secured with Dermiform® tape. Plastic restraint collars were applied to the animals to prevent ingestion of the test article and/or bandages. The application sites were observed for erythema, edema and other dermal findings approximately 30-60 minutes and 24, 48 and 72 hours after patch removal and on study days 4, 7, 10 and 14.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
At the end of four hours, the collars and bandages were removed and the sites wiped with disposable paper towels moistened with deionized water.
SCORING SYSTEM: Dermal irritation was graded in accordance with the method of Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Very slight erythema (score 1) in all animals at day 14
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- CLINICAL SKIN OBSERVATIONS
- All animals were noted with moderate to severe erythema and very slight to slight edema. Focal eschar was noted for two animals on study day 7, and desquamation was noted for all animals on study days 7 through 14.
REVERSIBILITY
- Very slight erythema was still present for all animals at study termination (study day 14). - Other effects:
- TOXIC EFFECTS OTHER THAN SKIN IRRITATION
- There were no deaths during the study.
- Body weights: No remarkable body weight changes were noted during the study.
Any other information on results incl. tables
Irritant/corrosive response data for each animal at each observation time
Score at time point |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
0.5-1 hour |
3/2/2 |
1/1/1 |
24 hours |
3/3/3 |
1/2/2 |
48 hours |
3/3/3 |
1/1/2 |
72 hours |
3/3/3 |
1/1/1 |
4 days |
3/3/3 |
1/1/1 |
7 days |
2d/2dg/3dg |
1/1/1 |
10 days |
2d/2d/2d |
0/0/1 |
14 days |
1d/1d/1d |
0/0/0 |
d=desquamation; g = focal eschar
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Interpretation is based on erythema/eschar 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 for oleic-acid based IQAC, DMS quaternised: erythema 3/3/3 and edema 1/1.33/1.67. Edema were fully reversible within 14 days in all animals, whereas very slight erythema (score 1) was still present in all animals at study termination (day 14).
- Executive summary:
In a primary skin irritation study according to US Guideline EPA OPPTS 870.2500 (1998), OECD Guideline 404 (1992), EU Guideline B.4 (1992) and Japanese Guideline Nousan No. 6283 (1999), revised Nousan 8628 (2000), three White New Zealand rabbits were semi-occlusive dermally exposed to 0.5 ml of oleic-acid based IQAC, DMS quaternised (according to sponsor information: 80 % of CAS No. 72749-55-4, 15 % of CAS No. 9004-96-0 (Oleic acid, ethoxylated) and 5 % of CAS No. 25322-68-3 (Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated)) for 4 hours. Animals then were observed for 14 days. Irritation was scored by the method of Draize.
The oleic-acid based IQAC, DMS quaternised induced in all animals moderate to severe erythema and very slight to slight edema. Focal eschar was noted for two animals on study day 7, and desquamation was noted for all animals on study days 7 through 14. Very slight to slight erythema was still present for all animals at study termination (study day 14). Mean scores from gradings at 24, 48 and 72 hours after removal of the test material for erythema were for all animals >/=2.3 but < 4. Edema were less severe. Inflammation persisted to the end of the observation period (14 days) in all three animals.
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