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EC number: 947-853-3 | 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:
- 1984-02-02 to 1984-03-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: HLD Versuchsplan P 2/152, Revision 5, regulations of US Food and Drug Administration (Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, 1959), den FDA Good Laboratory Practice Regulations
- Version / remarks:
- 1959
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Richtlinien fiir Hautverträglichkeitsprüfungen am Kaninchen (Januar 1981) der US lnteragency Regulatory Liaison Group (IRLG)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Imidazolium compounds, 2-(C15 and C17)-1-[2-(C16 and C18) amidoethyl]-4,5-dihydro, Me sulfates
- Molecular formula:
- Molecular formula cannot be given as substance is a mixture.
- IUPAC Name:
- Imidazolium compounds, 2-(C15 and C17)-1-[2-(C16 and C18) amidoethyl]-4,5-dihydro, Me sulfates
- Reference substance name:
- Imidazolium compounds, 2-(C15 and C17 -alkyl)-1-[2-(C16 and C18) amidoethyl]-4,5-dihydro-(1 or 3)-methyl, Me sulfates
- Molecular formula:
- Molecular formula cannot be given as substance is a mixture.
- IUPAC Name:
- Imidazolium compounds, 2-(C15 and C17 -alkyl)-1-[2-(C16 and C18) amidoethyl]-4,5-dihydro-(1 or 3)-methyl, Me sulfates
- Reference substance name:
- N,N,N-trimethyl-2-[2-(C15 and C17)]-4,5-dihydro-1H-imidazol-1-yl)ethanaminium, Me sulfates
- Molecular formula:
- Molecular formula cannot be given as substance is a mixture.
- IUPAC Name:
- N,N,N-trimethyl-2-[2-(C15 and C17)]-4,5-dihydro-1H-imidazol-1-yl)ethanaminium, Me sulfates
- Reference substance name:
- Glycerol
- EC Number:
- 200-289-5
- EC Name:
- Glycerol
- Cas Number:
- 56-81-5
- Molecular formula:
- C3H8O3
- IUPAC Name:
- glycerol
- Reference substance name:
- Glycerides, C16-18 mono-
- EC Number:
- 293-208-8
- EC Name:
- Glycerides, C16-18 mono-
- Cas Number:
- 91052-47-0
- Molecular formula:
- C19H38O4 to C21H42O4
- IUPAC Name:
- Glycerides, C16-18 mono-
- Test material form:
- other: yellowish paste
Constituent 1
Constituent 2
Constituent 3
1
2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Züchter H. Fortkamp, 4540 Lengerich
- Age at study initiation: 11-17 weeks
- Weight at study initiation: 1.90 - 2.80 kg
- Housing: individually in Steel cages with perforated metal floors over trays with bedding
- Diet (e.g. ad libitum): ad libitum, SSniff K, Alleindiät für Kanninchen, Ssniff Versuchstier-Diäten GmbH, 4770 Soest
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h, with reading intervals of 24 h and 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Gauze covered with a self-adhesive, impermeable dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: After 24 h the substance was removed with disposable wipes.
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 24 and 72 h
SCORING SYSTEM:
- Method of calculation: Draize, J. H., (1959), Association of Food and Drug Officials of the US, Austin, Texas, "The Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics"
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- only two timepoints measured
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- only two timepoints measured
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- only two timpoints measured
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- only two timepoints measured
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- only two timepoints measured
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- only two timepoints measured
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- only two timepoints measured
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- only two timepoints measured
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- only two timepoints measured
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- only two timepoints measured
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- only two timepoints measured
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- only two timepoints measured
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other:
- Remarks:
- only two timepoints measured
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other:
- Remarks:
- only two timepoints measured
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other:
- Remarks:
- only two timepoints measured
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other:
- Remarks:
- only two timepoints measured
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other:
- Remarks:
- only two time points measured
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other:
- Remarks:
- only two timepoints measured
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no indication for irritation
- Remarks on result:
- no indication of irritation
- Remarks:
- only two timepoints measured
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no indication for irritation
- Remarks on result:
- no indication of irritation
- Remarks:
- only two timepoints measured
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no indication for irritation
- Remarks on result:
- no indication of irritation
- Remarks:
- only two timepoints measured
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no indication for irritation
- Remarks on result:
- no indication of irritation
- Remarks:
- only two timepoints measured
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no indication for irritation
- Remarks on result:
- no indication of irritation
- Remarks:
- only two timepoints measured
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no indication for irritation
- Remarks on result:
- no indication of irritation
- Remarks:
- only two timepoints measured
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
24 h |
2/2/2/2/2/2 |
1/1/1/1/1/1 |
72 h |
2/2/2/2/2/2 |
0/0/0/0/0/0 |
Average 24h, 72h |
2/2/2/2/2/2 |
0.5/0.5/0.5/0.5/0.5/0.5 |
Reversibility*) |
n.c. |
c. |
Average time (h) for reversion |
n.d. |
72 h |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible, n.d. = not determined
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- In the present test 6 New Zealand rabbits were dermally exposed to 0.5 g of the test item for 24h under occclusive conditions. All animals showed moderate erythema up to 72h after patch removal. Edema formation was observed in all six animals but was fully reversible within 72h. Based on these results the substance needs to be classified as Category 2 - irritant according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
- Executive summary:
In a primary dermal irritation study according to HLD Versuchsplan P 2/152, Revision 5, regulations of US Food and Drug Administration (Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, 1959), den FDA Good Laboratory Practice Regulations) and Richtlinien für Hautverträglichkeitsprüfungen am Kaninchen (Januar 1981) der US lnteragency Regulatory Liaison Group (IRLG),6 young adult New Zealand rabbitswere dermally exposed to 0.5 gofhydrogenated tallow/nortallow based IQACfor24hours under occlusive conditions. Animals then were observed for72 hours. Irritation was scored by the method of(Draize, JH, (1959)).
All animals showed moderate erythema up to 72h after patch removal. Edema formation was observed in all six animals but was fully reversible within 72h.In this study,hydrogenated tallow/nortallow based IQAC isa dermal irritant. Based on these results the substance needs to be classified as Category 2 - irritant according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
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.