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Diss Factsheets
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EC number: 931-216-1 | CAS number: 1335202-95-3
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 9-Octadecenoic acid (Z)-, reaction products with triethanolamine, di-Me sulfate-quaternized
- EC Number:
- 302-242-5
- EC Name:
- 9-Octadecenoic acid (Z)-, reaction products with triethanolamine, di-Me sulfate-quaternized
- Cas Number:
- 94095-35-9
- Molecular formula:
- n.a. (UVCB)
- IUPAC Name:
- Fatty acids, C18 unsatd., reaction products with triethanolamine, di-Me sulfate-quaternized
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- duration of treatment was 4 hours
- Observation period:
- reaction was evaluated approx. 30-60 minutes and 24, 48 and 72 hours after the end of exposure period. Additional observations after 6, 9, 13 and 14 days
- Number of animals:
- 3 animals
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: the substance was placed on 2.5 x 2.5 cm squares of hydrophyllic gauze and applied to the corresponding test area. The resulting patches were held close to the body using strips of adhesive tape. Finally, a strip of gauze was wrapped around the trunk of the animal and fixed to the body using additional adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
SCORING SYSTEM: according to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- In the readings carried out 24, 48 and 72 hours after administration all of the animals showed erythematic lesions ranging from well defined erythema (grade 2) to marked erythema (grade 3), accompanied by edematic lesions ranging from very slight edema (grade 1) to slight edema (grade 2) and
dryness of the skin.
In the readings carried out on administration days 6, 9 and 13 observed reactions were disappearing in the majority of the animals. Severe dryness of the skin and eschars in the treated areas was observed in nearly all of the animals. At the end of the treatment (day 14), only one animal presented
light eschars in the treated area.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Classification is based on erythema/eschar and oedema calculated as mean scores following grading at 24, 48 and 72 hours after removal of the test material, in consideration of reversibility.
Classification for skin irritation is justified for the oleic acid-based TEA-Esterquat according to CLP, EU GHS (Regulation (EC) No 1272/2008) and
Directive 67/548/EEC. - Executive summary:
In a primary dermal irritation study according to OECD Guideline 404 1992, three New Zealand White rabbits were semi-occlusive dermally exposed to 0.5 mL of the oleic acid-based TEA-Esterquat for 4 hours to approximately 6 cm² of body surface area. Animals then were observed for 14 days. Irritation was scored by the method of Draize as stipulated by OECD Guideline 404.
In the readings carried out 24, 48 and 72 hours after administration all of the animals showed erythematic lesions ranging from well defined erythema (grade 2 to marked erythema (grade 3), accompanied by edematic lesions ranging from very slight edema (grade 1) to slight edema (grade 2) and dryness of the skin.
Effects were reversible within the 14 day observation period. In one animal, light eschars were recorded at study termination at day 14.
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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