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EC number: 931-203-0 | CAS number: 1335202-88-4
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-04-07 to 2010-04-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2008
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, C16-18(even numbered) and C18 unsatd., reaction products with triethanolamine, di-Me sulfate-quaternized
- Cas Number:
- 91995-81-2 / 157905-74-3 / 93334-15-7
- Molecular formula:
- n.a. (UVCB)
- IUPAC Name:
- Fatty acids, C16-18(even numbered) and C18 unsatd., reaction products with triethanolamine, di-Me sulfate-quaternized
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL test substance.
As the test substance is a firm solid paste it was melted in a water bath at 60 °C resulting in the formation of a smooth paste. Subsequently it was held at room temperature until it cooled down to 40 °C. Then 0.1 mL of the paste was applied by means of a syringe to the eye of one animal. - Observation period (in vivo):
- 1 hour and 24, 48, 72 hours and 7 days after application of the test substance.
- Number of animals or in vitro replicates:
- 3 animals, 1 male and 2 females
- Details on study design:
- SCORING SYSTEM: as outlined in the OECD guideline 405, 2002
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Examinations of ocular reactions were facilitated without any device. After recording the observations at 24 hours, the eyes of all rabbits were further examined with the aid of fluorescein to look for damage of the cornea.
One drop of a 0.5 % (w/v) fluorescein solution in saline was poured into both eyes and washed off with saline solution 30 seconds later. Afterwards
scoring was executed by use of an UV-light lamp. This procedure was repeated at all observation time points until cornea damage was no longer
observed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2, #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- All 3 animals showed slight to moderate ocular reaction 1 hour after application of the test substance. After 24 hours slight to moderate ocular reactions were still observed in all three animals. Slight cornea opacity was observed in one animal at the 24 hour reading. The cornea damage was no longer observed 48 hours after treatment. Slight irritation of the conjunctivae persists until 72 hours but was fully reversible 7 days after application in all three animals.
- Other effects:
- No symptoms of systemic toxicity were observed during the whole study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Classification is based on effects on the cornea, iris and conjunctiva calculated as mean scores following grading at 24, 48 and 72 hours after instillation of the test material, in consideration of reversibility.
No classification for serious eye damage/eye irritation is justified for the partially unsaturated TEA-Esterquat according to CLP, EU GHS (Regulation (EC) No 1272/2008). - Executive summary:
In a primary eye irritation study according to OECD Guideline 405, 2002 0.1 mL of the partially unsaturated TEA-Esterquat was instilled into the conjunctival sac of three New Zealand White rabbits. Animals then were observed for 7 days. Irritation was scored by the method stipulated by the OECD Guideline 405.
All three animals showed slight to moderate ocular reaction 1 h after application of the test substance. 24 h after application slight to moderate ocular reactions were still observed in all three animals. Slight cornea opacity was observed in one animal 24 h after application. The cornea damage was not further observed 48 h after treatment. Slight irritation of the conjunctivae persists until 72 h but 7 days after application all three animals were without any sign of ocular irritation.
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