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EC number: 931-209-3 | CAS number: 1337540-53-0
- 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:
- 2010-05-04 to 2010-05-25
- 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), reaction products with triethanolamine, di-Me sulfate-quaternized
- Cas Number:
- 91032-11-0
- Molecular formula:
- n.a. (UVCB)
- IUPAC Name:
- Fatty acids, C16-18(even numbered), 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:
- other: The left eye remained untreated and served as a control.
- Amount / concentration applied:
- 0.1 g test substance.
As the test substance is a solid it was crushed with a spatula to obtain small pieces and was furthermore finely ground in a mortar. The resulting fine white powder was then applied as such. - Duration of treatment / exposure:
- 1 hour after treatment the treated eye was rinsed with 0.9 % saline solution to remove remaining test substance from the eye.
- Observation period (in vivo):
- 1 hour and 24, 48, 72 hours and 7, 14 and 21 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:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 0.9 % % saline solution
- Time after start of exposure: 1 hour after exposure
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 #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2, #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- All 3 animals showed moderate ocular reaction 1 h after application of the test substance. 24 h after application slight to moderate ocular reactions
were observed in two animals while the third animal showed still strong ocular irritation. Only in this animal distinct cornea damage was observed
24 h after application. The cornea damage declined with time and was not further observed on day 21 after treatment. Slight irritation of the
conjunctivae persists until day 7 or day 14 after treatment but 21 days after application all three animals were without any sign of ocular irritation. - Other effects:
- No symptoms of systemic toxicity were observed during the whole study.
Any other information on results incl. tables
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 |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0 |
0/0/0 |
2/2/2 |
3/2/2 |
24 h |
3/0/0 |
1/1/0 |
2/2/1 |
4/1/1 |
48 h |
3/0/0 |
1/0/0 |
2/1/1 |
3/1/1 |
72 h |
3/0/0 |
1/0/0 |
2/1/1 |
2/1/1 |
7 days |
3/0/0 |
1/0/0 |
2/1/1 |
2/1/0 |
14 days |
1/0/0 |
1/0/0 |
2/0/0 |
1/0/0 |
21 days |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
3/0/0 |
1/0.33/0 |
2/1.67/1 |
3/1/1 |
Reversibility*) |
c/c/c |
c/c/c |
c/c/c |
c/c/c |
Average time (unit) for reversion |
21 days |
21 days |
21 days |
21 days |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
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 fully saturated TEA-EQ 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 g of the fully saturated TEA-EQ was instilled into the conjunctival sac of three New Zealand White rabbits. Animals then were observed for 21 days. Irritation was scored by the method stipulated by the OECD Guideline 405.
All 3 animals showed moderate ocular reaction 1 h after application of the test substance. 24 h after application slight to moderate ocular reactions were observed in two animals while the third animal showed still strong ocular irritation. Only in this animal distinct cornea damage was observed 24 h after application. The cornea damage declined with time and was not further observed on day 21 after treatment. Slight irritation of the conjunctivae persists until day 7 or day 14 after treatment but 21 days after application all three animals were without any sign of ocular irritation.
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