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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-05-13 to 1996-06-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- not specified
- Remarks:
- most probably water
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- 0.1 mL of 28 % a.i. dilution of test substance
- Duration of treatment / exposure:
- no washing
- Observation period (in vivo):
- 1, 24, 48 and 72 hours. Additional observations were carried out after 7 days to check the reversiblitlity of the observed reactions.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
SCORING SYSTEM: as outlined in the OECD guideline 405, 1987
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
In the readings at 24 and 48 hours after treatment cornea was observed, by applying a 2 % aqueous sodium fluorescein solution to test the area and
then washing the area with a 0.9 % physiological saline solution. Once surplus fluorescein had been removed, the corneal alterations were observed
with the 'lid of a transilluminator with a cobalt blue filter.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- At the 60 minute and 24 hour reading moderate conjunctival redness (score 2) and mild to moderate chemosis (score 1 and 2) was observed.
Symptoms decrease with time, scores were 0 at the 48 hour reading for chemosis and after 7 days for conjuncitva. Cornea damage and iritis was not observed at any time during the study. - Other effects:
- The behaviour and physical condition of the rabbits were normal throughout the 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 |
2/2/1 |
24 h |
0/0/0 |
0/0/0 |
2/2/2 |
1/1/1 |
48 h |
0/0/0 |
0/0/0 |
1/1/1 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
1/1/1 |
0/0/0 |
7days |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0/0/0 |
0/0/0 |
1.33/1.33/1.33 |
0.33/0.33/0.33 |
Reversibility*) |
c/c/c |
c/c/c |
c/c/c |
c/c/c |
Average time (unit) for reversion |
|
7 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
- Remarks:
- 28 % dilution of test substance
- 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 oleic acid-based TEA-Esterquat (28 % a.i. dilution) according to CLP, EU GHS
(Regulation (EC) No 1272/2008). - Executive summary:
In a primary eye irritation study according to OECD Guideline 405, 1987 0.1 mL of the oleic acid-base TEA-Estequat 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.
At the 60 minute and 24 hour reading moderate conjunctival redness (score 2) and mild to moderate chemosis (score 1 and 2) was observed in all animals. Symptoms decrease with time. Scores were zero at the 48 hour reading for chemosis and after 7 days for conjuncitva. Cornea damage and iritis was not observed at any time during the study.
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