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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
Endpoint summary
Administrative data
Description of key information
Skin irritation
Not irritating to skin, OECD TG 404, in vivo, rabbit, RL1; GLP (4 h semiocclusive, intact skin; no signs of irritationd)
Eye irritation
Not irritating to eye, OECD TG 405, in vivo, rabbit, RL1; GLP (slight to moderate ocular reactions, fully reversible within 21 d; not irritating to eyes)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-01-29 to 2002-02-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: unchanged, moistened in 0.3 mL deionized water
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution):0.5 g fully saturated TEA-EQ, hardened moistened in 0.3 mL deionized water
- Duration of treatment / exposure:
- the 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
- Number of animals:
- 3 animals
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: the substance was evenly distributed over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster, the plaster was fixed to the skin area and then covered with a semi-occlusive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm tap water
- Time after start of exposure:after the exposure period
SCORING SYSTEM: according to Draize - Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No signs of irrtations were observed during the study.
- Other effects:
- No clinical signs of systemic toxicity were observed.
- Interpretation of results:
- GHS criteria not met
- 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.
No classification for skin irritation is justified for fully saturated TEA-Esterquat according to CLP, EU GHS (Regulation (EC) No 1272/2008). - 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 g of the “fully saturated TEA-Esterquat” for 4 hours to approximately 6 cm² of body surface area. Animals then were observed for 72 hours. Irritation was scored by the method of Draize as stipulated by OECD Guideline 404.
No signs of irritation occurred during the whole observation period. No clinical signs of systemic toxicity were observed.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- 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)
- Species:
- rabbit
- Strain:
- New Zealand White
- 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. - 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.
- 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.
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
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 g of fully saturated TEA-Esterquat for 4 hours to approximately 6 cm² of body surface area. Animals then were observed for 72 hours. Irritation was scored by the method of Draize as stipulated by OECD Guideline 404.
No signs of irritation occurred during the whole observation period. No clinical signs of systemic toxicity were observed.
Eye irritation
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.
Respiratory irritation
No data on the respiratory irritation of partially unsaturated TEA-Esterquat are available.
There are no data gaps for the endpoint irritation/corrosion. No human information is available for this endpoint. However, there is no reason to believe that these results would not be applicable to humans.
Similar results were obtained with the source substance MDEA-Esterquat C16-18 and C18 unsatd.: The substance is not classified for skin or eye irritation. These data are included into the dossier to demonstrate, that both substances have a similar toxicological profile.
Justification for classification or non-classification
Based on the available data, the substance does not need to be classified for skin and eye irritation according to regulation (EC) 1272/2008. Thus, no labelling is required.
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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