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EC number: 204-528-4 | CAS number: 122-20-3
- 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
Endpoint summary
Administrative data
Description of key information
In the key study, TIPA caused skin irritation (with maximum scores of 4 for erythema and edema according to OECD TG 404) that was reversible after 24 hours (Huels AG, 1985). In a Schwartz-Peck Prophetic Patch test with humans, no indications of skin irritation were observed (Research Testing Laboratories, Inc (1975)). In the key study for eye irritation, TIPA was determined to be a severe irritant, resulting in effects that were not reversible within 21 days in one animal, when delivered into the eyes of small white Russian rabbits undiluted (Huels AG, 1985).
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:
- September 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Study performed according to internationally accepted testing guideline, well documented
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted May 12, 1981
- Deviations:
- no
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Substance type: pure active substance
- Physical state: white crystals
- Analytical purity: approx. 99 %
- Impurities (identity and concentrations): < 1 % Diisopropanolamine - Species:
- rabbit
- Strain:
- other: Small White Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: no data
- Weight at study initiation: 2.0 - 2.6 kg
- Housing: single housing in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K4 complete feed for rabbits, ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk Haltern, Germany
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours after patch removal
- Number of animals:
- 6 (3 male, 3 female)
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² of shaved skin of the dorsal and lateral parts of the trunk of the animals
- % coverage: not mentioned
- Type of wrap if used: on the application area a mull patch (2,5 x 2,5 cm) was placed, which was covered with a polyethylen film (6 x 6 cm). The application area was then immobilised with an elastic dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD guideline 404 - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- see table 1
- Interpretation of results:
- GHS criteria not met
Reference
Table 1: Irritant/corrosive response data for each animal at each observation time
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
60 min |
0/1/0/0/1/0 |
0/0/0/0/0/0 |
24 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
48 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
72 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0.0 |
0.0 |
Reversibility*) |
c. |
n. a. |
Average time (unit) for reversion |
60 min. |
n. a. |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
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:
- September to October 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Study performed according to internationally accepted testing guideline, well documented
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 12 May 1981
- Deviations:
- no
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name of test material: Triisopropanolamin
- Substance type: pure active substance
- Physical state: solid, white crystals
- Analytical purity: approx. 99 %
- Impurities (identity and concentrations): < 1 % diisopropanolamine - Species:
- rabbit
- Strain:
- other: Small White Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.1 - 2.4 kg
- Housing: conventional, singly in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GembH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: September 4, 1985 To: October 11, 1985 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours, and 5, 7, 10, 12, 14, 19 and 21 days after application
- Number of animals or in vitro replicates:
- 6 (3 male, 3 female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm physiological saline
- Time after start of exposure: 72 hours
SCORING SYSTEM: according to Draize (Appraisals of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin 1, Texas, 1959)
TOOL USED TO ASSESS SCORE: sodium fluorescein solution (72 hours after administration) - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #3, #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #5
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3, #4, #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 12 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #3, #4, #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritant / corrosive response data:
- The effects were not reversible within 21 days in one animal.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- TIPA was determined to be a severe irritant, resulting in effects that were not reversible within 21 days in one animal out of a group of 6.
For 5 animals, observed effects were reversible within 10 days (cornea opacity, chemosis and effects on the iris) or at least 12 days (conjunctivae score). - Executive summary:
In an acute eye irritation study according to OECD 405, six (3 female, 3 male) small white russian rabbits were treated with the undiluted test subtance. The substance was applied to the eye for an exposure of 72 hours. The untreated eye was assigned as the control. After 72 hours the eye was washed with warm physiological saline. According to the Draize score the eyes were observed and scored 1, 24, 48 and 72 hours, and 5, 7, 10, 12, 14, 19 and 21 days after application. Effects on the cornea, iris, conjunctivae and chemosis were observed in all animals. For 5 animals, the effects were reversible within 10 days (cornea opacity, chemosis and effects on the iris) or at least 12 days (conjunctivae score). The effects were not reversible in one animal after 21 days and were severe, e.g. scores up to 3 for the paramter of the cornea.
TIPA was determined to be a severe irritant, resulting in effects that were not reversible within 21 days in one animal out of a group of 6.
Reference
Table 1: Irritant/corrosive response data for each animal at each observation time
Score at time point |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
1 h |
1/1/2/1/1/1 |
0/0/0/0/0/1 |
3/3/3/3/3/3 |
2/1/2/1/2/2 |
24 h |
1/1/1/1/2/1 |
1/1/1/0/1/1 |
3/3/3/3/3/3 |
1/1/1/1/1/1 |
48 h |
1/2/1/1/2/1 |
0/1/1/0/1/1 |
3/3/3/3/3/3 |
1/1/1/1/1/1 |
72 h |
1/1/1/1/2/1 |
1/0/1/0/0/1 |
3/3/3/3/3/3 |
1/0/1/1/1/1 |
5 days | 1/0/2/1/2/2 | 0/0/1/1/1/1 | 3/3/3/3/3/3 | 0/0/1/1/1/1 |
7 days | 0/0/1/2/2/2 | 0/0/1/1/1/1 | 3/1/3/3/3/3 | 0/0/0/1/0/1 |
10 days | 0/0/0/0/0/3 | 0/0/0/0/0/1 | 2/1/1/1/1/3 | 0/0/0/0/0/1 |
12 days | 0/0/0/0/0/3 | 0/0/0/0/0/1 | 0/0/0/0/0/3 | 0/0/0/0/0/1 |
14 days | 0/0/0/0/0/3 | 0/0/0/0/0/1 | 0/0/0/0/0/3 | 0/0/0/0/0/1 |
19 days | 0/0/0/0/0/3 | 0/0/0/0/0/1 | 0/0/0/0/0/2 | 0/0/0/0/0/1 |
21 days | 0/0/0/0/0/3 | 0/0/0/0/0/1 | 0/0/0/0/0/2 | 0/0/0/0/0/1 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Additional information
Skin Irritation
In the key study, TIPA was applied to the shaved skin on the dorsal and lateral portion of the trunk of small white Russian rabbits under semiocclusive conditions for 4 hours. Rabbits were observed for 14 days after exposure. TIPA caused minimal irritation, that was reversible after 24 hours. The mean erythema score and edema score were both 0 for the 24 -72 h time point (Huels AG, 1985). In another study, TIPA was administered to the abdomen of New Zealand white rabbits for several applications resulting in continuous contact with intact skin (either unoccluded or under cotton gauze); moderate redness, very slight swelling, slight exfoliation and a superficial burn developed (Dow, 1980).
These findings are supported by another study where skin irritation was investigated in Vienna White rabbits, which were exposed to TIPA for up to 20 hours under occlusive conditions, in a study performed according to a BASF internal method. Slight irritation was only observed (average erythema score of 1.5) after 20 hours of exposure, which was fully reversible within 6 days in all but one animal. Thus, TIPA was judged to be only slightly irritating to the skin (BASF, 1966). No erythema and edema were noted after 1, 5 and 15 minutes exposure.
In a Schwartz-Peck Prophetic Patch test with humans, no indications of skin irritation were observed (Research Testing Laboratories, Inc (1975), IUCLID section 7.10.4).
Eye Irritation
In the key study for eye irritation, TIPA was determined to be a severe irritant, resulting in effects that were not reversible within 21 days in one animal, when delivered into the eyes of small white Russian rabbits undiluted (Huels AG, 1985).
In a supporting study performed according to a BASF internal method, TIPA was applied to the eyes of 2 Vienna White rabbits. Eye irritation was investigated up to 8 days following exposure. Application caused slight opacity, slight to moderate erythema and chemosis and in one animal cilliar injections. Erythema, chemosis and iritis symptoms were reversible by the end of the observation period, but one animal still showed opacity. TIPA was judged as being irritating to the eyes (BASF, 1966).
Respiratory Irritation
In a study on respiratory irritation, mice were exposed to aerosol concentrations of 329 to 1070 mg/m3 TIPA (Detwiler-Okabayashi, 1996). The 3-hour exposure caused sensory (immediate onset) and pulmonary irritation (delayed onset). No mortality was observed. Post-exposure recovery of the breathing frequency was moderate to good. The RD50 (concentration capable of evoking a 50% decrease in mean breathing frequency; -/+ 95% CI) was calculated to be 815 (570 - 1069) mg/m3.
Justification for classification or non-classification
Based on the available data, TIPA does not need to be classified as irritating to the skin according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Based on the findings TIPA needs to be classified as Eye Dam. 1, H318: Causes serious eye damage in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008
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