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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
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- Stability: thermal, sunlight, metals
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- Additional physico-chemical information
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- 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
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- Sediment toxicity
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data
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Eye irritation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 12 May 1981
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,1',1''-nitrilotripropan-2-ol
- EC Number:
- 204-528-4
- EC Name:
- 1,1',1''-nitrilotripropan-2-ol
- Cas Number:
- 122-20-3
- Molecular formula:
- C9H21NO3
- IUPAC Name:
- 1-[bis(2-hydroxypropyl)amino]propan-2-ol
- Test material form:
- solid
Constituent 1
- 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
Test animals / tissue source
- 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
Test system
- 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)
Results and discussion
In vivo
Resultsopen allclose all
- 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.
Any other information on results incl. tables
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 |
Applicant's summary and conclusion
- 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.
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