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EC number: 203-049-8 | CAS number: 102-71-6
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Triethanolamine is not irritating to the skin, eyes and respiratory tract.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach (Germany)
- Mean weight at study initiation: males: 2.34 kg; females 2.41 kg
- Housing: individual
- Diet: 130 g/day (Ovator Solikanin 4 mm, Muskator-Werke, Düsseldorf, Germany)
- Water: 250 ml tap water/day
- Acclimatisation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 72 hours
- Number of animals:
- 1 male and 2 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lutrol, water (1:1)
- Time after start of exposure: 4 hrs
SCORING SYSTEM: according to Draize scoring system - 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
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
Reference
Readings |
Animal |
Exposure period: 4 h |
||
Erythema |
Edema |
Additional findings |
||
4 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
|
|
3 |
0 |
0 |
|
|
24 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
|
|
3 |
0 |
0 |
|
|
48 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
|
|
3 |
0 |
0 |
|
|
72 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
|
|
3 |
0 |
0 |
|
|
Mean 24, 48, 72 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
|
|
3 |
0 |
0 |
|
|
Mean 24, 48, 72 h |
1-3 |
0 |
0 |
|
(Calculation of the mean according to 83/467/EEC criteria of July 29th, 1983)
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- BASF-Test
- GLP compliance:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: No. XXI/170 - Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Mean Weight at study initiation: 2.45 kg
- Diet: Altromin MS (Altroge, Germany) ad libitum
- Water: ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: concurrent saline
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 m³
- Concentration: concentrated - Duration of treatment / exposure:
- not applicable (substance was not washed out)
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2 (m/f)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: none
Readings at 10 min, 1 and 24 hrs, 3 and 8 days
SCORING SYSTEM: initial scoring system was converted into Draize-scores - Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1, 24 hours
- Score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: redness
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 8 days
- Score:
- 0
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: redness
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 hours, 8 days
- Score:
- 0
- Reversibility:
- fully reversible within: 8 days
- Interpretation of results:
- GHS criteria not met
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Draize Test according to Draize JH, Woodard G and Galvery HO. J. Pharmacol. Exp. Ther. 82:377, 1944. and CEPA (Corneal Epithelial Plasminogen Activator) Test
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Analytical purity: 98 %
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.01, 0.03, and 0.1 mL
- Concentration (if solution): unchanged - Duration of treatment / exposure:
- not applicable (eyes were not washed out)
- Observation period (in vivo):
- 21 day
- Number of animals or in vitro replicates:
- 6 per dose
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1, 3, 7, 14, 21 days
- Score:
- 0
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- other: 0.01 mL
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 day
- Score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: 0.03 mL
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 day
- Score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 0.1 mL
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 3, 7 days
- Score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 0.1 mL
- Interpretation of results:
- GHS criteria not met
Referenceopen allclose all
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
Additional findings |
|||
op |
ar |
red |
ch |
di |
||||
1 h |
1 |
- |
- |
- |
1 |
1 |
- |
|
2 |
- |
- |
- |
1 |
1 |
- |
|
|
24 h |
1 |
- |
- |
- |
1 |
0 |
- |
|
2 |
- |
- |
- |
1 |
0 |
- |
|
|
48 h |
1 |
|
|
|
|
|
|
|
2 |
|
|
|
|
|
|
|
|
72 h |
1 |
|
|
|
|
|
|
|
2 |
|
|
|
|
|
|
|
|
8 d |
1 |
- |
- |
- |
0 |
0 |
- |
|
2 |
- |
- |
- |
0 |
0 |
- |
|
|
Mean 24 -72 h |
1 |
|
|
|
|
|
|
|
2 |
|
|
|
|
|
|
|
|
Mean 24-72 h |
1-2 |
|
|
|
|
|
|
|
Rabit eye irritation scores and days to clear with different dose volumes
Maximum Draize score (mean ±SE) Dose (mL) |
Number of days to return to normal Dose (mL) |
||||
0.01 |
0.03 |
0.1 |
0.01 |
0.03 |
0.1 |
0 ± 0 |
1 ± 1 |
4 ± 1 |
1 |
1 |
3 |
Rabbit eye irritation scores at various times after instillation of TEA (Draize score (mean +/- SE)
Test material |
Dose volume |
Number of animals tested |
Day |
Maximum |
Median day to clear |
||||
1 |
3 |
7 |
14 |
21 |
|||||
TEA |
0.01 |
6 |
0 ± 0 |
0 ± 0 |
0 ± 0 |
0 ± 0 |
0 ± 0 |
0 ± 0 |
1 |
0.03 |
6 |
1 ± 1 |
0 ± 0 |
0 ± 0 |
0 ± 0 |
0 ± 0 |
1 ± 1 |
1 |
|
0.10 |
6 |
4 ± 1 |
2 ± 2 |
2 ± 2 |
0 ± 0 |
0 ± 0 |
6 ± 1 |
3 |
* Each value is the average ± SE for 6 animals.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
In a skin irritation test performed according to OECD guideline 404 (not GLP-compliant), three rabbits were exposed to TEA using an occlusive application for 4 hours. Erythema and edema were scored at 4, 24, 48, and 72 hours and the mean score was 0 in all animals. The test substance was not a skin irritant under the conditions of this study (BASF, 1983).Several other studies, in which rabbits were exposed for up to 20 hours, yielded similar results (BASF 1956, 1966, 1967, 1971).
In a study with 6 human volunteers, 2 cm2-patches soaked with the test material were applied for 24 hours to the upper arm, and skin irritation was scored upon patch removal and 24 hours thereafter (BASF AG, 1930). Besides slight biting and reddening in 1 subject, no irritation was observed and thus, the test substance was judged non-irritating.
In an eye irritation test equivalent to OECD guideline 405 (non GLP-compliant), 6 rabbits/dose were exposed to undiluted TEA at dose volumes of 0.01, 0.03, and 0.1 mL. The eyes were not irrigated. Eyes were examined and scored according to Draize et al. (1944) 1, 3, 7, 14, and 21 days after dosing. TEA was not an eye irritant under the conditions of this study (Griffith, 1980). The same conclusion was reached in an eye irritation test (non GLP-compliant, according to internal BASF standards), in which 50 µL of the test substance was instilled into the eyes of 2 rabbits, and irritation was scored 10 min, 1 and 24 hours and 8 days after administration (BASF AG, 1971). In addition, no eye irritation was observed in response to the application of 0.5 mL 20% TEA in water at pH 10 and pH 8 (BASF AG, 1956). Two other studies (performed according to internal BASF standards) demonstrated some mild irritation due to the application of 50 µL undiluted TEA to the rabbit eye, which was not fully reversible within 8 days in one animal (BASF AG, 1966, 1967). Overall, TEA is judged not to be irritating to the eyes.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin and eye irritation, the test item is not classified as skin or eye irritant according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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