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EC number: 293-625-5 | CAS number: 91081-22-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
- Vapour pressure
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- 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
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- 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
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- Endpoint summary
- Stability
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- 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
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- Biotransformation and kinetics
- Additional ecotoxological information
- 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
- Toxic effects on livestock and pets
- Additional toxicological data

Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted comparable to OECD guideline tested with the source substance CAS 102-71-6. Based on the structural similarities and the fact that the target substance is an adduct of the source substance, this study is considered valid for read-across.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- treatmant of animals for 13 prior to blood sampling
- Principles of method if other than guideline:
- According to standard NTP protocol
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2,2',2''-nitrilotriethanol
- EC Number:
- 203-049-8
- EC Name:
- 2,2',2''-nitrilotriethanol
- Cas Number:
- 102-71-6
- IUPAC Name:
- 2,2',2''-nitrilotriethanol
- Test material form:
- solid - liquid: suspension
- Details on test material:
- Name of test material (as cited in study report): Triethanolamine
- Physical state: clear, colorless, viscous liquid
- Analytical purity: 99%
- Impurities (identity and concentrations): <0.5% water; <.4% primary or secondary amines
- Lot/batch No.: Lot 3B-1-84
- Storage condition of test material: Neat chemical stored at room temperature; triethanolamine:acetone mixtures stored at 5°C, protected from light
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Simonsen Laboratories (Gilroy, CA)
- Age at study initiation: 6 weeks old
- Weight at study initiation: mean 23 g (males), 19 g (females)
- Housing: individually in Polycarbonate (Lab Products, Inc., Garfield, NJ), changed weekly, with bedding of Beta-Chips® hardwood chips (Northeastern Products, Inc., Warrensburg, NY), changed weekly
- Diet (e.g. ad libitum): NIH-07 open formula pelleted diet (Zeigler Brothers, Inc.,Gardners, PA), available ad libitum, changed weekly
- Water (e.g. ad libitum): Tap water (City of Columbus municipal supply) via automatic watering system (Edstrom Industries, Waterford, WI), available
ad libitum
- Acclimatization: 11 to 14 da
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4 - 23.9
- Humidity (%): 35 - 65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 30 June 1986 To:14 November 1986
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- - Vehicle(s)/solvent(s) used: Acetone
- Details on exposure:
- TEST SITE
- Area of exposure: area extending from the animal’s mid-back to the dorsal intrascapular region
- Time intervals for shavings or clipplings: clipped weekly
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): if the dose volume exceeded 320 μL, half the total volume was administered in the morning and the
remainder was administered in the afternoon
- Concentration (if solution): 0, 125, 250, 500, 1,000, or 2,000 mg/kg bw
- Constant volume or concentration used: yes
VEHICLE
- Justification for use and choice of vehicle (if other than water): Acetone is miscible with triethanolamine and because acetone rapidly evaporates.
USE OF RESTRAINERS FOR PREVENTING INGESTION: no - Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- daily, 5 days/week
- Post exposure period:
- none
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500, 1,000, 2,000, 4000 mg/kg bw
Basis:
other: nominal per unit body weight
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent no treatment
Examinations
- Tissues and cell types examined:
- Peripheral blood samples
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION
Doses were based on a 14-a nd 16-day study, where skin irritation was observed with higher doses.
DETAILS OF SLIDE PREPARATION:
Smears were immediately prepared and fixed in absolute methanol and were later stained with a chromatin-specific fluorescent dye mixture of Hoechst 33258/pyronin Y (MacGregor et al., 1983)
METHOD OF ANALYSIS:
Slides were scanned to determine the frequency of micronuclei in 2000 polychromatic erythrocytes (PCEs) and 10000 normochromatic erythrocytes (NCEs) in each animal per dose group. - Statistics:
- Log transformation of the NCE data, testing for normality by the Shapiro-Wilk test, and testing for heterogeneity of variance by Cochran’s test were performed before statistical analyses. The frequency of micronucleated cells among NCEs was analyzed by analysis of variance using the SAS GLM procedure. The NCE data for each dose group were compared with the concurrent solvent control with a Student’s t-test. The frequency of micronucleated cells among PCEs was analyzed by the Cochran-Armitage trend test, and individual dose groups were compared to the concurrent solvent control by Kastenbaum-Bowman’s binomial test.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- animals of high dose groups showed acanthosis and inflammation at the site of application were observed in both males and females at 4000 mg/kg bw per day, and liver and kidney weights were increased at that dose.
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- not examined
Any other information on results incl. tables
Results:
Sex | Sample Collection Time | Dose (g/kg) | Animal Number | Normochromatic Erythrocytes | |||
Trend P: 0.42 | |||||||
Male | 24 hour | No. Examined | Total MN Cells | Percent NCE | MN Cells | ||
per 1000 | |||||||
Vehicle Control | Acetone | 0 | 11 | 20 | 1.4 | ||
0 | 12 | 23 | 2 | ||||
0 | 13 | 29 | 2.2 | ||||
0 | 14 | 38 | 3.2 | ||||
0 | 15 | 14 | 1.1 | ||||
0 | 16 | 17 | 1.5 | ||||
0 | 17 | 20 | 1.7 | ||||
0 | 18 | 27 | 2 | ||||
0 | 19 | 15 | 1.2 | ||||
0 | 20 | 13 | 1.2 | ||||
Average ± SEM | ± | 1.75 ± 0.20 | |||||
Test Chemical | Triethanolamine | 1 | 71 | 22 | 2.2 | ||
1 | 72 | 18 | 1.8 | ||||
1 | 73 | 21 | 1.8 | ||||
1 | 74 | 21 | 1.6 | ||||
1 | 75 | 36 | 2.9 | ||||
1 | 76 | 22 | 1.6 | ||||
1 | 77 | 25 | 2.4 | ||||
1 | 78 | 21 | 1.8 | ||||
1 | 79 | 20 | 1.9 | ||||
1 | 80 | 8 | 0.8 | ||||
Average ± SEM | ± | 1.88 ± 0.17 | |||||
Pairwise P | 0.3138 | ||||||
Test Chemical | Triethanolamine | 2 | 100 | 15 | 1.2 | ||
2 | 91 | 18 | 1.5 | ||||
2 | 92 | 15 | 1.5 | ||||
2 | 93 | 18 | 1.8 | ||||
2 | 94 | 11 | 1.1 | ||||
2 | 95 | 15 | 1.2 | ||||
2 | 96 | 11 | 1 | ||||
2 | 97 | 18 | 1.6 | ||||
2 | 98 | 22 | 1.7 | ||||
2 | 99 | 14 | 1 | ||||
Average ± SEM | ± | 1.35 ± 0.10 | |||||
Pairwise P | 0.935 | ||||||
Test Chemical | Triethanolamine | 4 | 111 | 18 | 1.5 | ||
4 | 112 | 30 | 2.2 | ||||
4 | 113 | 18 | 1.7 | ||||
4 | 114 | 11 | 1 | ||||
4 | 115 | 19 | 1.7 | ||||
4 | 116 | 25 | 1.9 | ||||
4 | 117 | 14 | 1.4 | ||||
4 | 118 | 17 | 1.4 | ||||
4 | 119 | 19 | 1.7 | ||||
4 | 120 | 46 | 4.5 | ||||
Average ± SEM | ± | 1.89 ± 0.30 | |||||
Pairwise P | 0.3047 |
Sex | Sample Collection Time | Dose (g/kg) | Animal Number | Normochromatic Erythrocytes | |||
Trend P: 0.925 | |||||||
Female | 24 hour | No. Examined | Total MN Cells | Percent NCE | MN Cells | ||
per 1000 | |||||||
Vehicle Control | Acetone | 0 | 131 | 10 | 0.8 | ||
0 | 132 | 25 | 2 | ||||
0 | 133 | 10 | 1 | ||||
0 | 134 | 13 | 1.1 | ||||
0 | 135 | 11 | 0.9 | ||||
0 | 136 | 10 | 0.8 | ||||
0 | 137 | 12 | 1.1 | ||||
0 | 138 | 13 | 1.1 | ||||
0 | 139 | 12 | 1.1 | ||||
0 | 140 | 18 | 1.7 | ||||
Average ± SEM | ± | 1.16 ± 0.12 | |||||
Test Chemical | Triethanolamine | 1 | 191 | 17 | 1.5 | ||
1 | 192 | 20 | 1.5 | ||||
1 | 193 | 16 | 1.6 | ||||
1 | 194 | 12 | 1.2 | ||||
1 | 195 | 15 | 1.2 | ||||
1 | 196 | 9 | 0.9 | ||||
1 | 197 | 13 | 1 | ||||
1 | 198 | 15 | 1.1 | ||||
1 | 199 | 13 | 1.2 | ||||
1 | 200 | 10 | 0.9 | ||||
Average ± SEM | ± | 1.20 ± 0.08 | |||||
Pairwise P | 0.389 | ||||||
Test Chemical | Triethanolamine | 2 | 211 | 18 | 1.8 | ||
2 | 212 | 10 | 0.7 | ||||
2 | 213 | 9 | 0.9 | ||||
2 | 214 | 13 | 1.1 | ||||
2 | 215 | 17 | 1.2 | ||||
2 | 216 | 16 | 1.4 | ||||
2 | 217 | 8 | 0.8 | ||||
2 | 218 | 16 | 1.5 | ||||
2 | 219 | 9 | 0.7 | ||||
2 | 220 | 7 | 0.7 | ||||
Average ± SEM | ± | 1.07 ± 0.12 | |||||
Pairwise P | 0.7393 | ||||||
Test Chemical | Triethanolamine | 4 | 231 | 8 | 0.8 | ||
4 | 232 | 14 | 1.3 | ||||
4 | 233 | 11 | 1 | ||||
4 | 234 | 12 | 1 | ||||
4 | 235 | 4 | 0.4 | ||||
4 | 236 | 11 | 0.9 | ||||
4 | 237 | 21 | 1.7 | ||||
4 | 238 | 9 | 0.8 | ||||
4 | 239 | 12 | 1.1 | ||||
4 | 240 | 13 | 1.1 | ||||
Average ± SEM | ± | 1.00 ± 0.11 | |||||
Pairwise P | 0.8813 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Treatment of male and female mice with triethanolamineup to 4000 mg/kg bw/d for 13 weeks by dermal application did not result in any change in the frequency of micronuclei in their blood cells. - Executive summary:
Male and female B6C3F mice were treated dermally with triethanolamine up to 4000 mg/kg bw/d for 13 weeks. Analysis of periperhal blood cells after the application period did don reveal any change in the frequency of micronuclei when compared with untreated control animals. Thus, no in vivo mutagenicity could be shown for triethanolamine.
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