1-(dimethylamino)propan-2-ol

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The test substance did not cause gene mutations in Salmonella typhimurium (Ames test, OECD TG 471, GLP) and in Chinese hamster V79 cells (HPRT assay, OECD TG 476, GLP), nor is it considered to have chromosome-damaging or chromosome-inducing effect in Chinese hamster V79 cells (in vitro micronucleus test, OECD TG 487, GLP) in the absence and presence of metabolic activation.

Link to relevant study records

Reference

Reference 1

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

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 471 (Bacterial Reverse Mutation Assay)

Qualifier:

according to guideline

Guideline:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Specific details on test material used for the study:

- Name of test material (as cited in study report): Dimethylisopropanolamin
- Analytical purity: 98.9 %

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver S-9 mix

Test concentrations with justification for top dose:

0, 20, 100, 500, 2500, 5000 µg/plate (standard plate test)
0, 4, 20, 100, 500, 2500 µg/plate (preincubation test)

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: [water]
- Justification for choice of solvent/vehicle: Due to the good solubility of the test substance in water, water was selected as the vehicle.

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

with S-9 mix for strains TA 1535, TA 100, TA 1537, TA 98 and E.coli WP2 uvrA

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: N-methyl-N'-nitro-N-nitrosoguanidine

Remarks:

without S-9 mix for strains TA 1535 and TA 100

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenyldiamine

Remarks:

without S-9 mix for strain TA 98

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

without S-9 mix for strain TA 1537

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

N-ethyl-N-nitro-N-nitrosoguanidine

Remarks:

without S-9 mix for strain E.coli WP2 uvrA

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation); preincubation

DURATION
Plate incorcoration method:
- Exposure duration: ca. 48-72 hours at 37°C
Preincubation method:
- Preincubation period: 20 minutes at 37°C
- Exposure duration: ca. 48-72 hours at 37°C

NUMBER OF REPLICATIONS:
- 3 test plates per dose or per control

DETERMINATION OF CYTOTOXICITY
- Decrease in the number of revertants
- Reduced his- or trp- background growth
- Reduction in the titer

Evaluation criteria:

The test chemical is considered positive in this assay if a dose-related and reproducible increase in the number of revertant colonies (i.e. about doubling of the spontaneous mutation rate) in at least one tester strain is observed either without S-9 mix or after adding a metabolizing system.
A test substance is generally considered nonmutagenic in this test if the number of revertants for all tester strains were within the historical negative control range under all experimental conditions in two experiments carried out independently of each other.

Statistics:

no data

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

occasionally at concentrations of ≥ 2500 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

ADDITIONAL INFORMATION ON CYTOTOXICITY:
A weakly bacteriotoxic effect (slight decrease in the number of his+ or trp+ revertants, reduction in the titer) was occasionally observed depending on the strain and test conditions at doses ≥ 2500 µg/plate.

Reference 2

Endpoint:

in vitro cytogenicity / micronucleus study

Remarks:

Type of genotoxicity: chromosome aberration

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:

other: OECD Guideline 487 (In vitro Mammalian Cell Micronucleus Test)

GLP compliance:

yes (incl. QA statement)

Remarks:

BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany

Type of assay:

in vitro mammalian cell micronucleus test

Specific details on test material used for the study:

- Name of test material (as cited in study report): N,N-Dimethylisopropanolamine
- Test substance No.: 05/0403-2
- Physical state: Liquid, colorless, clear
- Analytical purity: 95.5 g/100 g
- Lot/batch No.: B 5470
- Storage condition of test material: Room temperature, avoid temperatures > 25°C
- Storage stability: The stability of the test substance under storage conditions throughout the study period was guaranteed until 17 May 2013 as indicated by the sponsor, and the sponsor holds this responsibility.

Species / strain / cell type:

Chinese hamster lung fibroblasts (V79)

Details on mammalian cell type (if applicable):

The V79 cell line is a permanent cell line derived from the Chinese hamster and has a
− high proliferation rate (doubling time of about 12 - 14 hours),
− high plating efficiency (≥ 90%),
− stable karyotype (modal number of 22 chromosomes).

Stocks of the V79 cell line (1-mL portions) were maintained at -196°C in liquid nitrogen using 7% (v/v) DMSO in culture medium as a cryoprotectant. Each batch used for the cytogenetic experiments was checked for
− mycoplasma contamination,
− karyotype stability,
− plating efficiency (=colony forming ability) incl. vital staining.

Metabolic activation:

with and without

Metabolic activation system:

Phenobarbital/β-naphthoflavone induced rat liver S9 mix

Test concentrations with justification for top dose:

1st experiment
34.38, 68.75, 137.50, 275.00, 550.00, 1100.00 µg/mL (4-h exposure, with and without S9 mix)

2nd experiment
51.56, 103.13, 206.25, 412.50, 825.00 µg/mL (24-h exposure, without S9 mix)
206.25, 412.50, 825.00, 1100.00 µg/mL (4-h exposure, with S9 mix)

Vehicle / solvent:

Due to the good solubility of the test substance in water, culture medium (Minimal Essential Medium: MEM) was selected as vehicle.

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

ethylmethanesulphonate

Remarks:

without metabolic activation

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

cyclophosphamide

Remarks:

with metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium

DURATION
- Exposure duration: 4 hours (experiment 1 and experiment 2 with S9 mix) or 24 hours (experiment 2 without S9 mix)
- Recovery time: At the end of the exposure period, the medium was removed and the cultures were rinsed twice with 5 mL HBSS (Hanks Balanced Salt Solution). Subsequently, 5 mL MEM (incl. 10% [v/v] FCS) was added and incubated at 37°C, 5% (v/v) CO2 and ≥ 90% humidity for 20 hours (experiment 1 and experiment 2 with S9 mix). In the case of continuous treatment (experiment 2 without S9 mix), the cell preparation was started directly at the end of exposure.
- Harvest time: 24 hours after start of exposure, the medium was completely removed. For hypotonic treatment, 5 mL of prewarmed 1.5% (w/v) Sodium citrate solution (37°C) was added for about 5 minutes. Then the hypotonic solution was removed and 5 mL cold fixative (ethanol:glacial acetic acid: formaldehyde [37% {v/v}], ratio 3:1:0.0125; +4°C) was added. After 5 minutes the fixative was removed and 5 mL of fresh cold fixative was added. Then the dishes were kept at room temperature for at least another 5 minutes for complete fixation.

STAIN (for cytogenetic assays): Wrights solution (modified May-Grünwald solution)

NUMBER OF REPLICATIONS: at least 2 cultures were evaluated per test group

NUMBER OF CELLS EVALUATED: at least 1000 cells per culture were evaluated for the occurrence of micronucleated cells

DETERMINATION OF CYTOTOXICITY
For additional information about the cytotoxic potential of the test substance cells were seeded in flasks (2.5x10^5 cells per 25 cm2 flask) about 24 – 30 hours prior to exposure. The cells were treated similar to the slides using the same media and test substance concentrations. At the end of recovery period single cell suspensions were prepared from each test group (all test groups, except the positive controls) and the cells were counted using a cell counter. Based on these data the relative increase in cell count (RICC) was calculated.

Evaluation criteria:

Acceptance criteria
The in vitro micronucleus assay is considered valid if the following criteria are met:
- The quality of the slides allowed the identification and evaluation of a sufficient number of analyzable cells.
- The number of cells containing micronuclei in the vehicle control was within the range of the historical negative control data.
- The positive control substances both with and without S9 mix induced a significant increase in the number of micronucleated cells.

Assessment criteria
A test substance is considered "positive" if the following criteria are met:
- A significant, dose-related and reproducible increase in the number of cells containing micronuclei.
- The number of micronucleated cells exceeds both the value of the concurrent vehicle control and the range of the historical negative control data.

A test substance generally is considered "negative" if the following criteria are met:
- The number of micronucleated cells in the dose groups is not significant increased above the concurrent vehicle control value and is within the range of the historical negative control data.

Statistics:

The statistical evaluation of the data was carried out using the MUVIKE program system (BASF SE). The proportion of cells containing micronuclei was calculated for each group. A comparison of each dose group with the concurrent vehicle control group was carried out using Fisher's exact test for the hypothesis of equal proportions. This test is Bonferroni-Holm corrected versus the dose groups separately for each time and was performed one-sided.

Species / strain:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

Cytotoxicity indicated by clearly reduced relative increase in cell count (RICC) was observed at the highest applied test substance concentrations after 24 hours continuous treatment in the absence of metabolic activation.

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

True negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

RANGE-FINDING/SCREENING STUDIES:
In the pretest the parameters pH value and osmolarity were not relevantly influenced by the addition of the test substance preparation to the culture medium at the concentrations measured.
However, a slight pH shift was observed at the highest required concentration prior to testing. Therefore, the pH of the stock solution was adjusted to a physiological value prior to application using small amounts of 32% (w/v) HCl.
In addition, no test substance precipitation in culture medium was observed up to the highest required concentration of 1100 μg/mL after 4 and 24 hours treatment in the absence and the presence of S9 mix.
After 4 hours treatment in the absence and the presence of S9 mix no cytotoxicity indicated by clearly reduced relative increase in cell count of below 40 - 50% was observed. In the pretest with 24 hours continuous treatment in the absence of S9 mix, the relative increase in cell count was clearly reduced after treatment with 550 μg/mL and above.

ADDITIONAL INFORMATION ON CYTOTOXICITY:
Proliferation index
The proliferation index (PI) is based on the scoring of 1000 cells per culture (2000 cells per test group) for the different test groups without and with metabolic activation and includes the measurement of colony size.
Relative increase in cell count
In the absence and the presence of S9 mix no cytotoxicity indicated by clearly reduced PI values was observed at the test groups evaluated for cytogenetic damage. In addition, in both main experiments after 4 hours treatment with the test substance in the absence and the presence of S9 mix no relevant growth inhibition indicated by reduced cell counts was observed. However, in the 2nd Experiment in the absence of S9 mix after 24 hours treatment the RICC was strongly reduced at 825 μg/mL.
Cell morphology
In the absence of metabolic activation cell attachment and/or cell morphology was adversely effected (grade > 2) from 275 μg/mL onward after 4 hours exposure in the 1st Experiment and from 412.5 μg/mL onward after 24 hours exposure in the 2nd Experiment, respectively. Besides, in both experiments in the presence of metabolic activation no adverse effects on cell attachment and/or cell morphology were observed.
Treatment conditions
Osmolarity and pH values were not influenced by test substance treatment. However, a slight pH shift was observed at the highest required concentration prior to testing. Therefore, the pH of the stock solution was adjusted to a physiological value prior to application using small amounts of 32% (w/v) HCl.
No precipitation of the test substance in culture medium was observed.

Reference 3

Endpoint:

in vitro gene mutation study in mammalian cells

Remarks:

Type of genotoxicity: gene mutation

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 476 (In Vitro Mammalian Cell Gene Mutation Test)

Qualifier:

according to guideline

Guideline:

EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test

GLP compliance:

yes (incl. QA statement)

Remarks:

Harlan Cytotest Cell Research GmbH, In den Leppsteinswiesen 19, 64380 Rossdorf, Germany

Type of assay:

in vitro mammalian cell gene mutation test using the Hprt and xprt genes

Specific details on test material used for the study:

- Name of test material (as cited in study report): N,N-Dimethylisopropanolamine
- Test item number: 05/0403-2
- Physical state: Colorless, clear, liquid
- Analytical purity: 95.5 g/100 g
- Lot/batch No.: B 5470
- Stability under test conditions: Room temperature
- Stability in Solvent: Not indicated by the sponsor

Target gene:

HPRT (hypoxanthine-guanine phosphoribosyl transferase)

Species / strain / cell type:

Chinese hamster lung fibroblasts (V79)

Details on mammalian cell type (if applicable):

Large stocks of the V79 cell line (supplied by Laboratory for Mutagenicity Testing; Technical University, 64287 Darmstadt, Germany) are stored in liquid nitrogen in the cell bank of Harlan CCR allowing the repeated use of the same cell culture batch in experiments. Before freezing, the level of spontaneous mutants was depressed by treatment with HAT-medium. Each batch is screened for mycoplasm contamination and checked for karyotype stability and spontaneous mutant frequency. Consequently, the parameters of the experiments remain similar because of the reproducible characteristics of the cells.
Thawed stock cultures are propagated at 37 °C in 80 cm2 plastic flasks. About 5x10^5 cells were seeded into each flask with 15 mL of MEM (minimal essential medium) containing Hank’s salts supplemented with 10 % foetal bovine serum (FBS), neomycin (5 μg/mL) and amphotericin B (1 %). The cells were sub-cultured twice weekly. The cell cultures were incubated at at 37 °C in a 1.5 % carbon dioxide atmosphere (98.5 % air).

Metabolic activation:

with and without

Metabolic activation system:

Phenobarbital/β-naphthoflavone induced rat liver S9 mix

Test concentrations with justification for top dose:

34.8, 68.8, 137.5, 275.0, 550.0, 1100.0 µg/mL

Vehicle / solvent:

Deionised water (local tap water, deionised at Harlan CCR). The final concentration of deionised water in the culture medium was 10 % v/v.

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

ethylmethanesulphonate

Remarks:

without metabolic activation

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

7,12-dimethylbenzanthracene

Remarks:

with metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium

DURATION
- Preincubation period: 24 hours
- Exposure duration: In the first experiment the treatment period was 4 hours with and without metabolic activation. The second experiment was performed with a treatment time of 4 hours with and 24 hours without metabolic activation.
- Expression time: After the exposure period the medium containing the test substance was replaced with complete medium following two washing steps with "saline G". Three or four days after treatment 1.5x10^6 cells per experimental point were subcultivated in 175 cm² flasks containing 30 mL medium.
- Selection time: Following the expression time of 7 days five 80 cm² cell culture flasks were seeded with about 3 - 5x10^5 cells each in medium containing 6-TG. The cultures were incubated at 37 °C in a humidified atmosphere with 1.5 % CO2 for about 7-10 days. The colonies were stained with 10 % methylene blue in 0.01 % KOH solution.
- Fixation time: 17-21 days

SELECTION AGENT: 6-thioguanine

NUMBER OF REPLICATIONS: duplicate cultures per concentration level

NUMBER OF CELLS EVALUATED: The stained colonies with more than 50 cells were counted. In doubt the colony size was checked with a preparation microscope.

DETERMINATION OF CYTOTOXICITY
- Method: Toxicity of the test item is indicated by a reduction of the cloning efficiency.

Evaluation criteria:

The gene mutation assay is considered acceptable if it meets the following criteria:
- The numbers of mutant colonies per 10^6 cells found in the solvent controls falls within the laboratory historical control data.
- The positive control substances should produce a significant increase in mutant colony frequencies.
- The cloning efficiency II (absolute value) of the solvent controls should exceed 50 %.
- The data of this study comply with the above mentioned criteria.

- A test item is classified as positive if it induces either a concentration-related increase of the mutant frequency or a reproducible and positive response at one of the test points.
- A test item producing neither a concentration-related increase of the mutant frequency nor a reproducible positive response at any of the test points is considered non-mutagenic in this system.

A positive response is described as follows:
- A test item is classified as mutagenic if it reproducibly induces a mutation frequency that is three times above the spontaneous mutation frequency at least at one of the concentrations in the experiment.
- The test item is classified as mutagenic if there is a reproducible concentration-related increase of the mutation frequency. Such evaluation may be considered also in the case that a threefold increase of the mutant frequency is not observed.

However, in a case by case evaluation this decision depends on the level of the corresponding solvent control data. If there is by chance a low spontaneous mutation rate within the laboratory's historical control data range, a concentration-related increase of the mutations within this range has to be discussed. The variability of the mutation rates of solvent controls within all experiments of this study was also taken into consideration.

Statistics:

A linear regression (least squares) was performed to assess a possible dose dependent increase of mutant frequencies. The number of mutant colonies obtained for the groups treated with the test item were compared to the solvent control groups. A trend is judged as significant whenever the p-value (probability value) is below 0.05. However, both, biological relevance and statistical significance was considered together.

Species / strain:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

solely in the second experiment without metabolic activation at 550.0 μg/mL and above

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

RANGE-FINDING/SCREENING STUDIES:
The range finding pre-experiment was performed using a concentration range of 8.6 to 1100 μg/mL to evaluate toxicity in the presence (4 hours treatment) and absence (4 hours and 24 hours treatment) of metabolic activation.
Following 4 hours treatment no cytotoxic effects indicated by a cloning efficiency below 50% were noted up to the maximum concentration with and without metabolic activation. Following continuous treatment solely performed without metabolic activation (24 hours) relevant cytotoxic effects occurred at 550.0 μg/mL and above.
The test medium was checked for precipitation or phase separation at the end of each treatment period (4 or 24 hours) prior to removal to the test item. No precipitation or phase separation occurred up to the maximum concentration with and without metabolic activation following 4 and 24 hours treatment.
Based on the results of the pre-experiment, the maximum concentration in the main experiments was again 1100 μg/mL. The concentrations were generally spaced by a factor of 2.

ADDITIONAL INFORMATION ON CYTOTOXICITY:
Relevant cytotoxic effects indicated by a relative cloning efficiency I or cell density below 50% in both parallel cultures solely occurred in the second experiment without metabolic activation at 550.0 μg/mL and above. The recommended cytotoxic range of approximately 10-20% relative cloning efficiency I or relative cell density was covered.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Dimethylisopropanolamine was tested in the Ames reverse mutation assay (GLP compliant study according to OECD guideline 471 and 472) using S. typhimurium strains TA98, TA100, TA1535 and TA1537 and E. coli strain WP2 at 20 to 5000 µg/plate in a standard plate test and 4 to 2500 µg/plate in a preincubation test, both with and without metabolic activation (BASF AG, 1999). In both tests, the test substance did not lead to an increase in the number of revertant colonies either with or without metabolic activation. In some strains, a weak bacteriotoxic effect was occasionally observed at doses ≥ 2500 µg/plate.

 

The potential of N,N-Dimethylisopropanolamine to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster was assessed in a GLP compliant study according to OECD guideline 476 (Harlan CCR, 2012).

The assay was performed in two independent experiments, using two parallel cultures each. Based on the results of an initial range-finding cytotoxicity test for the determination of the experimental doses, the doses tested were 34.8, 68.8, 137.5, 275.0, 550.0, 1100.0 µg/mL. The first experiment was performed with and without S9 mix and a treatment period of 4 hours. The second experiment was performed with a treatment time of 4 hours with, and 24 hours without metabolic activation. The test item was dissolved in deionised water.

No substantial and reproducible dose dependent increase of the mutation frequency was observed up to the maximum concentration with and without metabolic activation. Appropriate reference mutagens (EMS and DMBA), used as positive controls, induced a distinct increase in mutant colonies and thus, showed the sensitivity of the test system and the activity of the metabolic activation system.

In conclusion it can be stated that under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells.

Therefore, N,N-Dimethylisopropanolamine is considered to be non-mutagenic in this HPRT assay.

 

The potential of N,N-Dimethylisopropanolamine to induce micronuclei in Chinese hamster V79 cells in vitro (clastogenic or aneugenic activity) was assessed in a GLP compliant study according to OECD guideline 487 (BASF 2013). Two independent experiments were carried out, both with and without the addition of liver S9 mix from induced rats (exogenous metabolic activation).

According to an initial range-finding cytotoxicity test for the determination of the experimental doses, the following doses were tested in the first experiment: 0, 34.38, 68.75, 137.50, 275.00, 550.00 and 1100.00 μg/mL (4 hours exposure, 24 hours harvest time, with and without S9 mix). The doses tested in the second experiment were: 0, 51.56, 103.13, 206.25, 412.50 and 825.00 μg/mL (24 hours exposure, 24 hours harvest time, without S9 mix) and 0, 206.25, 412.50, 825.00 and 1100.00 μg/mL (4 hours exposure, 24 hours harvest time, with S9 mix).

A sample of at least 1000 cells for each culture were analyzed for micronuclei, i.e. 2000 cells for each test group.

The negative controls gave frequencies of micronucleated cells within the historical negative control data range for V79 cells. Both positive control substances, EMS and cyclophosphamide, led to the expected increase in the number of cells containing micronuclei.

Cytotoxicity indicated by clearly reduced relative increase in cell count (RICC) was observed at the highest applied test substance concentrations after 24 hours continuous treatment in the absence of metabolic activation.

On the basis of the results of the present study, the test substance did not cause any biologically relevant increase in the number of cells containing micronuclei either without S9 mix or after adding a metabolizing system in two experiments carried out independently of each other.

Thus, under the experimental conditions described, N,N-Dimethylisopropanolamine is considered not to have a chromosome-damaging (clastogenic) effect or to induce numerical chromosomal aberrations (aneugenic activity) under in vitro conditions in V79 cells in the absence and the presence of metabolic activation.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result, the substance is not considered to be classified for genotoxicity under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EC) No. 2018/1480.