Reaction mass of diammonium (2R,3R)-2,3-dihydroxybutanedioate and diammonium bis[(2R,3R)-2,3-dioxidobutanedioato]diantimonate(2-)

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The test substance was tested for its mutagenic potential in vitro based on the ability to induce point mutations in selected loci of several bacterial strains in a reverse mutation assay according to OECD Guideline 471 under GLP conditions. Based on the results of this study, the test substance is not mutagenic in the reverse mutation assay in the absence and the presence of metabolic activation.

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Mar - Apr 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

21 Jul 1997

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

(from the competent authority) Landesamt für Umwelt Rheinland-Pfalz

Type of assay:

bacterial reverse mutation assay

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Batch No.of test material: 170492F01
- Expiration date of the Batch: 22 Jun 2019
- Purity: 100.0 area-% (HPLC fingerprint)
- Content:
21.4 g/100 g Test item
23.5 g/100 g (NH4)2C4H4O6
30 g/100 g Tartrate
6.7 g/100 g Ammonium
9.1 g/100 g Antimony
53.5 g/100 g Water
- Physical state, appearance: liquid, colorless to yellowish, clear

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: The stability of the test substance (aqueous solution) throughout the study period was guaranteed as indicated by the sponsor, therefore the stability of the test substance in the vehicle water was expected.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test substance was weighed and topped up with the chosen vehicle to achieve the required concentration of the stock solution. The test substance was dissolved in water (= ultrapure water). To achieve a clear solution of the test substance in the vehicle, the test substance preparation was shaken thoroughly. The further concentrations were diluted from the stock solution according to the planned doses. All test substance formulations were prepared immediately before administration.

FORM AS APPLIED IN THE TEST (if different from that of starting material): aqueous solution

Target gene:

his, trp

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:

phenobarbital and ß-naphthoflavone induced rat liver S9

Test concentrations with justification for top dose:

0; 100; 500; 1000; 2750; 5500 and 11000 µg/plate (Experiment 1 and Experiment 2, respectively)
In agreement with the recommendations of current guidelines 5 mg/plate or 5 µL/plate were generally selected as maximum test dose at least in the 1st Experiment. However, this maximum dose was tested even in the case of relatively insoluble test compounds to detect possible mutagenic impurities. Furthermore, doses > 5 mg/plate or > 5 µL/plate might also be tested in repeat experiments for further clarification / substantiation.
In this study, due to the purity of the test substance 11.0 mg/plate was used as top dose in all experiments.

Vehicle / solvent:

- Vehicle used: water
- Justification for choice of vehicle: Due to the good solubility of the test substance in water, water was used as vehicle.

Untreated negative controls:

yes

Remarks:

sterility control

Negative solvent / vehicle controls:

yes

Remarks:

vehicle control

True negative controls:

no

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

9-aminoacridine

other: 2-aminoanthracene (with S9 mix; 2.5 µg/plate dissolved in DMSO for TA 1535, TA 100, TA 1537 & TA 98; 60 µg/plate dissolved in DMSO for E.coli WP2 uvrA)

Remarks:

further positive control substances: N-methyl-N'-nitro-N-nitrosoguanidine (without S9 mix; 5 µg/plate dissolved in DMSO for TA 1535 & TA 100), 4-nitro-o-phenylenediamine (without S9 mix; 10 µg/plate dissolved in DMSO for TA 98)

Details on test system and experimental conditions:

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

DURATION
- Preincubation period: 20 min (PIT)
- Exposure duration: 48 - 72 h (SPT & PIT)

DETERMINATION OF CYTOTOXICITY
- Method: decrease in the number of revertants (factor ≤ 0.6), clearing or diminution of the background lawn (= reduced his- or trp- background growth)

Evaluation criteria:

Mutagenicity:
Individual plate counts, the mean number of revertant colonies per plate and the standard deviations were given for all dose groups as well as for the positive and negative (vehicle) controls in all experiments. In general, six doses of the test substance were tested with a maximum of 5 mg/plate, and triplicate plating was used for all test groups at least in the 1st Experiment. Dose selection and evaluation as well as the number of plates used in repeat studies or further experiments were based on the findings in the 1st Experiment.

Toxicity:
Toxicity detected by a
- decrease in the number of revertants (factor ≤ 0.6)
- clearing or diminution of the background lawn (= reduced his- or trp- background growth)
was recorded for all test groups both with and without S9 mix in all experiments and indicated in the tables. Single values with a factor ≤ 0.6 were not detected as toxicity in low dose groups.

Solubility:
If precipitation of the test material was observed, it would be recorded and indicated in the tables. As long as precipitation did not interfere with the colony scoring, 5 mg/plate was generally selected and analyzed (in cases of nontoxic compounds) as the maximum dose at least in the 1st Experiment even in the case of relatively insoluble test compounds to detect possible mutagenic impurities. Furthermore, doses > 5 mg/plate might also be tested in repeat experiments for further clarification / substantiation.

Statistics:

Acceptance criteria:
Generally, the experiment was considered valid if the following criteria were met
- The number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain.
- The sterility controls revealed no indication of bacterial contamination.
- The positive control substances both with and without S9 mix induced a distinct increase in the number of revertant colonies compatible with the range of the historical positive control data or above.
- Fresh bacterial culture containing approximately 10^9 cells per mL were used.

Assessment criteria:
The test substance was considered positive in this assay if the following criteria were met
- A dose-related and reproducible increase in the number of revertant colonies, i.e. at least doubling (bacteria strains with high spontaneous mutation rate, like TA 98, TA 100 and E.coli WP2 uvrA) or tripling (bacteria strains with low spontaneous mutation rate, like TA 1535 and TA 1537) of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
A test substance was generally considered non-mutagenic in this test if
- The number of revertants for all tester strains were within the range of the historical negative control data under all experimental conditions in at least two experiments carried out independently of each other.

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

SPT with S9 mix from 5500 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

PIT without S9 from 5500 µg/plate & with S9 from 11000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

SPT with S9 & PIT without S9 from 11000 µg/plate, respectively

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No test substance precipitation was found with and without S9 mix.

HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: see tables in any other information on results
- Negative (solvent/vehicle) historical control data: see tables in any other information on results

ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: A weak bacteriotoxic effect (slight decrease in the number of his+ revertants) was observed in the standard plate test and in the preincubation assay depending on the strain and test conditions from about 5500 µg/plate onward.

DISCUSSION
According to the results of the present study, the test substance did not lead to a relevant increase in the number of revertant colonies without S9 mix or after adding a metabolizing system in two experiments carried out independently of each other (standard plate test and preincubation assay).
Besides, the results of the negative as well as the positive controls performed in parallel corroborated the validity of this study, since the values fulfilled the acceptance criteria.
In this study with and without S9 mix, the number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain.
In addition, the positive control substances with and without S9 mix induced a significant increase in the number of revertant colonies compatible with the range of the historical positive control data.

Table 1: Decreased revertant numbers were observed at following concentrations [µg/plate]

Experiment	S9	TA 1535	TA 100	TA 1537	TA 98	E.coli
1st – SPT	Without	-	-	-	-	-
	With	5500 – 11000	-	-	11000	-
2nd – PIT	Without	-	-	5500 – 11000	11000	-
	With	-	-	11000	-	-

Table 2: Standard plate test without metabolic activation

Strain	Test group	Dose [µg/plate]	Mean revertants per plate	Standard deviation	Factor	Individual revertant colony counts
TA 1535	Water Test item           MNNG	- 100 500 1000 2750 5500 11000 5.0	8.0 8.7 9.0 9.3 9.7 7.3 9.7 5933.3	2.6 2.9 2.0 5.0 5.5 2.1 4.6 365.5	- 1.1 1.1 1.2 1.2 0.9 1.2 741.7	7, 6, 11 12, 7, 7 9, 11, 7 10, 14, 4 7, 16, 6 9, 5, 8 7, 7, 15 6024, 6245, 5531
TA 100	Water Test item           MNNG	- 100 500 1000 2750 5500 11000 5.0	118.0 126.3 141.7 127.0 143.0 125.7 115.7 4294.0	27.5 4.2 28.0 5.6 12.3 10.0 11.8 133.0	- 1.1 1.2 1.1 1.2 1.1 1.0 36.4	119, 145, 90 125, 131, 123 148, 111, 166 128, 121, 132 148, 152, 129 122, 118, 137 122, 102, 123 4160, 4296, 4426
TA 1537	Water Test item           AAC	- 100 500 1000 2750 5500 11000 100	9.0 7.3 7.3 9.7 4.7 6.3 6.3 849.0	1.0 2.5 2.1 1.5 2.1 1.2 1.5 136.0	- 0.8 0.8 1.1 0.5 0.7 0.7 94.3	9, 10, 8 5, 10, 7 5, 9, 8 8, 11, 10 4, 3, 7 7, 7, 5 6, 5, 8 692, 925, 930
TA 98	Water Test item           NOPD	- 100 500 1000 2750 5500 11000 10	20.3 20.7 14.3 19.0 24.0 21.7 13.7 1132.0	2.1 8.3 2.5 4.6 3.0 8.1 3.2 77.1	- 1.0 0.7 0.9 1.2 1.1 0.7 55.7	22, 18, 21 14, 30, 18 12, 14, 17 15, 24, 18 21, 24, 27 16, 31, 18 16, 10, 15 1192, 1159, 1045
E.coli	Water Test item           4-NQO	- 100 500 1000 2750 5500 11000 5	33.0 31.7 28.3 26.0 28.3 21.7 30.3 766.3	7.2 5.8 6.1 3.6 3.5 2.5 7.0 18.2	- 1.0 0.9 0.8 0.9 0.7 0.9 23.2	35, 39, 25 35, 35, 25 35, 27, 23 30, 23, 25 28, 25, 32 24, 22, 19 31, 37, 23 763, 786, 750

Table 3: Standard plate test with metabolic activation

Strain	Test group	Dose [µg/plate]	Mean revertants per plate	Standard deviation	Factor	Individual revertant colony counts
TA 1535	Water Test item           2-AA	- 100 500 1000 2750 5500 11000 2.5	13.7 10.3 11.0 8.7 11.0 7.7 6.7 210.7	1.5 2.5 1.0 1.5 1.0 1.5 3.1 5.7	- 0.8 0.8 0.6 0.8 0.6 0.5 15.4	15, 14, 12 13, 8, 10 12, 10, 11 9, 10, 7 10, 12, 11 9, 8, 6 10, 6, 4 206, 217, 209
TA 100	Water Test item           2-AA	- 100 500 1000 2750 5500 11000 2.5	127.0 114.3 129.0 111.3 114.3 115.3 117.0 1565.0	5.3 16.1 15.1 5.1 12.5 8.3 17.4 117.3	- 0.9 1.0 0.9 0.9 0.9 0.9 12.3	129, 131, 121 121, 96, 126 143, 131, 113 110, 117, 107 123, 100, 120 122, 106, 118 129, 97, 125 1691, 1545, 1459
TA 1537	Water Test item           2-AA	- 100 500 1000 2750 5500 11000 2.5	7.3 6.7 8.3 8.0 8.3 9.7 8.3 90.0	3.1 2.9 2.1 1.0 4.2 1.2 2.5 8.0	- 0.9 1.1 1.1 1.1 1.3 1.1 12.3	4, 10, 8 5, 10, 5 6, 10, 9 7, 8, 9 13, 5, 7 11, 9, 9 6, 11, 8 90, 98, 82
TA 98	Water Test item           2-AA	- 100 500 1000 2750 5500 11000 2.5	30.7 29.7 26.3 27.3 28.3 22.0 18.0 1033.0	6.1 7.6 6.8 11.6 1.5 2.6 7.5 91.7	- 1.0 0.9 0.9 0.9 0.7 0.6 33.7	32, 36, 24 28, 38, 23 21, 34, 24 38, 29, 15 30, 28, 27 21, 20, 25 10, 19, 25 1102, 1068, 929
E.coli	Water Test item           2-AA	- 100 500 1000 2750 5500 11000 60	24.0 28.3 27.0 27.0 30.0 30.0 26.7 92.7	1.7 4.0 1.0 5.3 1.0 5.6 4.0 1.5	- 1.2 1.1 1.1 1.3 1.3 1.1 3.9	25, 22, 25 32, 24, 29 26, 28, 27 25, 23, 33 31, 29, 30 35, 24, 31 29, 29, 22 93, 94, 91

Table 4: Preincubation test without metabolic activation

Strain	Test group	Dose [µg/plate]	Mean revertants per plate	Standard deviation	Factor	Individual revertant colony counts
TA 1535	Water Test item           MNNG	- 100 500 1000 2750 5500 11000 5.0	9.7 8.3 7.0 8.7 12.0 8.0 8.0 2417.3	4.5 2.5 2.0 3.1 3.6 2.6 1.7 309.5	- 0.9 0.7 0.9 1.2 0.8 0.8 250.1	5, 10, 14 11, 6, 8 5, 7, 9 8, 6, 12 11, 16, 9 7, 6, 11 10, 7, 7 2493, 2077, 2682
TA 100	Water Test item           MNNG	- 100 500 1000 2750 5500 11000 5.0	109.3 102.0 112.7 104.3 102.3 102.0 116.3 3483.3	10.2 15.7 4.7 11.2 14.2 16.8 7.8 252.7	- 0.9 1.0 1.0 0.9 0.9 1.1 31.9	105, 102, 121 109, 113, 84 111, 109, 118 114, 92, 107 115, 87, 105 83, 115, 108 110, 125, 114 3772, 3376, 3302
TA 1537	Water Test item           AAC	- 100 500 1000 2750 5500 11000 100	9.0 5.3 8.3 11.7 10.0 5.3 5.3 807.7	2.0 2.1 2.5 2.5 3.6 4.0 0.6 123.6	- 0.6 0.9 1.3 1.1 0.6 0.6 89.7	7, 9, 11 3, 7, 6 11, 6, 8 9, 14, 12 7, 14, 9 10, 3, 3 6, 5, 5 950, 727, 746
TA 98	Water Test item           NOPD	- 100 500 1000 2750 5500 11000 10	21.3 18.3 19.3 16.7 19.0 17.7 12.7 1234.0	6.5 5.0 6.4 4.6 1.7 7.2 3.1 113.2	- 0.9 0.9 0.8 0.9 0.8 0.6 57.8	21, 15, 28 13, 19, 23 23, 23, 12 14, 22, 14 18, 21, 18 26, 14, 13 12, 16, 10 1287, 1311, 1104
E.coli	Water Test item           4-NQO	- 100 500 1000 2750 5500 11000 5	30.0 35.3 32.7 27.3 24.7 25.7 26.3 526.3	7.0 3.2 5.8 4.6 5.0 1.5 2.3 73.0	- 1.2 1.1 0.9 0.8 0.9 0.9 17.5	30, 23, 37 39, 33, 34 26, 36, 36 22, 30, 30 24, 20, 30 27, 24, 26 25, 29, 25 569, 568, 442

Table 5: Preincubation test with metabolic activation

Strain	Test group	Dose [µg/plate]	Mean revertants per plate	Standard deviation	Factor	Individual revertant colony counts
TA 1535	Water Test item           2-AA	- 100 500 1000 2750 5500 11000 2.5	7.0 10.0 5.7 9.7 6.7 8.0 6.7 206.0	2.0 4.0 1.5 2.3 2.1 1.0 2.5 17.8	- 1.4 0.8 1.4 1.0 1.1 1.0 29.4	5, 7, 9 6, 14, 10 7, 4, 6 11, 11, 7 5, 9, 6 9, 7, 8 9, 7, 4 200, 192, 226
TA 100	Water Test item           2-AA	- 100 500 1000 2750 5500 11000 2.5	111.3 118.0 103.0 104.3 126.3 123.0 109.3 2141.0	6.1 18.0 12.5 20.5 11.5 15.5 5.5 37.2	- 1.1 0.9 0.9 1.1 1.1 1.0 19.2	110, 118, 106 123, 133, 98 115, 90, 104 92, 93, 128 133, 113, 133 124, 138, 107 104, 115, 109 2170, 2099, 2154
TA 1537	Water Test item           2-AA	- 100 500 1000 2750 5500 11000 2.5	9.0 9.0 9.7 7.0 11.3 7.3 5.7 127.3	3.5 3.6 0.6 3.5 0.6 5.0 1.5 14.2	- 1.0 1.1 0.8 1.3 0.8 0.6 14.1	13, 7, 7 8, 13, 6 9, 10, 10 9, 3, 9 11, 11, 12 2, 8, 12 6, 7, 4 111, 137, 134
TA 98	Water Test item           2-AA	- 100 500 1000 2750 5500 11000 2.5	24.7 27.0 23.7 21.7 20.3 22.0 19.0 1494.3	2.5 4.4 5.9 7.5 3.1 9.2 1.7 318.9	- 1.1 1.0 0.9 0.8 0.9 0.8 60.6	27, 22, 25 32, 25, 24 28, 26, 17 22, 14, 29 23, 21, 17 12, 30, 24 18, 18, 21 1234, 1399, 1850
E.coli	Water Test item           2-AA	- 100 500 1000 2750 5500 11000 60	30.3 30.7 29.0 23.0 28.7 30.0 23.0 127.3	7.1 1.5 6.6 6.2 4.0 3.0 4.6 16.1	- 1.0 1.0 0.8 0.9 1.0 0.8 4.2	29, 24, 38 29, 31, 32 28, 36, 23 16, 28, 25 33, 28, 25 33, 27, 30 28, 22, 19 134, 139, 109

Table 6: Historical negative control data

Strain	S9 Mix	Vehicle	No. of Plates	No. of Values	Min	Max	Mean	SD
TA 1535	Without With	(All) (All)	414 414	152 152	7 6	16 18	10 10	2.0 2.0
TA 100	Without With	(All) (All)	426 417	152 153	71 70	132 147	100 107	11.4 13.7
TA 1537	Without With	(All) (All)	411 411	152 152	5 5	13 16	8 9	1.7 2.1
TA 98	Without With	(All) (All)	420 413	152 152	14 12	34 38	21 28	3.3 4.5
E.coli	Without With	(All) (All)	396 399	152 152	15 17	34 36	24 25	3.9 4.4

Table 7: Historical positive control data

Strain	S9 Mix	Positive Control	No. of Plates	No. of Values	Min	Max	Mean	SD
TA 1535	Without With	MNNG 2-AA	312 312	110 110	1541 105	6171 520	3967 197	1253.9 56.3
TA 100	Without With	MNNG 2-AA	315 309	110 111	1126 272	5557 3021	3298 1748	1109.6 587.2
TA 1537	Without With	AAC 2-AA	309 312	110 110	253 50	2190 399	1044 141	404.3 50.3
TA 98	Without With	NOPD 2-AA	309 315	110 110	324 493	1746 3096	863 1524	206.8 529.1
E.coli	Without With	4-NQO 2-AA	306 306	110 110	164 61	1721 537	860 133	431.9 61.8

Conclusions:

Under the experimental conditions chosen here, it is concluded that the test substance is not a mutagenic test substance in the bacterial reverse mutation test in the absence and the presence of metabolic activation.

Executive summary:

The test substance was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay.

Strains: TA 1535, TA 100, TA 1537, TA 98 and E.coli WP2 uvrA

Dose Range: 100 µg - 11000 µg/plate (SPT), 100 µg - 11000 µg/plate (PIT)

Test Conditions: Standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (liver S9 mix from induced rats).

Solubility: No precipitation of the test substance was found with and without S9 mix.

Toxicity: A weak bacteriotoxic effect was occasionally observed depending on the strain and test conditions from about 5500 µg/plate onward.

Mutagenicity: A relevant increase in the number of his+ or trp+ revertants (factor ≥ 2: TA 100, TA 98 and E.coli WP2 uvrA or factor ≥ 3: TA 1535 and TA 1537) was not observed in the standard plate test or in the preincubation test without S9 mix or after the addition of a metabolizing system.

Under the experimental conditions of this study, the test substance is not mutagenic in the Salmonella typhimurium / Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Genetic toxicity in vitro

Ames

The test substance was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay.

Strains: TA 1535, TA 100, TA 1537, TA 98 and E.coli WP2 uvrA

Dose Range: 100 µg - 11000 µg/plate (SPT), 100 µg - 11000 µg/plate (PIT)

Test Conditions: Standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (liver S9 mix from induced rats).

Solubility: No precipitation of the test substance was found with and without S9 mix.

Toxicity: A weak bacteriotoxic effect was occasionally observed depending on the strain and test conditions from about 5500 µg/plate onward.

Mutagenicity: A relevant increase in the number of his+ or trp+ revertants (factor ≥ 2: TA 100, TA 98 and E.coli WP2 uvrA or factor ≥ 3: TA 1535 and TA 1537) was not observed in the standard plate test or in the preincubation test without S9 mix or after the addition of a metabolizing system.

Under the experimental conditions of this study, the test substance is not mutagenic in the Salmonella typhimurium / Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.

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 1272/2008. No indication of genotoxicity was observed in the Ames test (OECD 471, GLP). As a result, the substance is not considered to be classified for mutagenicity under Regulation (EC) No. 1272/2008, as amended for the tenth time in Regulation (EC) No. 2017/776.