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EC number: 823-920-1 | CAS number: 5341-95-7
Genetic toxicity in vitro
- Bacteria reverse mutation test: negative
- Mammalian chromosome aberration test: negative
- Mammalian cell gene mutation test: negative
The test substance (2R,3S)-butane-2,3 -diol was evaluated for its potential to induce chromosome aberration by performing the in vitro mammalian chromosomal aberration test with cultured Chinese hamster lung cell line (CHL) in the absence (S9 -) and presence (S9 +) of metabolic activation system. The study was performed according to OECD 473 (adopted 2016) and in compliance with GLP. Concentration range-finding test was performed on cell cultures using a short-term treatment assay in the absence of S9 mix (referred to as –S9 mix) and in the presence of S9 mix (referred to as +S9 mix) and continuous treatment test (referred to as 24 hour exposure, S9 -). The concentration range used was 62.5, 125, 250, 500, 1000 and 2000 μg/mL. After 24 hours exposure, relative increase in cell counts (RICC) was observed by more than 60% at –S9 mix and +S9 mix. The RICC (55 ± 5) % was 559.35 μg/mL (24 hours exposure).
Based on the result of concentration range-finding test, concentrations of 125, 250, 500, 1000 and 2000 μg/mL were chosen for the main test. First, the chromosomal aberration test (short-term treatment method) was conducted with and without S9-mix. Results showed that the frequencies of aberration cells with structural aberration and numerical aberrations of chromosome were less than 5% for both S9- and S9+. Since all results were negative under both conditions of short-term treatments, chromosomal aberration test continuous treatment for 24 hour exposure without S9-mix and a second short-term treatment (S9+) followed. Continuous treatment (24 hour exposure) was conducted at 300, 400, 500, 600 and 700 μg/mL, and the second short-term treatment (+S9 mix) was conducted at 500, 1000 and 2000 μg/mL. Observation of specimens were conducted at all treatment groups in the 24 hour exposure and the second short-term test. Results showed that frequencies of aberration cells with structural aberration and numerical aberrations of chromosome were less than 5% in the long-term (S9-) and short-term (S9+) test. Therefore, the test substance was considered to be non-clastogenic (Negative) to CHL/IU cells under the present experimental condition.
The study was considered reliable and adequate for risk assessment.
Mutagenicity of the test substance (2R,3S)-butane-2,3 -diol was assessed in a bacterial reverse mutation assay using histidine requirement strains of Salmonella typhimurium TA100, TA1535, TA98 and TA1537 and tryptophan requirement of strain Escherichia coli WP2uvr A. The study was performed according to OECD 471 (adopted 1997) and in compliance with GLP. The test was conducted by the pre-incubation method in the presence and absence of S9 mix.
The concentration range-finding test was conducted with test concentrations of 50, 150, 500, 1500 and 5000 μg/plate. Microbial toxicity was not observed at any concentration in the presence and absence of S9 mix. Also, precipitation was not observed on the agar plates at any concentration in the presence and absence of S9 mix. Based on the results of the preliminary test, the main test I and II were conducted at the following concentrations without and with S9 mix: 313, 625, 1250, 2500, 5000 μg/plate (for strains TA98, TA100, TA1535, TA1537, WP2uvrA).
Microbial toxicity was not observed at any concentration in the presence and absence of S9 mix in the main tests. Also, precipitation was not observed on the agar plates at any concentration in the presence and absence of S9 mix. The number of revertant colonies in the test substance-treated groups was less than twice that in the corresponding negative control (vehicle: sterilised distilled water) in any test strain regardless of the presence or absence of S9 mix. Reproducibility of the test result was confirmed in main tests I and II.
The number of revertant colonies in the negative (vehicle) control and positive control groups were within the acceptable ranges stipulated at the testing facility. The positive controls used in the assays with and without S9 mix showed clear positive responses by the respective test strains, as evidenced by the number of revertant colonies being greater than 2-fold of the respective negative (vehicle) control value. Base on this results, it was concluded that the test item was not mutagenic (negative) under the conditions employed in the present study.
The study was considered reliable and adequate for hazard assessment.
relative cloning efficiency I
relative cell density
relative adjusted cloning efficiency I*
mutant colonies/10^6 cells**
95 confidence interval
Main Experiment / 4 h treatment
mean values of culture I and II
Solvent control with water
Positive control (EMS)
Positive control (DMBA)
*relative adjusted cloning efficiency I=relative cloning efficiency I x relative cell density at first subcultivation / 100
**mutant colonies / 10^6 cells=mean number of mutant colonies per flask found after plating in TG medium × 10^6 divided by the number of cells survived
The test substance (2R,3S)-butane-2,3 -diol was investigated for its the potential to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster. The study was conducted according to OECD 476 (adopted 2016) and in compliance with GLP. The experiment was performed with a treatment time of 4 hours with and without metabolic activation. Based on the results of a preliminary test, the main test were conducted at the following concentrations without and with S9 mix: 56.3, 112.6, 225.3, 450.5, 901.0 μg/mL.
No statistical significant increase of the mutation frequency at any test concentration or dose dependent increase of the mutation frequency was observed in the main experiment. Appropriate reference mutagens, used as positive controls, induced a significant increase in mutant colonies and thus, showed the sensitivity of the test system and the activity of the metabolic activation system. The study was considered reliable and adequate for risk assessment.
In the absence of information on species specific effects or metabolism the results are regarded as relevant for humans.
Genotoxicity in vitro
The submission substance does not need to be classified for germ cell mutagenicity according to the CLP regulation, because all results were negative obtained in experimental studies, i.e. in vitro studies according to OECD 471 (adopted 1997), OECD 473 (adopted 2016), and OECD 476 (adopted 2016).
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