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Endpoint summary

Description of key information

LD50 (estimated) = 127 mg/kg bw in rats

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

127 mg/kg bw

Quality of whole database:

Value estimated from in vitro toxicity study, with high reliability (R1)

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In vitro acute oral toxicity study - 3T3 NRU test (Neutral Red Uptake)

The objective of this study was to evaluate the basal cytotoxicity of the test item, using the 3T3 NRU test (Neutral Red Uptake). The design of the study is based on the OECD Guidance document No. 129 for "Guidance Document on using cytotoxicity test to estimate starting doses for accurate oral systemic toxicity tests". The NRU assay is performed in a dose-response format allowing the calculation of the concentration of the test item that reduces Neutral Red Uptake (NRU) by 50% (IC50). The IC50 value is used in a linear regression equation to estimate the oral LD50 value in rats. The assay evaluates the cytotoxicity of the test item applied to mouse fibroblasts (Balb/c 3T3, clone A 31).

In both experiments, the tested concentrations were: 0.03, 0.1, 0.32, 1, 3.17, 10.01, 31.65 and 100 µg/mL in DMEM₀. The following results were obtained after 48 hours incubation:

• strong cytotoxicity associated with rounded cells and decrease in cell viability (decrease in NRU) were noted at concentrations ≥ 3.17µg/mL,
• the calculated IC50 were 1.502 µg/mL and 1.791 µg/mL in the first and second experiments, respectively,
• these results correspond to estimated LD50 of 123 mg/kg and 131 mg/kg, in the first and second experiments, respectively.

Under the experimental conditions of this study and after treatment of cells for 48 hours, the test item, is considered as cytotoxic in thisin vitrotest system. The mean IC50 was estimated to be 1.647 µg/mL and the corresponding LD50 for rats was estimated to be 127 mg/kg according to OECD Guidance No. 129.

This result is in line with the LD50 values calculated for many vanadyl derivatives.

Justification for classification or non-classification

According to the CLP Regulation 1272/2008/EC, 3.1.2.1 section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1:

Oral (mg/kg bodyweight)

Category 1: LD50 ≤ 5

Category 2: 5 <LD50 ≤ 50

Category 3: 50 < LD50 ≤ 300

Category 4: 300 < LD50 ≤ 2 000

The LD50 for the substance under investigation is estimated to be 127 mg/kg body weight in rats, therefore, according to the CLP regulation n. 1272/2008, the substance is classifed as Toxic via Oral Route Category 3.