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Description of key information

Oral exposure to TS-ED 532 is the most relevant route of human exposure. 
No adverse signs of toxicity were observed in a 90-day oral toxicity study in rats using TS-ED 532 at dietary concentrations of 0.4, 1.2, or 3.6% (corresponding to approx. dose levels of 500, 1600 and 5000 mg/kg bw/day, respectively). Therefore, the NOAEL was established as ≥ 5000 mg/kg bw/day in both sexes, based on no adverse treatment-related effects at the highest dose tested.
The oral administration of TS-ED 532 to rats for a period of up to 12 months at dietary concentrations of up to 30000 ppm (equivalent to a mean overall intake of 1333 mg/kg bw/day for males and females) did not result in effects that were considered to represent an adverse effect of treatment. Therefore, the NOAEL was established as ≥ 1333  mg/kg bw/day in both sexes, based on no adverse treatment-related effects at the highest dose tested.
Due to the low vapour pressure indicating that TS-ED 532 is not volatile, absorption via the respiratory system is considered to be unlikely. Inhalation of TS-ED 532 is therefore not a relevant route of human exposure.
The acute dermal toxicity of TS-ED 532 was found to be greater than 2000 mg/kg bodyweight via occlusive application. This indicates that dermal absorption of TS-ED 532 is low and that a possible systemic effect via dermal absorption is neglible.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 333 mg/kg bw/day
Study duration:
chronic
Species:
rat

Additional information

The repeated oral dose toxicity of TS-ED 532 was investigated in a 90-day study and a chronic study, both using dietary administration. No adverse signs of toxicity were observed in the 90-day oral toxicity study in rats using TS-ED 532 at dietary concentrations of 0.4, 1.2, or 3.6% (corresponding to approx. dose levels of 500, 1600 and 5000 mg/kg bw/day, respectively). Therefore, the NOAEL was established as ≥ 5000 mg/kg bw/day in both sexes, based on no adverse treatment-related effects at the highest dose tested.

The oral administration of TS-ED 532 to rats for a period of up to 12 months at dietary concentrations of up to 30000 ppm (equivalent to a mean overall intake of 1333 mg/kg bw/day for males and females) did not result in effects that were considered to represent an adverse effect of treatment. Therefore, NOAEL was established as ≥ 1333 mg/kg bw/day in both sexes, based on no adverse treatment-related effects at the highest dose tested.

The repeated dose inhalation toxicity of TS-ED 532 was not investigated. TS-ED 532 is a transparent liquid with an estimated vapour pressure of 1.1x10-7 Pa at 25 °C and 4.8x10-8 Pa at 20 °C. The low vapour pressure indicates that TS-ED 532 is not volatile and that absorption via the respiratory system is unlikely. Inhalation of TS-ED 532 is therefore not the most relevant route of human exposure.

The repeated dose dermal toxicity of TS-ED 532 was not investigated. The acute dermal toxicity of TS-ED 532 was found to be greater than 2000 mg/kg bodyweight via occlusive application. This indicates that dermal absorption of TS-ED 532 is low and that possible systemic effects via dermal absorption are neglible.

Overall, oral exposure is the most relevant route of human exposure. The lowest identified NOAEL for repeated dose toxicity was ≥ 1333 mg/kg bw/day for both sexes, identified from a chronic toxicity study.

Justification for classification or non-classification

Oral exposure to TS-ED 532 is the most relevant route of human exposure. TS-ED 532 was shown to have a low oral repeat-dose toxicity hazard when tested in a 90-day toxicity study and a chronic toxicity study. The lowest identified NOAEL was ≥

1333 mg/kg bw/day for both sexes, identified from the chronic toxicity study.

Based on the obtained data, TS-ED 532 is not hazardous and is not classified according to GHS and DSD-DPD.