6-methyl-1,2,3-oxathiazin-4(3H)-one 2,2-dioxide, potassium salt

Endpoint summary

Description of key information

In rats, the oral LD50 values and 95% confidence limits were 5438 (4839-5994) mg/kg bw for males and 5565 (5083-6071) mg/kg bw for females, while the dermal LD50 value was >2000 mg/kg bw. 
In mice, the oral LD50 values and 95% confidence limits were 5438 (4839-5994) mg/kg bw for males and 5565 (5083-6071) mg/kg bw for females.
No standard study on acute toxicity after inhalation is available. However, no inhalation toxicity of thermal degradation products tested at 250 °C was noted.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 534 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

mg/kg bw

Additional information

The oral acute toxicity of Acesulfame potassium was examined in rats (10 males and10 females/group).The oral LD50 values and 95% confidence limits were 5438 (4839 -5994) mg/kg bw for males and 5565 (5083 -6071) mg/kg bw for females. Major symptoms observed were a decrease in spontaneous movement, crawling, convulsions and diarrhea. The suppression of body weight gains was trendently observed at 4167 and 5000 mg/kg bw males, and at 5000 mg/kg bw females. There was no difference in body weight between the treated groups and control group at the end of observation period. The autopsy of dead animals revealed hemorrhage in the gastric mucosa, hyperemia in the small intestine and cecum, congestion in the lung, and petechial hemorrhage in the thymus. The autopsy of surviving animals exhibited no macroscopic abnormalities in any organs in either sex.

The oral acute toxicity of Acesulfame potassium was examined in mice (10 males and10 females/group).The oral LD50 values and 95% confidence limits were 6974 (6188 - 8369) mg/kg bw for males and 6713 (6103 - 7521) mg/kg bw for females. Major symptoms observed were a decrease in spontaneous movement, crawling, convulsions and sedation.

The autopsy of dead animals revealed hemorrhage in the gastric mucosa, hyperemia in the small intestine and cecum, congestion in the lung, and petechial hemorrhage in the thymus. The autopsy of surviving animals exhibited no macroscopic abnormalities in any organs in either sex.

Acesulfame potassium was investigated at a temperature of 250°C in a study of the inhalation toxicity of thermal degradation products. All test animals survived. Symptoms of intoxication were disturbance of respiration, of autonome reactionsand of body position. The investigation of CO hemoglobin did not show increased CO-Hb values immediately after exposure. Pathological examination of the animals killed immediately after the study did not show any abnormal signs.

The acute dermal toxicity study was performed with Acesulfame potassiumin Wistar rats (CRL:(WI)) in compliance with OECD Guideline No. 402,Commission Regulation (EC) No 440/2008, B.3 and OPPTS 870.1200. A limit test was carried out at 2000 mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was applied as a single dermal 24 -hour exposure followed by a 14‑day observation period. Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. Gross macroscopic examination was performed on all animals at the end of the 2-week observation period (Day 14). The test item did not cause any mortality at the dose level of 2000 mg/kg bw. No clinical signs were observed during the treatment with the test item or thereafter within the 14 day observation period. No dermal signs were observed after treatment with the test item. There were no effects on body weight or body weight gain in any animal during the study. There was no evidence of any observations at the dose level of 2000 mg/kg bw at necropsy. The median lethal dose of Acesulfame potassium after a single dermal administration was found to be greater than 2000 mg/kg bw in male and female CRL:(WI) rats.

Justification for classification or non-classification

Acesulfame potassium was non-toxic after acute oral and dermal administration.

The study results triggers the following classification/labelling:

EU Directive 1999/45/EC (as amended):        none

Regulation (EC) No 1272/2008 (CLP):           none

GHS (rev. 4) 2011:                                      unclassified