1,4:3,6-dianhydro-2,5-bis-O-(diphenoxyphosphoryl)-D-glucitol

Endpoint summary

Description of key information

- Acute oral toxicity: OECD TG 423, rats; LD50 > 5000 mg/kg bw; no mortality occurred and no signs of systemic toxicity were observed up to 2000 mg/kg bw.
- Acute dermal toxicity: OECD TG 402, rats; LD50 > 2000 mg/kg bw; no mortality occurred and no signs of systemic toxicity were observed up to 2000 mg/kg bw.
- Acute inhalation toxicity: no data.

Additional information

Oral route

In an acute oral toxicity study performed according to the Acute Toxic Class method (BASF SE, 2011), doses of 2000 and 500 mg/kg bw of the substance (preparations in olive oil Ph.Eur.) were administered to three test groups of three fasted Wistar rats each (first step: 500 mg/kg bw in 3 females; second step: 2000 mg/kg bw in 3 females; and third step: 2000 mg/kg bw in 3 additional females; each following step conducted in the absence of mortality in the previous) by gavage in a sequential manner. No clinical signs were observed, no mortality occurred, no macroscopic pathological findings were observed, and the mean body weight increased within the normal range. Therefore the acute oral LD50 was calculated to be greater than 2000 mg/kg bw (greater than 5000 mg/kg bw when the results are interpreted based on the Annex 2 of the OECD TG 423).

The study was conducted according to the OECD test guideline 423 (GLP, Val 1). The only deviation was the use of 500 mg/kg bw as starting dose (first step) instead of 300 mg/kg bw, but, in the absence of mortality, does not influence the outcome, and the study is therefore considered sufficient for assessment and classification.

 

Dermal route

In an acute dermal toxicity study, young adult Wistar rats (5 animals per sex) were dermally exposed to a single dose of 500 or 2000 mg/kg bw of test substance (as suspension in olive oil Ph.Eur) to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi occlusive dressing for 24 hours (BASF SE, 2011). The application area comprised at least 10% of the total body surface area and the animals were observed for 14 days. Because no mortality occurred in either the 500 or the 2000 mg/kg test groups, the acute dermal median lethal dose (LD50) was determined to begreater than 2000 mg/kg bw. No signs of systemic toxicity or skin effects were observed in the animals of the 500 and 2000 mg/kg test groups, and the mean body weight of the animals increased within the normal range throughout the study period. Additionally, no macroscopic pathologic abnormalities were noted in the animals examined at necropsy.

As the study was conducted according to the OECD test guideline 402 without any restrictions (GLP, Val 1), it is considered sufficient for assessment and for classification.

 

Inhalation route

No data available.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data are considered reliable and suitable for the purpose of classification (dermal and oral routes). Based on the criteria for classification of Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC, no classification is warranted.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are considered reliable and suitable for the purpose of classification (dermal and oral routes). Based on the criteria laid down in Regulation (EC) No.1272/2008, as amended for the second time in Directive EC 286/2011, no classification is warranted.