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Description of key information

LD50 oral (rat): > 5000 mg/kg bw. Therefore ITC 288/S is considered as not Harmful by oral route.

LD50 dermal (rat): > 2000 mg/kg bw. Therefore ITC 288/S is considered as not Harmful by dermal route.

Key value for chemical safety assessment

Additional information

1- Acute oral toxicity:

Two studies were available with reliability 1 and 2 according to Klimisch rating (Kr).

- A study report (Tuffnell, 1992) has been chosen as key study for this endpoint (Kr: 1). This study was conducted according to OECD guideline 401 and in compliance with GLP. Groups of Sprague-Dawley rats (5/sex/group) were administered by gavage a single dose of ITC 288/S as a solution in distilled water at dose level of 5000 mg/kg bw and observed for 14 days. There were no deaths. No signs of systemic toxicity were noted during the study. Moreover, all animals showed expected gain in body weight during the study. No abnormalities were noted at necropsy. The oral LD50 combined of ITC 288/S was found to be greater than 5000 mg/kg bw.

- A study report (Cuthbert and Jackson, 1991) has been chosen as supporting study. Groups of Sprague-Dawley rats (five males and five females) were given a single oral dose of ITC 288/S, as a solution in distilled water at dose level of 2000 mg/kg body weight and observed for 14 days. As in the key study, there were no deaths, no clinical signs and no abnormailties at necropsy.The LD50 (males and females) of ITC 288/S was found to be greater than 2000 mg/kg bw.

Taken together these results show that ITC 288/S is not harmful via oral route.

2- Acute dermal toxicity:

Two studies were available with reliability 1 and 2 according to Klimisch rating (Kr).

- A study report (Tuffnell, 1992) has been chosen as key study for this endpoint (Kr: 1). This study was conducted according to OECD guideline 402 and in compliance with GLP. Groups of Sprague-Dawley rats (5/sex/group) were dermally exposed to ITC 288/S undiluted at dose level of 2000 mg/kg bw and observed for 14 days. There were no deaths. No signs of toxicity or skin irritation were noted during the study. Moreover, all animals showed expected gain in body weight. No abnormalities were noted at necropsy. The dermal LD50 combined of ITC 288/S was found to be greater than 2000 mg/kg bw.

- A study report (Cuthbert and Jackson, 1991) has been chosen as supporting study. Groups of Sprague-Dawley rats (five males and five females) were dermally treated for 24 hours with ITC 288/S undiluted at dose level of 2000 mg/kg body weight and observed for 14 days. As in the key study, there were no deaths, no clinical signs related to treatment and no abnormailties at necropsy. The LD50 (males and females) of ITC 288/S was found to be greater than 2000 mg/kg bw.

Taken together these results show that ITC 288/S is not harmful via dermal route.

3- Acute inhalation toxicity:

No data available for this route of administration.

Justification for classification or non-classification

1- Acute oral toxicity:

Not classified according to the EU legislation (Directive 67/548/EEC and CLP regulation (1272/2008)) as the oral LD50 combined of ITC 288/S was found to be greater than 5000 mg/kg bw.

2- Acute dermal toxicity:

Not classified according to the EU legislation (Directive 67/548/EEC and CLP regulation (1272/2008)) as the dermal LD50 combined of ITC 288/S was found to be greater than 2000 mg/kg bw.

3- Acute inhalation toxicity:

No classification is possible due to lack of data