Registration Dossier

Administrative data

Description of key information

The notifiable substance is of low acute toxicity following oral exposure, with no mortality, clinical signs, or adverse effects on body weight reported in mice and rats at a dose of up to 24.37 g/kg body weight (Dupas, 1982). 

The notifiable substance is of low toxicity following intravenous and intraperitoneal exposure. No mortalities or clinical signs were observed in male and female mice at an intravenous concentration of 6.39 and 8.15 g/kg body weight, respectively. Likewise, no mortalities or clinical signs were observed in mice or rats at an intraperitoneal concentration of approximately 13 g/kg body weight of Lycasin®. No LD50 value has been identified for Lycasin® for any route of exposure.

Key value for chemical safety assessment

Additional information

Acute oral: 

Groups of male and female mice and rats were orally administered Lycasin® by gavage in a study performed similar in methodology to OECD Guideline for the Testing of Chemicals No. 423 (Dupas, 1982) and which was therefore deemed as the key study. Groups of OF1 Swiss mice received a single dose of 14.62, 19.50, or 24.37 g/kg body weight of Lycasin® and groups of Sprague-Dawley rats received a single dose of 24.37 g/kg body weight of Lycasin®, and both mice and rats were observed for 14 days. No significant clinical signs were observed in mice during the study period and no details on clinical signs were provided in rats. No compound-related changes in body weight were reported in mice or rats administered Lycasin® and their respective control groups. No mortalities were observed in either mice or rats. Thus, the LD50 could not be determined.

 

Acute intravenous:  

In a supporting study, groups of male and female OF1 Swiss mice were intravenously administered a single dose of Lycasin® at dose of 1.32, 2.56, 3.97, 5.17, or 6.39 g/kg body weight and 1.48, 3.08, 4.82, 6.25, or 8.15 g/kg body weight, respectively. No significant clinical signs were observed during the 14-day observation period and gross pathology was not examined in the study. No mortalities were reported during the study period. Thus, the LD50 could not be determined. 

 

Acute intraperitoneal:

In another supporting study, groups of male and female Swiss mice were injected with doses of Lycasin® up to 10.64 and 12.43 g/kg body weight, respectively (Dupas, 1982). In male and female Sprague-Dawley rats, a single dose of Lycasin® was injected intraperitoneally at 13 g/kg body weight. In mice and rats, no clinical signs and no mortalities were reported in both Lycasin-treated groups and control groups. Therefore, no LD50 value could be determined for mice or rats.

Justification for classification or non-classification

Acute Oral Toxicity: The notifiable substance has an acute oral LD50 of greater than 2000 mg/kg bw (acute oral LD50 > 24370 mg/kg bw). As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.1.

 

Acute Dermal Toxicity: While no acute dermal information is available for the notifiable substance, the intravenous data (no deaths after receiving a single intravenous dose of up to 6390 mg/kg bw) represents a worst case scenario and supports the assumption that the acute dermal LD50 would be greater than 2000 mg/kg bw. Additionally, log Kow values of less than –1 (actual value was log Kow <-2) suggest that a substance is not likely to be sufficiently lipophilic to cross the stratum corneum, therefore dermal absorption is likely to be low. As a result of expert judgement, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.1.

 

Acute Inhalation Toxicity: There is no information available concerning inhalation toxicity.

 

Specific Target Organ Toxicity– Single Exposure: The notifiable substance did not exhibit significant toxic effects arising from a single exposure. As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.8.