Registration Dossier

Administrative data

Description of key information

The acute oral toxicity of the substance was assessed using:
- an acute oral toxicity test performed in rats according to OECD 423 guideline and Good Laboratory Practices (Pelcot, 2010)
The substance is of moderate acute toxicity following oral exposure:
The oral LD50 was comprised between 300 and 2000 mg/kg bw in rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50

Additional information

In the study of Pelcot (CIT 2010a), the acute oral toxicity of the test item was evaluated in rats according to OECD (No. 423, 17th December 2001) and Commission Regulation (EC) (No. 440/2008, B.1tris, 30 May 2008) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.  

The test item was prepared in corn oil and was administered by oral route (gavage), under a volume of 10 mL/kg, to groups of three fasted female Sprague-Dawley rats.The study design was as follows: The starting dose-level was 300 mg/kg bw. As no deaths occured, another assay was carried out on 3 animals at 2000 mg/kg bw . After this second assay as 1/3 animals died, the results were confirmed in 3 other animals at the dose-level of 2000 mg/kg bw. As all animals died in the third assay , another assay was carried out at 300 mg/kg bw.

At each step, clinical signs, mortality and body weight gain were checked for a period of up to 14 days following the single administration of the test item. All animals were subjected to necropsy.

At dose-level of 300 mg/kg: first step (three females): No mortality and no clinical signs were noted at this dose-level.When compared to CIT historical control data, the body weight gain of the animals was not affected by treatment with the test item.At necropsy, no apparent abnormalities were observed in any animal.

Atdose-level of 2000 mg/kg: first step (three females):One female was found dead on day 6. Hypoactivity, piloerection, tremors, hypersensitivity to the touch, exophthalmia and rhinorrhea were noted prior to its death. In the surviving animals, hypoactivity or sedation, piloerection, tremors, dyspnea, exophthalmia, rhinorrhea, ocular secretion, hypersensitivity to the touch and ataxia were noted between day 3 and day 7 or 9.A body weight loss (-8%) was noted in 1/2 surviving animals between day 1 and day 8. When compared to CIT historical control animals, a lower body weight gain (vs. 41 ±in control data base) was observed in the other female between day 1 and day 8. In both animals, the body weight gain returned to normal between day 8 and day 15.At necropsy, no apparent abnormalities were observed in any animal.
In the s
econd step (confirmation on three other females
):Two females were found dead (day 3; day 4). Piloerection, hypoactivity and dyspnea were noted prior to the death (day 4) of only one of them. No clinical signs were observed before death of the other female.Piloerection, hypoactivity then sedation, dyspnea, cold to the touch and body weight loss (-26%) was observed in the third female. According to the severe clinical signs observed, this animal was sacrificed on day 8 for ethical reasons.At necropsy, no apparent abnormalities were observed in any animal. 

At dose-level of 300 mg/kg: second step (confirmation on three other females): No mortality and no clinical signs were observed at this dose-level.When compared to CIT historical control data, a lower body weight gain (vs. 15 ±in control data base) was noted in 1/3 females between day 8 and day 15.At necropsy, no apparent abnormalities were observed in any animal. 

Under these experimental conditions, the oral LD50of the test item was comprised between 300 and 2000 mg/kg in rats. 

Justification for classification or non-classification

According to the criteria laid down in EU regulation (EC) n° 1272/2008/EC (CLP), the substance is classified in category 4 of toxicity with the hazard statement H302.

The corresponding classification according to the EU directive67/548/EEC is Harmful with the risk phrase R22.