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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 401 guideline and Good Laboratory Practices (Dufour, 1997)
The substance is of moderate acute toxicity following oral exposure:
The oral LD50 was comprised between 500 and 2000 mg/kg bw in rats..
The acute dermal toxicity of the substance was assessed using:
- An acute dermal toxicity test performed in rats according to OECD 402 guideline and Good Laboratory Practices (Manciaux, 1998).
The substance is of low acute toxicity following dermal exposure:
The oral LD0 was found to be greater than 2000 mg/kg bw.
No inhalation toxicity study was performed on the substance due to its corrosive properties.

Key value for chemical safety assessment

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Acute Oral Toxicity:

One reliable without restriction study was reported for the acute oral toxicity endpoint and was selected as a key study.

The study of Dufour (1997), was designed to evaluate the acute oral toxicity of the test substance in rats according to OECD guideline 401. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.  

The test substance was prepared in Carboxymethyl cellulose at 05% and was administered by oral route (gavage), under a volume of 5 mL/kg bw, to groups of five fasted male and female Sprague-Dawley rats. The dose-levels of 500 and 2000 mg/kg bw were selected on the basis of the results obtained in a preliminary sighting study.

In the main study, 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 the 500 mg/kg bw dose-level, no mortality occured. A slight piloerection that appeared 30 minutes after the treatment and disappeared in less than 24 hours was the only clinical sign. The body weight gain of the animals was not affected by treatment with the test item and no apparent abnormalities were observed in any animal at necropsy.

At the 2000 mg/kg bwdose-level,70% (4/5 males and 3/5 females) of the animals died within the study period. Most of the deaths occured 24 to 72 hours after treatment .An important piloerection, a slight abdominal meteorism and a dirty urogenital area were noted in the surviving animals from day 2 to day 8. All animals lost weight at 72 hours but females (not males) recovered at day 8.Necropsy of animals found dead revealed changes in liver, spleen, kidney, lung, intestine and abdominal wall. Necropsies of animals surviving until end of study did not reveal any changes.

Under these experimental conditions, the oral LD50of the test substance was comprised between 500 and 2000 mg/kg in rats. 

Acute dermal Toxicity:

One study is recorded for this endpoint.The study of Manciaux (1998) was reliable without restrictions andselected as a key study.

The study of Manciaux (1998) was conducted to evaluate the potential acute dermal toxicity of the substance in rats

The study was performed according to OECD guideline 402 and EU method B.3 in compliance with the principles of Good Laboratory practices. As the test substance was anticipated to be non-toxic at 2000 mg/kg bw, a limit test was performed by application of 2000 mg/kg bw of the test substance to one group of five male and five female Sprague-Dawley rats. The undiluted test substance was applied to the skin and the test site was then covered by a semi-occlusive dressing for 24 hours. Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single application of the test substance. All animals were subjected to necropsy. No mortality and no clinical signs were observed during the study period. The body weight gain was reduced in 1 male and 2 females between days 1 and 8 but returned to normal thereafter. Skin erythema was observed in all rats on day 2 and persisted up to the end of the observation period in 3 out of 5 females. Crusts were also observed in all animals from day 3 up to the end of the study. Necrosis was observed in 1 male and 1 female between day 4 and 7 and dryness of skin was observed in 2 males on days 14 and 15. At necropsy, no apparent abnormalities were detected. The dermal LD0 of the test substance was equal or higher than 2000 mg/kg bw in rats.

Acute inhalation Toxicity:

The substance is classified as corrosive and testing for acute toxicity is therefore not needed according to REACH regulation (EC) 1907/2006 (Annex VII, point 8.5, column 2). Additionally, based on the low vapour pressure of the substance a significant risk concerning inhalation is not anticipated.

Justification for classification or non-classification

Based on the results of the study conducted by Dufour (1997) and according to the criteria laid down in EU directive67/548/EEC, the substance is

classified Harmful with the risk phrase R22

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.

Based on the results of the study conducted by Manciaux (1998) and according to the criteria laid down in EU regulation (EC) n° 1272/2008/EC (CLP) and EU directive67/548/EEC, the substance is not classified for acute dermal toxicity.

Due to the low vapour pressure of the substance, exposure to either aerosols or fumes of the substances is unlikely. Therefore no classification for acute inhalation toxicity is deemed necessary according to EU regulation (EC) n° 1272/2008/EC (CLP) and EU directive67/548/EEC.