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Administrative data

Description of key information

The key study for acute oral toxicity (van Otterdijk, 2003) reported an oral LD50 of >2000 mg/kg bw.
The key study for acute dermal toicity (van Otterdijk, 2003) reported a dermal LD50 of >2000 mg/kg bw.

Key value for chemical safety assessment

Additional information

Key value for chemical safety assessment

Acute toxicity: oral

Effect level LD50 in mg/kg bw >2000

Acute toxicity: dermal

Effect level LD50 in mg/kg bw >2000

The key study for acute oral toxicity (van Otterdijk, 2003) was conducted according to the OECD 423 guideline under GLP conditions. The study was performed on male and female Wistar rats with an observation period of 14 days. The study was conducted as a limit test using a single test concentration of 2000 mg/kg bw in corn oil via oral gavage. Although red discolouration of feaces was noted this was determined not to be toxicologically significant. No other observations were recorded.

Based upon these findings the acute oral LD50 was considered to be >2000 mg/kg bw.

The study was awarded the reliability score of 1 according to the criteria of Klimisch et al (1997).

The key study for acute oral toxicity (van Otterdijk, 2003) was conducted according to the OECD 402 guideline under GLP conditions. The study was performed on male and female Wistar rats with an observation period of 14 days. The study was conducted as a limit test using a single test concentration of 2000 mg/kg bw in propylene glycol. An occlusive dressing was used to achieve a 24 hour exposure time. red or yellow staining and irritation was noted at the test site in all cases and alopecia and/or scabs on the cheek region were noted in 3 males. No other significant local or systemic signs of toxicity were noted.

Based upon these findings the acute oral LD50 was considered to be >2000 mg/kg bw.

The study was awarded the reliability score of 1 according to the criteria of Klimisch et al (1997).

Justification for classification or non-classification

Based upon the key information the registered substance does not meet the criteria for classification according to EC Regulation 1272/2008 or directive 67/548/EEC.