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Description of key information

Oral (Standard Acute Method), rat: LD50: 396 mg/kg bw, 1986; RL = 1
Oral (Standard Acute Method), rat: LD50: 242 mg/kg bw, 1984; RL = 2
Oral (Standard Acute Method), mouse: LD50: 141 mg/kg bw, 1963; RL = 2
Oral (Standard Acute Method), rabbit: LD50: 35 mg/kg bw, 1964; RL = 2
Oral (Standard Acute Method), cat: LD50: 35 mg/kg bw, 1964; RL = 2
Inhalative (Inhalation Hazard Test), LC0 = 1.24 mg/L air (nominal), 1963; RL = 2
Dermal (Limit test), rat: LD0 = 1884 mg/kg bw, 1963; RL = 4

Key value for chemical safety assessment

Additional information

Acute oral toxicity

Acute oral toxicity was assessed by a Weight of evidence approach. Two acute oral toxicity studies in rats are available. The first was performed according to the OECD guideline 401. 5 Wistar rats per sex per group were administered the test substance (> 90% pure) at doses of 100, 300, 1000 and 5000 mg/kg bw in 4% CMC per gavage. Sedation, curved body position and ruffled fur were observed in all dose groups. Additionally, dyspnoea, ataxia and somnolence were observed in the higher dose groups. The surviving animals recovered within 3 to 5 days. No animal died in the lowest dose group, 2/10 in the 300 mg/kg bw group and in the 1000 and 5000 mg/kg bw; the animals died mainly within the first hours after application. All animals were observed for clinical signs for 14 days and necropsied. The LD 50 was 396 mg/kg bw resulting in category 4. The study is suitable for assessment as it was performed according to guideline (BASF AG, 1986).

The second study was performed similar to the OECD guideline. 5 Wistar rats per sex per group were administered the test substance (98% pure). 9/10 animals died at 316 mg/kg bw and 3/10 at 215 mg/kg bw. All clinical symptoms (dyspnoea, apathy, excitation, abnormal body position, staggering, tremor, piloerection, skin redness and poor general state) were reversible within a few days. The LD 50 was 242 mg/kg bw resulting in category 3. The study is suitable for assessment as it was performed according to a protocol similar to the OECD guideline (BASF AG, 1984).

The remaining studies were conducted with other species (mouse, rabbit and cat) and not according to any guideline as they were performed in 1963. Nevertheless, the results indicate an oral toxicity of the test substance (LD 50, mouse: 141 mg/kg bw; LD 50, rabbit: 35 mg/kg; LD 50, cat: 35 mg/kg bw). Moreover, the study in cats demonstrates that the test substance is not a methemoglobine former.

As the reference specie for classification is the rat and the second study was conducted with a test substance of a higher purity and an adequate dose selection, classification for acute oral toxicity is warranted as category 3.

 

Acute inhalative toxicity

In an acute inhalation study, groups of 3 rats per sex were exposed to an atmosphere enriched with the vapours of the test substance. The Inhalation Hazard Test was performed according to a protocol similar to the OECD test guideline 403 (adopted 1983). The test concentrations were calculated based on the weight difference of the test substance before and after exposure and no further analytics were performed. The higher concentration of both experiments (1.24 mg/L and 0.018 mg/L) is still below the calculated concentration of a saturated atmosphere (2.3 mg/L; calculated assuming test substance vapour pressure = 41 hPa). Thus, no classification for acute inhalation toxicity is possible but as the LC0 is 1.24 mg/L, category 1 can be excluded. Therefore, the test substance is not considered to be highly toxic by inhalation. The study is reliable and suitable for assessment but not sufficient for classification (BASF AG, 1963).

 

Acute dermal toxicity

No reliable data available.

Justification for classification or non-classification

Dangerous substance Directive (67/548/EEC)

The available experimental test data are considered reliable and suitable for the purpose of classification. Based on the criteria for classification of Directive 67/548/EEC, as amended for the 28thtime in Directive 2001/59/EC, classification for acute oral toxicity is warranted as “R 22”.

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification. Based on the criteria laid down in Regulation (EC) No. 1272/2008, as amended for the 2ndtime in Directive EC 286/2011, classification for acute oral toxicity is warranted as “category 3”.

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