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Description of key information

Oral - rat LD50 = 8270 mg/kg bw (BASF AG 1980)
Dermal - rat LD50 > 5000 mg/kg bw (Moreno 1976)
Inhalation - Rat: IHT: 8h: no mortality in a saturated vapour atmosphere (BASF 1980)
Dermal - Rabbit: LD 50 > 5000 mg/kg bw (Moreno 1976)

Key value for chemical safety assessment

Additional information

Acute oral toxicity:

In the key study, i.e. a limit test, five male and five female Sprague-Dawley rats were treated with 10 ml/kg bw equivalent to approx. 8270 mg/kg bw (BASFAG XXVI402). The animals were observed for 14 d, necropsy was performed with dead animals and survivors. The LD50 was 8270 mg/kg bw for male and female rats. 1/5 males died within 48 h; 3/5 females died within 24 h. Clinical signs of toxicity, i.e dyspnea, apathy, lateral position, staggering, atonia, sedative-like state with loss of corneal and pain reflex, ataxia, spastic movements, diarrhea, salivation and lacrimation, poor general condition and reduced weight gain at beginning of study, were observed. Gross pathology revealed acute dilatation of the heart and slightly brightened kidneys in the deceased animals, whereas in the organs of the sacrificed animals nothing abnormal was detected.

In the supporting study, ten rats (sex was not specified) were administered 5000 mg/kg bw, respectively (Moreno 1976). No mortality was observed, resulting in a LD50 > 5000 mg/kg bw, and the only clinical sign reported was lethargy.

Data on acute oral toxicity in mice, available short reference from secondary source provide an LD50 values of 4500 mg/kg bw (Melceva 1990).

 

Acute inhalation toxicity:

In a supportive study, i.e. an inhalation hazard test, exposure to an atmosphere

 beeing saturated with the volatile part of tetrahydrolinalool at 20°C, 0/12 rats died after 8 h exposure (BASFAG XXVI402). No clinical signs were observed and there were no necropsy findings in the survivors after 2 day observation period.

No key study is available, however, supportive evidence from an inhalation hazard test does not indicate an acute inhalative toxicity of tetrahydrolinalool and a study on acute dermal toxicity, covering a relevant route of exposure, is present.

Acute dermal toxicity:

In the key study, available from secondary sources beeing cited in a peer reviewed publication, tetrahydrolinalool was administered to 10 rabbits (Moreno 1976). The type of coverage was not further specified. The LD50 was reported to be >5000 mg/kg bw.

Acute intraperitoneal toxicity:

Intraperitoneal injection of tetrahydrolinalool in carboxymethyl cellulose to groups of 5 mice per sex and dose resulted in an LD50 of 0.55 ml/kg (approx. 455 mg/kg bw; BASFAG XXVI402).

Taken together, the present data do not indicate an acute toxic potential of tetreahdrolinalool via different routes of exposure.

Justification for classification or non-classification

The present data on acute oral and dermal toxicity do not fulfill the criteria laid down in 67/548/EEC and 1272/2008/EEC, and therefore, a non-classification is warranted.