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Administrative data

Description of key information

Acute oral toxicity: LD50 rat 6800 mg/kg
Acute dermal toxicity: LD50 rat > 2000 mg/kg bw

Key value for chemical safety assessment

Additional information

Acute oral toxicity:

In the key study, citral was given to male and female Sprague Dawley rats (5 per dose) by gavage with carboxy methyl cellulose as vehicle at doses ranging from 2150 to 10 000 mg/kg bw. The oral LD50 was ca. 6800 mg/kg bw. Death occurred within several days and was preceeded by clinical signs of intoxication, i.e. salivation, apathy, staggering, abdominal and lateral position, atony, narcotic state and no pain reflex before death, ruffled fur and poor general condition (BASF 1978).

In a supportive gavage study in female rats (vehicle gum arabic, observation period 2 days), LD50 values were 4895 mg/kg (BASF 1957).

Further LD50 values are available as publications from secondary sources. LD50 values reported for rats were 4960 mg/kg (Jenner 1964) and 4960 mg/kg (Baer 1967).

In an acute oral toxicity study in male mice an LD50 of 1424 mg/kg has been determined (BASF 1957). Further studies, available as publications from secondary sources, do not confirm this LD50 value but reported LD50 values at approx. 2000 mg/kg bw or higher, e.g. LD50=6000 mg/kg (RTECS 1940).

Acute inhalation toxicity:

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

In a supportive study, i.e. an standardized inhalation hazard test, 12 Sprague Dawley rats each were exposed for 7 hours to an atmosphere that had been saturated with the volatile parts of the test compound (vapour) at 20°C (BASF 1978). 0/12 rats died after 7 h exposure at 20°C. No clinical signs or adverse findings in gross pathology were observed.

 

Acute dermal toxicity:

In the chosen key study, no mortality or signs of intoxication occurred in 3 male or 3 female Sprague-Dawley rats during a 14-day observation period after a single dermal treatment with 2000 mg/kg (BASF 1978). For a supporting study (Moreno 1974; data from secondary source, reliability not assignable), a dermal LD50 of 2250 mg/kg was reported in rabbits.

Justification for classification or non-classification

Acute toxicity oral: Based on the key study (BASF 1978) with a LD50 value of 6800 mg/kg in the rat as relevant species for classification, a non- classification according to the criteria laid down in 67/548/EEC and 1272/2008/EEC is warranted. According to UN-GHS, the test substance needs to be classified as acute oral toxicant (Category 5).

Acute toxicity dermal: The present data on acute dermal toxicity do not fulfill the criteria laid down in 67/548/EEC and 1272/2008/EEC, and therefore, a non-classification is warranted. According to UN-GHS, the test substance needs to be classified as acute dermal toxicant (Category 5).