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Administrative data

Description of key information

Acute oral toxicity: LD50 = 3100 mg/kg bw (Key study, eq. to OECD 401, Klimish rate 2)
Acute dermal toxicity:LD50 > 3000 mg/kg bw (Key study, eq. to OECD 402, Klimish rate 2)
Acute inhalation toxicity: LC50 > 2.12 mg/mL (measured) / 5.00 mg/L (nominal) (Key study, eq. to OECD 403, Klimish rate 2)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
3 100 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
2 120 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
3 000 mg/kg bw

Additional information

Oral route

In an acute oral toxicity study, groups of fasted Albinos rats (10 males/dose) were given a single oral dose of Hexyl cinnamic aldehyde (HCA) at doses of 1780, 2670, 4000 and 6000 mg/kg bw and observed for 14 days

Oral LD50Males = 3100 mg/kg bw (2450-3750)

Deaths in most cases occurred overnight or later and the animals appeared depressed or lethargic throughout the study. Anorexia was seen at all levels and, although the animals were not weighed at termination of study, most appeared to have lost weight. In several cases towards the end of the study, inner ear syndrome appeared but this was not thought to be a drug effect since it is not uncommon in rats. Animals dying the day of dosing went into severe depression and looked anoxic. No stimulation was seen.

Under the test conditions, HCA is not classified according to the Directive 67/548/EEC and the Regulation (EC) No. 1272/2008.

This study is considered as acceptable and satisfies the guideline requirement for an acute oral toxicity study.

 

Dermal Route

In an acute dermal toxicity study female albino rabbits were exposed to undiluted Hexyl cinnamic aldehyde (HCA) for 24 hours (area exposure of 12 cm) at doses of 1000 (1 animal), 2000 (1 animal) or 3000 (3 animals) mg/kg bw under an occlusive coverage. Animals then were observed for 7 days.

Dermal LD50Combined > 3000 mg/kg bw

No animals died at any dose level tested. Moderate erythema was seen with all compounds. All rabbits appeared normal by the end of the test period

Under the test conditions, HCA is not classified according to the Directive 67/548/EEC and Regulation (EC) No. 1272/2008.

This study is considered as acceptable and satisfies the guideline requirement for an acute dermal toxicity study.

 

Inhalation route

In a limit acute inhalation toxicity study performed similarly to the OECD test guideline No. 403, groups of young adult Sprague-Dawley rats (5/sex)were exposed by inhalation route to aerosol of Hexyl cinnamic aldehyde (HCA) for 4hours to whole body at concentration of  5.00 mg/L (nominal, corresponding to 2.12 mg/L analytical). Animals then were observed for14days.

LC50Combined > 2.12 mg/L (analytical concentration) / 5.00 mg/L (nominal concentration)

There were no mortalities under the test conditions. The only changes that were considered possibly to be attributable to treatment were a minimal loss of body weight on the days immediately following treatment and enlarged bronchial lymph nodes at the terminal kill, multiple grey-green foci on the lungs and occasional pulmonary congestion.

As the actual concentration reached was only 2.12 mg/L, it is difficult to conclude on the classification of HCA. However it is mentioned in the OECD Guideline No. 403 (2009) that "when testing aerosol the primary goal should to be achieve a respirable particle size and this is possible with most test article at a concentration of 2.00 mg/L". Moreover, there was no mortality and observed lessions were considered by the study authors to be spontaneous and caused as a result of a mild infection with murine respiratory mycoplasmosis. Pulmonary edema and mild congestion revealed in some rats could be attributed to euthanasia. Testicular tubular degeneration and hydrometra in some rats were also considered incidental by the study authors.

Based on the above discussion, under the test conditions, HCA is not classified according to the Directive 67/548/EEC and Regulation (EC) No. 1272/2008.

This study is considered as acceptable and satisfies the guideline requirement for an acute inhalation toxicity study.

 

 

 

Justification for classification or non-classification

Harmonized classification:

No harmonized classification is available according to the Regulation (EC) No 1272/2008 including ATP1.

Self-classification:

Data are considered adequate for the purpose of classification and labelling. Based on the available data, HCA is not classified for acute toxicity.