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EC number: 227-813-5
CAS number: 5989-27-5
In a 13-week subchronic toxicity study
performed similarly to OECD Guideline 408 and in compliance with GLP,
d-limonene was administered through gavage to groups of 10 B6C3F1
mice/sex/dose mixed in corn oil at dose levels of 0, 125, 250, 500, 1000
or 2000 mg/kg bw/day for 13 weeks (5 days/week). Animals were observed
twice daily for clinical signs of toxicity and bodyweights were recorded
Necropsy performed on all animals and
microscopic examination of specified tissues was performed for all
control and high dose animals scheduled to be killed at the end of the
One of 10 males and 2/10 females that
received 2000 mg/kg bw/day and 1/10 females that received 500 mg/kg
bw/day died before the end of the studies. Several animals in other
groups died as a result of gavage error. Clinical signs of rough hair
coats and decreased activity were observed at the two highest doses.
Final mean bodyweights of mice that received 1000 or 2000 mg/kg bw/day
were 10% lower than
that of the vehicle controls for males and
2% lower for females. An alveolar cell adenoma was observed in the lung
of 1/10 females that received 2000 mg/kg bw/day.
Therefore, the NOAEL was considered to be
500 mg/kg bw/day. The LOAEL was considered to be 1000 mg/kg bw/day for
both female and male mice, based on observation of clinical signs in
both sexes and decreased bodyweights in males. No effects in
reproductive organs were observed at either the macroscopic or the
microscopic levels therefore no effects on reproductive performance are
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