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EC number: 201-506-6 | CAS number: 83-86-3
Acute Toxicity Oral (published data), rat (Fischer 344/DuCrj) m / f: LD50: 405 mg/kg bw (male); 480 mg/kg bw (female)
Acute Toxicity Oral (published data), mice (ICL-ICR) m / f: LD50: 900 mg/kg bw (male); 1150 mg/kg bw (female)
The oral LD50 values of the substance in mice (ICL-ICR) were reported to be 900 (males) and 1150 (females) mg/kg body weight (Litchfield-Wilcoxon statistics).
Most of the deaths in male mice occured within 1h after administration, whereas those in treated female mice occured between 1 and 48h after administration. Thinning of the stomach and small intestinal walls, bleeding of the glandular portion of the stomach, and hypertrophy of the gallbladder were seen in the treated animals.
Table: LD50 of fytic acid in rats
Death Time (hr.)
Slope Function (Confidence Interval at p = 0.05)
LD50 (g/kg) (Confidence Interval at p = 0.05)
1 (onset) / 3 (peak) / 63 (last)
1.684 (0.098 ~ 2.583)
2 (onset) / 2.3 (peak) / 21 (last)
1.459 (1.112 ~ 1.914)
The oral LD50 values of this test item in rats (Fischer 344/DuCrj) were reported to be 405 (males) and 480 (females) mg/kg body weight.
Most of the deaths in male and female rats occured ≤ 24 h after administration in the treated animals. Marked expansion of the stomach and bleeding of the glandular portion of the stomach were reported in treated animals.
Acute oral toxicity
The acute oral toxicity of the test item was investigated in two published scientific studies (from 1987):
A single oral administration to rats (Fischer 344/DuCrj) was followed by a 7-day observation period. Rats were dosed between 260 – 700 mg/kg body weight with in total 8 different doses. Most of the deaths in male and female rats occurred ≤ 24 h after administration in the treated animals. For male rats the onset was after 1 h, the peak of deaths was reached after 3 h and the last death occurred after 63 h. For female rats the onset was also after 2h, the peak of deaths was already reached after 2.3 h and the last death occurred after 21 h. Reported clinical signs of treated animals comprised marked expansion of the stomach and bleeding of the glandular portion of the stomach.
Result Study 1: LD50 (rat, oral): 405 mg/kg bw (male); 480 mg/kg bw (female)
A single oral administration to mice (ICL-ICR) with 10 different doses between 490 - 2500 mg/kg body weight were conducted. Most of the deaths in male mice occurred within 1h after administration, whereas those in treated female mice occurred between 1 and 48h after administration. Thinning of the stomach and small intestinal walls, bleeding of the glandular portion of the stomach, and hypertrophy of the gallbladder were seen in the treated animals.
Results Study 2: LD50 (mice, oral): 900 mg/kg bw (male); 1150 mg/kg bw (female)
Overall conclusion for acute oral toxicity:
The two reliable key studies do not contradict each other and are consistent in their results:
- Both studies result in LD50 values lower than the limit of 2000 mg/kg bw (C&L limit) and would result in a classification (Cat.4) of the substance.
- In both studies male animals were more sensitive than female animals.
- In both studies clinical signs after administration were comparable within the expected variability of different test animals (mice vs. rats). In both studies damages to the gastrointestinal tract were reported.
In conclusion, the acute oral toxiticity of the substance is considered to match the worst-case result from the more common rat model system.
LD50: 405 mg/kg bw (male); 480 mg/kg bw (female)
Acute inhalation toxicity
Not evaluated, because information not required (Regulation (EC) No. 1907/2006, Annex XII).
Acute dermal toxicity
According to the CLP Regulation (EC) No.1272/2008 Annex I: 220.127.116.11.: "Substances can be allocated to one of four hazard categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE)."
The LD50 values obtained in the acute oral toxicity studies is between > 300 - 2000 mg/kg bw and for this reason the substance is classified in Category 4 (H302) according to the CLP classification criteria.
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