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Description of key information

In a subacute repeated dose oral toxicity study in male Wistar rats the test animals were given a powder diet containing phthalic acid (PA) at a level of 0.5 or 5% for 34 to 36 days, respectively. PA had no effect, even at 5% concentration in the diet. Therefore the NOEL was ca. 5000 mg/kg bw (Murakami, 1986).
In another subacute oral toxicity study in male Wistar rats the test animals were fed diets containing 2% of PA for 1 week.
No relevant effects were observed in the rats treated with PA. Therefore the NOAEL was ca.2000 mg/kg bw (Oishi, 1980).
There are no subchronic or chronic studies available for PA. Due to the rapid hydrolysis of pthalic anhydride to PA a read across with phthalic acid is performed. In a 2-year repeated dose study a NOAEL 500 mg/kg/day was reported with Phthalic Anhydride, based on the reduced body-weight gain. In mice no NOAEL was identified and the LOAEL in female mice was 12,019 ppm (approx. 1717 mg/kg/bw/day) and in males 16,346 ppm (approx. 2340 mg/kg/bw/day) (Huff, 1984; Kluwe, 1986; NCI, 1979).
No repeated dose inhalation or dermal studies are available.

Key value for chemical safety assessment

Additional information

Justification for classification or non-classification

based on the available studies, the test substance needs no classification for repeated dose toxicity according to EU guidelines.