Benzene-1,2:4,5-tetracarboxylic dianhydride

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

fish, juvenile growth test

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
As the substance to be registered, PMDA, is unstable in water (t1/2 approx. 20 min), the corresponding hydrolysis product Pyromellitic acid (PMA) was tested.
The test item PMA was found to be non-toxic in the acute fish toxicity study over 96 hours. Neither mortality nor clinical symptoms were observed in the acute test, the 96h LC50 and NOEC were found > 100 mg/l and 100 mg/l respectively.
In addition, an early life stage study on the analog, phthalic anhydride (CASRN 85-44-9) was performed. The concentration calcuated to cause embryotoxicity (lethality & malformations) in 50% of zebrafish following 7 d exposure is 561 mg/L (nominal). The LC50 is clearly above 100 mg/l at 560 mg/L.
Therefore, a long-term toxicity study on fish for PMDA/PMA is scientifically not necessary.

Description of key information

The test item was found to be non-toxic in the acute fish toxicity study over 96 hours. Neither mortality nor clinical symptoms were observed in the acute test, the 96h LC50 and NOEC were found > 100 mg/l and 100 mg/l respectively. A long-term toxicity study (ealry life stage test) on the analog phthalic anhydride did not cause severe effects up to 100 mg/l, the calculated LC50 was found to be 560 mg/l. Therefore, a long-term toxicity study on fish on PMDA/PMA is scientifically not necessary.