Registration Dossier
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EC number: 204-171-4 | CAS number: 117-08-8
Endpoint summary
Administrative data
Description of key information
In a NTP report two oral subchronic studies in rats and mice are
reported (NTP Technical Report on Toxicity Studies of
Tetrachlorophthalic Anhydride (CAS No. 117-08-8). The substance was
administered by gavage to F344/N Rats and B6C3F1 Mice. In rats the no
observed adverse effect level was < 94 mg/kg bw (lowest applied dose).
Evidence of organ toxicity was limited to the kidneys of rats. Male and
female rats exhibited dose dependent increases in kidney weights and in
the incidence and severity of renal tubule necrosis and/or dilation. No
significant adverse effects were seen in mice given doses as high as
1500 mg/kg per day for 13 weeks.
Additionally 2 inhalative subchronic studies are available as secondary
literature. Groups of male and 15 female rats were exposed to
atmospheric dust or fume levels targeted at 0, 0.5, 5 and 50 mg/m3 for 6
hr/d, 5d/week for 13 weeks.
Key value for chemical safety assessment
Additional information
A NTP Technical Report on Toxicity Studies of Tetrachlorophthalic Anhydride (CAS No. 117-08-8) is available. The substance was administered by Gavage to F344/N Rats and B6C3F1 Mice. In rats the no observed adverse effect level was < 94 mg/kg bw (lowest applied dose).
Evidence of organ toxicity was limited to the kidney of rats. Male and female rats exhibited dose dependent increases in kidney weights and in the incidence and severity of renal tubule necrosis and/or dilation.
No significant adverse effects were seen in mice given doses as high as 1500 mg/kg per day for 13 weeks.
Groups of 10 rats and 10 mice of each sex received TCPA in corn oil vehicle by oral gavage (5 days/week) at doses of 0, 94, 187, 375, 750, and 1500 mg/kg. Clear evidence of organ toxicity following administration of TCPA in corn oil by gavage for 13 weeks was limited to the kidney of rats. The no-observed-adverse effect level for histopatholologic lesions in this tissue was not achieved with doses as low as 94 mg/kg per day. No significant adverse effects were seen in mice given doses as high as 1500 mg/kg per day for 13 weeks.
In the subchronic inhalation studies the only gross pathological observation attributable to treatment was the appearance of petechial hemorrhages in the lungs of several treated rats. Histopathological changes in the lungs were also noted in all dose groups. Irregular thickening of the alveolar septa, scattered pigmented macrophages and multinucleate giant cells, multifocal accumulation of alveolar macrophages and multifocal alveolar hemorrhages were noted.
Justification for classification or non-classification
Based on the results of the subchronic oral and inhalative repeated dose studies a classification is not justified.
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