Registration Dossier
Registration Dossier
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EC number: 272-810-4 | CAS number: 68915-38-8
Carcinogenicity
Administrative data
Description of key information
The analog read-across substance, adipic acid, was not carcinogenic in a limited two-years feeding study where male rats were fed with up to 5% (3750 mg/kg bw/day) adipic acid and female rats with 1% (750 mg/kg bw/day).
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 750 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Justification for classification or non-classification
The analog read-across substance, adipic acid, is not carcinogenic; no classification is required according to the EU classification criteria 67/548/EWG and regulation no. 1272/2008 (GHS).
Additional information
There are no carcinogenicity data available on Cyclohexane, oxidized, aquous extract (COP Acid).
Read Across (Adipic Acid):
Hazards identified by OECD/ICCA high production volume chemicals program in 2004:
"Adipic acid was not carcinogenic in the previously described two-years feeding study (see chapter 3.1.5: Repeated Dose Toxicity) where groups of twenty male rats were dosed with food containing 0, 0.1, 1, 3 and 5 % adipic acid (approx. 0, 75, 750, 2250, 3750 mg/kg bw/day), and female rats were dosed with 0 (n=10) and 1% (n=19) adipic acid (approx. 0, 750, mg/kg bw/day), respectively. Animals that died during the study and survivors were analyzed for incidences of tumor growth and lung pathology. The incidences of tumors observed in the adipic acid treated groups were as frequent as in the control groups (Horn et al. 1957). The study does not fully comply with the guidelines for carcinogenicity studies because the number of animals used was low, microscopic examination of only 15 tissues was done only on a representative number of animals for each group, only one concentration was tested for females, the MTD for females was not reached, and the purity of adipic acid is not indicated."
Updated relevant information:
None
Justification for selection of carcinogenicity via oral route endpoint:
Reliable read-across to analog substance (adipic acid).
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