Registration Dossier
Registration Dossier
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EC number: 246-770-3 | CAS number: 25265-71-8
Carcinogenicity
Administrative data
Description of key information
Based on the available 2-year drinking water study with rats and mice, dipropylene glycol is considered to be non-carcinogenic.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 2 330 mg/kg bw/day
- Study duration:
- chronic
- Quality of whole database:
- Studies available in both rat and mice
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the absence of neoplastic lesions in the available 2 -year drinking water study with rats and mice, classification of dipropylene glycol for carcinogenicity is not warranted in accordance with Directive 67/548/EEC and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Additional information
An NTP 2-year drinking water study with rats and mice was available for assessment (National Toxicology Program, 2004). In the rat study, the exposure concentrations for the 2-year drinking water study were 0, 2,500, 10,000, and 40,000 ppm, corresponding to actual average ingested doses of 115 , 470 and 3040 mg/kg bw/day in males and 140, 530 and 2330 mg/kg bw/day in females. In the study with mice, the used exposure levels were 0, 10000, 20000 and 40000 ppm, corresponding to average ingested doses of 735, 1220 and 2390 mg/kg bw/day (males) and 575, 1040 and 1950 mg/kg bw/day (females). In the rat study, dipropylene glycol-related non-neoplastic lesions were found in the kidney, liver, and nose (see Section on repeated dose toxicity for more details). In the mice study, no compound-related neoplasms or non-neoplastic lesions were observed; only the reduced body weights (see Section repeated dose toxicity for further details). In conclusion, no evidence of carcinogenic activity of dipropylene glycol was observed in either rats or mice in the 2 -year drinking water study.
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