Registration Dossier
Registration Dossier
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EC number: 203-786-5 | CAS number: 110-63-4
Carcinogenicity
Administrative data
Description of key information
No carcinogenicity studies/data are available for 1,4-Butanediol, instead, key information is based on carcinogenicity studies with the analogue γ-Butyrolactone (CASRN: 96-48-0). There is no carcinogenic potential for 1,4 -Butanediol.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- There was no evidence of carcinogenic activity of γ-butyrolactone in male and female rats.
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 findings of carcinogenicity studies with the analogue γ-Butyrolactone, 1,4 -butanediol should not be categorized for carcinogenicity under the EU CLP classification system (EU Regulation 1272/2008).
Additional information
No carcinogenicity studies/data are available for 1,4-Butanediol. However, the carcinogenicity of γ-Butyrolactone (CASRN: 96-48-0), which like 1,4-butanediol rapidly metabolizes to gamma-hydroxybutyric acid (NTP, 1996), has been studied in male and female F344/N rats and B6C3F1 mice (NTP, 1992). Doses between 0 - 525 mg/kg were used. It was concluded, that there was no evidence of carcinogenic activity of γ-butyrolactone in male rats given 112 or 225 mg/kg or in female rats given 225 or 450 mg/kg in corn oil. There was equivocal evidence of carcinogenic activity of γ-Butyrolactone in male mice based on marginally increased incidences of adrenal medulla pheochromocytomas and hyperplasia in the low-dose group. The sensitivity of the study in male mice to detect a carcinogenic effect was reduced by the low survival of the high-dose group associated with fighting. There was no evidence of carcinogenic activity of γ-Butyrolactone in female mice given 262 or 525 mg/kg in corn oil.
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