Registration Dossier

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Description of key information

Not a carcinogen

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Dose descriptor:
NOAEL
900 mg/kg bw/day

Additional information

The carcinogenicity of γ-Butyrolactone (GBL) 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 GBL 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 GBL 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 GBL in female mice given 262 or 525 mg/kg in corn oil. GBL is not mutagenic as determined in various in vitro and in vivo test.

.

Justification for classification or non-classification

The carcinogenicity of γ-Butyrolactone (GBL) has been studied in male and female F344/N rats and B6C3F1 mice (NTP, 1992). It was concluded, that there was no evidence of carcinogenic activity of GBL 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 GBL 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 GBL in female mice given 262 or 525 mg/kg in corn oil. GBL is not mutagenic as determined in various in vitro and in vivo test. Based on these findings, GBL should not be rated for carcinogenicity under either the EU DSD classification system (EU Directive 67/548/EEC) or the EU CLP classification system (EU Regulation 1272/2008).