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Description of key information

NOEL (s.c., every 2 weeks for 16 injections, mouse): 2.5 mg/mouse (highest dose tested)
NOEL (s.c., twice weekly, 52 weeks, rat): 3.5 mg/bw/application (highest dose tested)
NOEL (s.c, co-carcinogenic properties, mouse): 2.5 mg/mouse (highest dose tested)

Key value for chemical safety assessment

Justification for classification or non-classification

Methylparaben does not have to be classified for carcinogenicity according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC) because in several carcinogenicity studies performed with rats and mice it did not show any carcinogenic effect and has no genotoxic properties.

Additional information

Several carcinogenicity studies were performed with Methylparaben:

- Swiss and Balb/c weanlings and Fischer 344 rats were injected either subcutaneously or intraperitoneally every 2 weeks for 15 to 16 injections and observed for 18 months. A similar group of mice was given a single inoculation of Methylparaben as control. While positive controls (Dibenzpyrene and 1,2,5,6-Dibenzanthracene) showed a significant increase in tumor incidence, no increased incidence in number of tumors in rats as well as in mice occurred (highest dose: 2.5 mg/mouse, 3.5 mg/kg bw/application (rat)).

- To determine the carcinogenic potential of Methylparaben the substance was injected to F344 Fischer rats twice weekly at different dosages for 1 year. Each animal was sacrificed and autopsied at 12 or 18 months on test period. Methylparaben did not show any carcinogenic properties under the conditions described.

- Mice received s.c.injections, after 8 and 12 weeks, the injection sites were excised, pooled and homogenized. The pooled material was transferred into untreated mice, which were examined weekly for any tumor appearing. No palpable tumors were observed in the Methylparaben group.

- A/Heston Jax mice (most sensitive for lung adenomas) were injected s.c. Three to six months later the mice were killed and the adenomas on the lung surface were counted. Methylparaben was not carcinogenic for A/Jax ot CF1 mouse lungs. The low dose of 0.05 mg Dibenzpyrene (positive control) was significantly carcinogenic at the 5% probability level when tested in CF1 mice, as were the higher doses in the A/Jax mice.