Registration Dossier

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Description of key information

- no carcinogenic effects | Rat (male/female) | OECD 453 | oleic acid 
- no carcinogenic effects | Rat (male/female) | OECD 451 | sodium oleate

Key value for chemical safety assessment

Justification for classification or non-classification

Since neither oleic acid nor the sodium salt of oleic acid show carcinogenic effects, a classification is not necessary.

Additional information

The chronic toxicity and carcinogenicity of sodium oleate and oleic acid were examined in Fisher 344 rats of both sexes. The rats were divided into three groups: Group I was given 5% test substance, and group II was given 2.5% test substance in their drinking water. Group III was the control group. All rats were fed this mixture for two years.

Urine alnalysis, serological and haematological tests did not reveal any significant changes in comparison to the control group.

The weight check of the organs among male rats revealed that the liver of the rats in the high concentration group weighed less than that of the controll group, and the thymus gland of the female rats was the heaviest.

In both experiments with sodium oleate and oleic acid, tumors developed in various organs. The question needs to be answered as to wether this development was caused by the substances tested or occurred spontaneously. In the case of male rats the development of tumors in this experiments occured in 96% of the high concentration group, 100% of the low concentration group and 98% of the control group, whereas in the case of female rats it occured in 56% of the high concentration group, 72% of the low concentration group and 56% of the control group.

The development of tumors shows no significantly greater incidence than the natural incidence of tumors, so that sodium oleate is not found to be carcinogenic. If we compare the individual tumors of this experiments with the naturally occuring tumors, pituritary tumors occured fairly often among male rats. Insulinoma of the spleen did not occur among the control groups, although in 8.4% there were cases of natural development, so that it can hardly be claimed that this is a tumor, which developed due to the tested substances. Among the female rats the incidence of pituitary tumors is about the same as in the case of natural development. C-cell adenoma of the thyroid gland also occured quite often, and the rate of incidence of tumors in the reproductive organs and mammary glands was about the same.

From the above results no carcinogenic effects of the long-term administration of sodium oleate and oleic acid can be detected. the tumors which developed cannot be attributed to the substances tested, but have to be considered tumors which develops naturally.