Registration Dossier

Administrative data

Description of key information

National Toxicology Program (NTP), Toxicology and Carcinogenesis Studies of Phenolphthalein (CAS no. 77-09-8) in F344/N Rats and B6C3F1 Mice (Feed Studies) - Technical Report 465, 1996.
Tice, R.R., et al., Measurement of micronucleated erythrocytes and DNA damage during chronic ingestion of phenolphthalein in transgenic female mice heterozygous for the p53 gene. Environmental & Molecular Mutagenesis, 1998. 31(2): p. 113-24.
Dunnick, J.K., et al., Phenolphthalein induces thymic lymphomas accompanied by loss of the p53 wild type allele in heterozygous p53-deficient (+/-) mice. Toxicologic Pathology, 1997. 25(6): p. 533-40.

Key value for chemical safety assessment

Additional information

Phenolphthalein was tested for carcinogenicity by oral administration in two experiments in mice and in one experiment in rats [1]. In one experiment in mice, it induced histiocytic sarcomas and lymphomas in both males and females and benign ovarian tumours in females.

In an experiment in mice lacking one allele of the p53 tumour suppressor gene, it increased the incidence of lymphomas. This result was confirmed in a separate study reported as an abstract. It induced benign renal tumours in male rats and benign phaeochromocytomas in males and females [2, 3].

References

1. National Toxicology Program (NTP), Toxicology and Carcinogenesis Studies of Phenolphthalein (CAS no. 77-09-8) in F344/N Rats and B6C3F1 Mice (Feed Studies) - Technical Report 465, 1996.

2. Tice, R.R., et al., Measurement of micronucleated erythrocytes and DNA damage during chronic ingestion of phenolphthalein in transgenic female mice heterozygous for the p53 gene. Environmental & Molecular Mutagenesis, 1998. 31(2): p. 113-24.

3. Dunnick, J.K., et al., Phenolphthalein induces thymic lymphomas accompanied by loss of the p53 wild type allele in heterozygous p53-deficient (+/-) mice. Toxicologic Pathology, 1997. 25(6): p. 533-40.

Justification for classification or non-classification

Provided references on animal studies with Phenolphthalein did show sufficient evidence for the carcinogenicity in animals. There is inadequate evidence in humans for the carcinogenicity of phenolphthalein. These data justify the current legal classification for carcinogenicity Cat 2 according to the criteria outlined in 1272/2008/EC (CLP/EU-GHS).