(R)-10-β-D-glucopyranosyl-1,8-dihydroxy-3-(hydroxymethyl)anthracen-9(10H)-one

Carcinogenicity

Administrative data

Endpoint:

carcinogenicity: oral

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test performed on the whole leaf extract of Aloe barbadensis Miller [Aloe vera]

Remarks:

aloin is a constituent of the whole leaf extract of Aloe barbadensis Miller [Aloe vera]

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Materials and methods

GLP compliance:

yes

Test material

Test material information

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Details on test animals or test system and environmental conditions:

48 male and 48 female F344/N

Administration / exposure

Route of administration:

oral: drinking water

Vehicle:

water

Details on exposure:

drinking-water containing whole leaf extract of Aloe barbadensis Miller [Aloe vera] at 0 (controls), 0.5%, 1.0%, or 1.5% (wt/wt)

Duration of treatment / exposure:

2 years

Control animals:

yes

Applicant's summary and conclusion

Conclusions:

In a 2-year study of carcinogenicity, groups of 48 male and 48 female F344/N rats were given drinking-water containing whole leaf extract of Aloe barbadensis Miller [Aloe vera] at 0 (controls), 0.5%, 1.0%, or 1.5% (wt/wt) for 104 weeks. The average content of aloin A and aloe-emodin of the whole leaf test material was 6.40 and 0.071 mg/g, respectively. The doses of whole leaf extract were equivalent to average daily doses of approximately 0, 0.2, 0.6, or 1.1 g/kg bw in males and 0, 0.3, 0.7, or 1.3 g/kg bw in females. Survival of exposed groups was similar to that of controls. Whole leaf extract caused increased incidences of adenoma and carcinoma of the large intestine (colon and caecum) in males and females. Other treatment-related lesions included hyperplasia and/or inflammation in the mesenteric lymph node, forestomach, small intestine, and large intestine in males and females.