Registration Dossier

Administrative data

Endpoint:
chronic toxicity: other route
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 2f: Acceptable calculation method

Data source

Reference
Reference Type:
publication
Title:
Study of the Biological Effects of benzoyl Peroxide
Author:
Sharratt, M., Frazer, A.C. and Forbes, O.C.
Year:
1964
Bibliographic source:
Fd. Cosmet.|Toxicol., Vol.2, 527 ~ 538, 1964

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Dibenzoyl peroxide
EC Number:
202-327-6
EC Name:
Dibenzoyl peroxide
Cas Number:
94-36-0
Molecular formula:
C14H10O4
IUPAC Name:
benzoyl benzenecarboperoxoate
Details on test material:
Novaldelox (commercial powder containing 18 percent Benzoyl peroxide)

Test animals

Species:
other: rat and mouse
Strain:
other: Albino
Sex:
male/female

Administration / exposure

Route of administration:
other: dermal (subcuaneous injection, skin painting)

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

NOEL: 2.8 ppm
LOEL: N/A

The rats consuming the flour diets containing the two
highest levels of benzoyl peroxide showed significant
decrease in body wt. gain. There were no significant
differences in the body weight of the rats given treated
breadcrumbs. There was no significant difference between
experimental and appropriate control groups in the mortality
rate of the animals except F2, in which there was a large
number of accidental deaths. There were statistically
significant incidence of atrophy of the testicles in the
rats given the diet based on flour treated with benzoyl
peroxide at 2826 ppm and in the rats receiving diets of
breadcrumbs made with flour treated with benzoyl peroxide at
28.26 and 2.826 ppm.

Pathological finding in rats
Infective F1 F2 F3 FC B1 B2 BC
Degenerative 138 109 136 159 110 130 104
Vascular including 53 62 49 48 49 49 56
haemorrhage 16 13 15 28 27 23 49
Miscellaneous 38 30 32 41 41 47 34
Tumor (ben., mal.) 12 2 3 9 31 11 35
Ulceration of 2.2 - - - 1.5 2.1 -
stomach
Atrophy of testes 27* 15 15 4 19* 23* 11

* Significant difference from controls P < 0.05
The authors suggested that this atrophy was caused by
benzoyl peroxide, which probably marginally decreased the
amount of vitamin E in the diet.

Applicant's summary and conclusion

Conclusions:
The injection of benzoyl peroxide subcutaneously in rats and mice did not result in any tumor formation at the site of injection, or in any increase in tumor incidence elsewhere. Application of a paste made from flour treated with benzoyl peroxide to the skin of rats and mice also caused no tumor formation.