Pyrogallol

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Mutagenicity of cosmetics ingredients licensed by the European Communities

Author:

Gocke E., King M. T., Eckhardt K. and Wild D.

Year:

1981

Bibliographic source:

Mutation Research. 1981 (90): 91-109

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: The micronucleus test was performed according to Schmid

Version / remarks:

Schmid, W., The mlcronucleus test for cytogenetic analysis, in: A. Hollaender (Ed.), Chemical
Mutagens, Vol. 4, Plenum, New York, 1976, pp. 31-53.

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Deviations:

not specified

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Pyrogallol

EC Number:

201-762-9

EC Name:

Pyrogallol

Cas Number:

87-66-1

Molecular formula:

C6H6O3

IUPAC Name:

benzene-1,2,3-triol

impurity 1

Reference substance name:

unknown impurities

IUPAC Name:

unknown impurities

Test material form:

not specified

Details on test material:

not specified

Specific details on test material used for the study:

- Source and lot/batch No.of test material:
pyrogallol was obtained from Merck Co., Darmstadt (Germany);
- Expiration date of the lot/batch:
not specified
- Purity test date: not specified

RADIOLABELLING INFORMATION (if applicable)
not applicable
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
not specified
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle:
not specified
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
not specified

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
not specified
- Preliminary purification step (if any):
not specified
- Final dilution of a dissolved solid, stock liquid or gel:
not specified
- Final preparation of a solid:
not specified

FORM AS APPLIED IN THE TEST (if different from that of starting material)
not specified

TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)
not applicable

OTHER SPECIFICS: not specified

Test animals

Species:

mouse

Strain:

NMRI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: obtained from S. Ivanovas GmbH and Co., Kisslegg/Allgau (Germany),
- Age at study initiation: not specified
- Weight at study initiation: not specified
- Assigned to test groups randomly: [no/yes, under following basis: ] not specified
- Fasting period before study: not specified
- Housing: not specified
- Diet (e.g. ad libitum): standard chow (Altromin GmbH, Lage, Germany)
- Water (e.g. ad libitum): water ad libitum.
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified

IN-LIFE DATES: From: To: not specified

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

not specified

Details on exposure:

not specified

Duration of treatment / exposure:

The animals were treated at 0 and 24 h, and bone-marrow smears were prepared at 30 h.

Frequency of treatment:

not specified

Post exposure period:

not specified

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

0 other: mg/kg

Doses / concentrations 2

Dose / conc.:

68 other: mg/kg

Doses / concentrations 3

Dose / conc.:

126 other: mg/kg

Doses / concentrations 4

Dose / conc.:

252 other: mg/kg

No. of animals per sex per dose:

4 mice (2 male, 2 female) were used for each of 3 doses

Control animals:

yes

Positive control(s):

not specified

Examinations

Tissues and cell types examined:

- N. Surviving/N.treated mice
- Micronucleated PE (%.)

Details of tissue and slide preparation:

Slides were coded, and 1000 polychromatic erythrocytes were scored per mouse.

Statistics:

Significance was calculated according to the Kastenbaum-Bowman tables (P<0.01)

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

positive

Remarks:

Significantly different from control @ 126 and 252 mg/kg

Toxicity:

not specified

Vehicle controls validity:

not specified

Negative controls validity:

not specified

Positive controls validity:

not specified

Applicant's summary and conclusion

Conclusions:

In the mouse micronucleus test, up to 252 mg/kg pyrogallol was administered (i.p.) to four mice at 0 and 24 hours. An untreated group of four mice served as the control. Bone marrow smears were prepared at 30 hours. Pyrogallol significantly increased the percentage of micronucleated polychromatic erythrocytes.