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Toxicological information

Genetic toxicity: in vivo

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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 guidelineopen allclose all
Qualifier:
according to
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
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
not specified
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
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 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 / concentrationsopen allclose all
Dose / conc.:
0 other: mg/kg
Dose / conc.:
68 other: mg/kg
Dose / conc.:
126 other: mg/kg
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.