Propionic anhydride

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline without detailed documentation

Data source

Reference

Reference Type:

publication

Title:

Screening of the food additive propionic acid for genotoxic properties

Author:

Basler E.D., Hude v.d, Scheutwinkel

Year:

1987

Bibliographic source:

Food Chem. Toxicol, 25: 287-290

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Deviations:

yes

Remarks:

(only one dose group)

GLP compliance:

not specified

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

Propionic acid

EC Number:

201-176-3

EC Name:

Propionic acid

Cas Number:

79-09-4

Molecular formula:

C3H6O2

IUPAC Name:

propanoic acid

Details on test material:

- Name of test material (as cited in study report): propionic acid
- Source: E. Merck AG (Darmstadt)
- Analytical purity: 99%

Test animals

Species:

hamster, Chinese

Strain:

other: Cricetulus griseus

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: 8-12 wks (no further details on test animals)
- number of animals/dose: 6 male and 6 females


ENVIRONMENTAL CONDITIONS
- no data

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

physiol. saline

Details on exposure:

Exposure volume: 5 ml/ kg bw

Duration of treatment / exposure:

single dose injection

Frequency of treatment:

once

Post exposure period:

no

Doses / concentrations

Remarks:

Doses / Concentrations:
2,5% propionic acid/kg bw. (= 125 mg/kg)
Basis:
other: actually injected

No. of animals per sex per dose:

6/sex/dose/sacrifice time. Total = 36

Control animals:

yes

Positive control(s):

cyclophosphamide

Examinations

Tissues and cell types examined:

Bone marrow prepared according to the method of schmid (1975)

Details of tissue and slide preparation:

TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
- The animals in both control groups were killed 24 hr after injection. The hamsters treated with propionic acid were killed 12, 24 or 48 hr after treatment. Five males and five females from each group were examined.
- number of polychromatic erythrocytes scored: 5000

Evaluation criteria:

no data

Statistics:

The standard tables of Kastenbaum & Bowman (1970) were used to test for significance

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

yes

Remarks:

4/36 of mortality was observed. No further information

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): The mean percentage of micronucleated polychromatic erythrocytes was 7.9 in the positive control group and 0.13 in the hamsters treated with saline only (a significant difference, P < 0.05). The numbers of MN-PCEs in animals treated with propionic acid were not significantly different from those the control animals.
- Ratio of PCE/NCE (for Micronucleus assay): no data
- Appropriateness of dose levels and route: appropriate
- Mortality: 4 of 36 treated animals died

Any other information on results incl. tables

Table 1: Numbers of micronucleated polychromatic erythrocytes in the bone marrow cells of Chinese hamster after intraperitoneal injection of propionic acid

 

Compound	Dose/kg bw	Lenth of exposure (hr)	No./sex/	% PE with MN
Control (physiol. Saline)	5 ml	24	5F	0.14
			5M	0.12
Propionic acid	5 ml	12	5F	0.06
			5M	0.06
		24	5F	0.18
			5M	0.14
		48	5F	0.12
			5M	0.16
Cyclophosphamid	80 mg	24	5F	7.78*
			5M	8.02*

 

* values differ significantly (p< 0.05) from saline control