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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
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: publication with limited documentation; no GLP; TS purity not specified;

Data source

Reference
Reference Type:
publication
Title:
STUDY OF ARTIFICIAL FLAVOURING SUBSTANCES FOR MUTAGENICITY IN THE SALMONELLA/MICROSOME, BASC AND MICRONUCLEUS TESTS
Author:
D.WILD; M.-T. KING; E . GOCKE and K. ECKHARDT
Year:
1983
Bibliographic source:
Fd Chem. Toxic.; Vol 21 , No 6, pp. 707-719

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
yes
Remarks:
limited documentation
GLP compliance:
no
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 4-Ethoxybenzaldehyde
No further data.

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 10-14 weeks

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
- Vehicle(s)/solvent(s) used: olive oil
Duration of treatment / exposure:
30 hours
Frequency of treatment:
2 applications (0, 24hours)
Post exposure period:
not applicable
Doses / concentrations
Remarks:
Doses / Concentrations:
335; 670; 1005 mg/kg bw
Basis:

No. of animals per sex per dose:
4 (sex not specified)
Control animals:
yes
Positive control(s):
No data

Examinations

Tissues and cell types examined:
bone marrow
Details of tissue and slide preparation:
No details given
Evaluation criteria:
No details given
Statistics:
No details given

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Vehicle controls validity:
valid
Negative controls validity:
not specified
Positive controls validity:
not specified

Any other information on results incl. tables

Results of micronucleus test on mouse bone marrow

 Dose [mg/kg bw]  Surviving/treated mice  Mean no. of MNPE / 1000 PE
 1005  2/4  2.9
 670  4/4  1.8
 335  4/4  2.0
 0  4/4  1.9

Applicant's summary and conclusion