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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Study well described, and meets generally the strandard guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Study done according to NTP standard protocols
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
3-ethoxy-4-hydroxybenzaldehyde
EC Number:
204-464-7
EC Name:
3-ethoxy-4-hydroxybenzaldehyde
Cas Number:
121-32-4
Molecular formula:
C9H10O3
IUPAC Name:
3-ethoxy-4-hydroxybenzaldehyde
Details on test material:
no data

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male
Details on test animals or test system and environmental conditions:
No more information on animals. No data on environmental conditions.

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
- Vehicle(s)/solvent(s) used: corn oil
- Justification for choice of solvent/vehicle: no data
- Concentration of test material in vehicle: no data
Duration of treatment / exposure:
72 hours
Frequency of treatment:
Daily during 3 days
Post exposure period:
24 hours after last dosing.
Doses / concentrations
Remarks:
Doses / Concentrations:
0; 47; 94; 187; 375; 750 mg/kg in corn oil
Basis:
nominal conc.
No. of animals per sex per dose:
5 males per dose
Control animals:
yes, concurrent no treatment
Positive control(s):
none

Examinations

Tissues and cell types examined:
bone marrow
Details of tissue and slide preparation:
CRITERIA FOR DOSE SELECTION: Doses extend up to the maximum tolerated dose.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): Based on the cell cycle and maturation times of the erythrocytes, harvesting of the bone marrow usually occurs 24 hours after the last dosing; this interval is indicated in the data tables as "sample collection time."

DETAILS OF SLIDE PREPARATION: The bone marrow is flushed from the femurs and spread onto slides. The slides are air-dried, fixed, and stained with a fluorescent DNA-specific stain that easily illuminates any micronuclei that may be present.

METHOD OF ANALYSIS: no data
Evaluation criteria:
Typically, 2000 polychromatic erythrocytes (PCEs, reticulocytes; immature erythrocytes) are scored per animal for frequency of micronucleated cells in each of 5 animals per dose group. In addition, the percentage of PCEs among the total erythrocyte population in the bone marrow is scored for each dose group as an indicator of chemical-induced toxicity. In non-treated healthy mice and rats, the %PCE in bone marrow is usually around 50-60%. If a chemical interferes with the production of erythrocytes in the bone marrow, then the %PCE in the bone marrow may decline from the typical normal level. Conversely, if erythrocyte production is stimulated by chemical exposure, then a higher percentage of immature erythrocytes may be observed.
Statistics:
no data

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified

Applicant's summary and conclusion

Conclusions:
negative
Executive summary:

In the NTP report (1984), male mice (5 per dose) were exposed by i.p. route to ethylvanillin at doses 0; 47; 94; 187; 375; 750 mg/kg in corn oil for 72 hours. 2000 polychromatic erythrocytes were scored per animal for frequency of micronucleated cells.

Negative result was reported.