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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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is sufficiently documented and the test conditions are similar to current test guidelines (the deviations are not judged to affect the validity of the study). The study was conducted before GLP implementation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
Deviations:
yes
Remarks:
no positive control, only females were treated, sampling 6 hrs after the last exposure
GLP compliance:
no
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
other: OF1
Sex:
female
Details on test animals and environmental conditions:
- Source: IFFA CREDO
- Weight at study initiation: ca. 20 g
- Assigned to test groups randomly: yes
No more data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
- Vehicle(s):
> Vehicle(s)/solvent(s) used: arachis oil
> Amount of vehicle: 0.2 mL / 20 g
> Justification for choice of solvent/vehicle, concentration of test material in vehicle, lot/batch no, purity: data not available
Details on exposure:
no data
Duration of treatment / exposure:
at 30 hrs and at 6 hrs before bone-marrow was sampled
Frequency of treatment:
30 and 6 hours before sampling
Post exposure period:
6 hours
Doses / concentrations
Remarks:
Doses / Concentrations:
twice 500 mg/kg, twice 1000 mg/kg (in arachis oil)
Basis:
no data
No. of animals per sex per dose:
10 females per dose
Control animals:
yes, concurrent vehicle
Positive control(s):
none

Examinations

Tissues and cell types examined:
bone marrow (see table 1 in the attached document)
Details of tissue and slide preparation:
- Criteria for dose selection: a preliminary study showed 2/3 deaths at 2 g/kg, and no death at 0.25, 0.5 and 1 g/kg
- Treatment and sampling times: treatment 30 and 6 hours before sampling
- Details of slide preparation: cell suspensions were centrifugated for 5 minutes at 1000 tr/min, the supernatent discarded, cells were coloured with Giemsa
- Method of analysis: microscope (immersion) X 100
- Other: 1000 polychromatic cells were observed
Evaluation criteria:
no data
Statistics:
no data

Results and discussion

Test results
Sex:
female
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
not applicable
Additional information on results:
See detailed results in table 2

Any other information on results incl. tables

Table 2: Results of in vivo micronucleus test with Vanillin 

 

Control

Low dose

High dose

Number of cells evaluated

2000

2000

2000

Sampling time (h)

6

6

6

Number of erythro-cytes

normo­chromatic

-

-

-

poly­chromatic

-

-

-

polychromatic with micronuclei

3.8 +/- 1.9

3.5 +/- 1.6

2.9 +/- 1.2

Ratio of erythro­cytes

polychromatic / normochromatic

-

-

-

polychromatic with micro­nuclei / normochromatic

-

-

-

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Executive summary:

In a OF1 mouse bone marrow micronucleus assay (Marzin, 1979), 10 females per dose were treated by gavage with Vanillin (pure) at doses of 500 and 1000  mg/kg bw.  Bone marrow cells were harvested at 6 and 30 hours post-treatment.  The vehicle was arachid oil.

The positive control induced the appropriate response. 

There were no signs of toxicity during the study.