Vanillin

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:

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

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

Test material information

Constituent 1

Reference substance name:

Vanillin

EC Number:

204-465-2

EC Name:

Vanillin

Cas Number:

121-33-5

Molecular formula:

C8H8O3

IUPAC Name:

1-butoxypropan-2-ol

Test animals

Species:

mouse

Strain:

other: OF1

Sex:

female

Details on test animals or test system 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:

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.