Registration Dossier

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: other:
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: see 'Remark'
Remarks:
It is a study that has been published in a peer reviewed journal. The restriction is due to the use of the read across approach: the test was performed not with 3-PPB but with Benzyl alcohol, a substance which has been demonstrated to be very similar in structure, physical/chemical properties and toxicological profile .

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
yes
Remarks:
only one injection given
GLP compliance:
not specified
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): benzyl alcohol
- Molecular formula (if other than submission substance): C6H5CH2OH
- Molecular weight (if other than submission substance): 108.14 g/mole

- Substance type: organic
- Physical state: Liquid
- Analytical purity:

Test animals

Species:
mouse
Strain:
other: ddY
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Shizouka Agricultural Cooperative Association of Laboratory Animals, Shizouka, Japan.
- Age at study initiation: 8 weeks
- Weight at study initiation:
- Assigned to test groups randomly: [no/yes, under following basis: ]
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
Saline
Details on exposure:
Single ip injection
Frequency of treatment:
once
Post exposure period:
24 hrs after injection the animals were sacrificed
Doses / concentrations
Remarks:
Doses / Concentrations:
50, 100, 200 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
6
Control animals:
yes, concurrent vehicle
Positive control(s):
Mitomycin C used as positive control material

Examinations

Tissues and cell types examined:
bone mallow cells
polychromatic erythrocytes( PCE)
micronucleated PCEs (MNPCEs)
Details of tissue and slide preparation:
femoral bone mallow cells were flushed out with foetal bovine serumand smeared on clean glass slides. Cells were fixed with methanol for 5 min and stained with Giemsa 1000 polychromatic erythrocytes(PCE) per mouse were scored and the mumber of micronucleated PCEs (MNPCEs) were
recorded.
the proportion of PCEs among the total erythrocytes were also evaluated
Evaluation criteria:
Before evaluating the test data statistically the frequencies of MNPCEs in concurrent negative and positive
controls were compared with the charts of our historical control data to confirm the technical validity
of the experiment
Statistics:
Monte Caarlo stimulation study

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
yes
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
No indication of micronucleus induction at dose tested

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
On the basis of the results described above, benzyl alcohol did not have any genotoxic effect in the mouse bone-marrow micronucleus test in male mice.