Registration Dossier

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
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
yes
Remarks:
- details on housing/feeding not provided.
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): Lycasin 80/55
- Physical state: Colourless viscous liquid

Test animals

Species:
mouse
Strain:
other: - Swiss Carworth Farm Lane-Petter
Sex:
male
Details on test animals and environmental conditions:
Details were not provided. Animals weighed between 25 and 30 g and, during the test, had access to water and food.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
- Vehicle(s)/solvent(s) used: Permuted water.
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: Lycasin was diluted in permuted water at the concentration of 0.2 mL/mL for administration to the low-dose group (5 mL/kg bw); undiluted Lycasin was administered to the high-dose group (25 mL/kg bw).
Duration of treatment / exposure:
48 hours.
Frequency of treatment:
One dose/day with sacrifice occurring 6 hours after the second administration.
Post exposure period:
6 hours after the second of 2 daily doses.
Doses / concentrations
Remarks:
Doses / Concentrations:
5 and 25 mL/kg bw
Basis:
actual ingested
No. of animals per sex per dose:
10
Control animals:
yes, concurrent vehicle
Positive control(s):
Urethane
- Route of administration: Oral gavage.
- Doses / concentrations: 2 g/kg bw administered as a solution at 80 mg/mL

Examinations

Tissues and cell types examined:
Bone marrow from femurs.
Details of tissue and slide preparation:
After centrifugation, the bone marrow is homogenized and one drop is smeared on a slide. The smear is dried and coloured with May-Grunwald-Giemsa.
Evaluation criteria:
Evaluation was based on the results of the student's t-test.
Statistics:
Student's t-test.

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
yes
Remarks:
- one male in the high-dose group died after administration of the second dose. No other toxicity was reported.
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid

Any other information on results incl. tables

Products   Doses  Number of Mice  Percentage of erythrocytes with micronuclei
 Permuted water  -  10  0.10 ± 0.03
 Lycasin  5 mL/kg  10  0.12 ± 0.05
 Lycasin  25 mL/kg  9  0.15 ± 0.05
Urethane   2 g/kg  10 5.76 ± 0.75

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative