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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:
supporting study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Qualifier:
according to guideline
Guideline:
EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(7-ethyl-1H-indol-3-yl)ethanol
EC Number:
431-020-1
EC Name:
2-(7-ethyl-1H-indol-3-yl)ethanol
Cas Number:
41340-36-7
Molecular formula:
C12H15NO
IUPAC Name:
2-(7-ethyl-1H-indol-3-yl)ethan-1-ol

Test animals

Species:
mouse
Strain:
NMRI

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
polyethylene glycol 400 (PEG 400)
No. of animals per sex per dose:
Male: 437.5 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 875 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 1750 mg/kg; No. of animals: 4; Sacrifice time: 24 hours
Male: 1750 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Female: 437.5 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 875 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 1750 mg/kg; No. of animals: 4; Sacrifice times: 24 hours
Female: 1750 mg/kg; No. of animals: 5; Sacrifice times: 48 hours

Results and discussion

Test results
Sex:
not specified
Genotoxicity:
negative
Toxicity:
yes
Remarks:
(Doses producing toxicity: 1750 and 2000 mg/kg The maximum tolerated dose (= dose that causes toxic reactions without having major effects on survival within 48 hours) was determined to be 1750 mg/kg.)

Any other information on results incl. tables

Observations: As estimated by a pre-experiment, 1750 mg 7-ethyltryptophol/kg b.w. was close to th maximum tolerated dose. In the micronucleus assay 6 out of 24 animals treated with 1750 mg/kg b.w. of the test item died. The mean number of normochromatic erythrocytes was dose-dependently increased after treatment with the test item as compared to the mean value of NCEs of the vehicle control indicating that 7-ethyltryptophol had cytotoxic properties in the bone marrow. The effect was maximum pronounced in the test item group 1750 mg/kg b.w. at preparation interval 48 hours. In comparison to the corresponding vehicle controls there was no enhancement in the frequency of the detected micronuclei at any preparation interval and dose level after administration of the test item. The mean values of micronuclei observed after treatment with 7-ethyltryptophol were below the value of the vehicle control group. 40 mg/kf b.w. cyclophosphamide administered per os was used as positive control which showed a statistically significant increase of induced micronucleus frequency.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative