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Toxicological information

Toxicity to reproduction: other studies

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Administrative data

Endpoint:
toxicity to reproduction: other studies
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP. Reliability is assessed in the Risk Assessment Report under the Existing Substances Regulation.

Data source

Reference
Reference Type:
publication
Title:
Estrogenic activity of musk fragrances by the E-screen assay using human mcf-cells.
Author:
Bitsch, N., Dudas, C., Korner, W., Failing, K., Biselli, S., Rimkus, G., Brunn, H.
Year:
2002
Bibliographic source:
Arch Environ Contam Toxicol. 43(3), 257-64

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
according to the method for the E-screen assay of Soto et al. (1995).
GLP compliance:
no
Type of method:
in vitro

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
HHCB (purity 98%) in ethanol (10 mmole/L)

Administration / exposure

Vehicle:
ethanol
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
6 days
Duration of test:
6 days
Doses / concentrations
Remarks:
Doses / Concentrations:
5 different concentrations, the highest being 10 μM with a solvent concentration of 0.1% at the highest.
Basis:

Results and discussion

Any other information on results incl. tables

HHCB showed a slightly higher but statistically insignificant rate of proliferation relative to the hormone-free control

Applicant's summary and conclusion

Conclusions:
HHCB showed a slightly higher but statistically insignificant rate of proliferation relative to the hormone-free control
Executive summary:

In a non-GLP study, HHCB (purity 98%) in ethanol (10 mmole/L) was added to estrogen receptor-positive human mammary carcinoma cells (MCF-7) and incubated for 6 days according to the method for the E-screen assay of Soto et al. (1995). It was tested at 5 different concentrations, the highest being 10 μM with a solvent concentration of 0.1% at the highest. The rate of proliferation of the cells was compared to that of a hormone-free control sample as determined by photometric analysis of the total protein content of the fixed cells. The relative rate of proliferation (test substance relative to control) was then compared to that of 17β-estradiol. HHCB showed a slightly higher but statistically insignificant rate of proliferation relative to the hormone-free control