Registration Dossier

Toxicological information

Specific investigations: other studies

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Administrative data

Endpoint:
cytotoxicity
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Cell cultures of foetal rat-brain tissue were incubated with the chemical at 0.5, 1 and 2 mM (1 mM = 86 µg/mL) for 3 days. Cytotoxicity to neuronal and non-neuronal cells was assayed by qualitively evaluating the morphological integrity of the monolayer (e.g. cell death, depressed sprouting of neurites).
GLP compliance:
not specified
Type of method:
in vitro
Endpoint addressed:
developmental toxicity / teratogenicity

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, St. Constant, Quebec

Administration / exposure

Route of administration:
other: in vitro exposure of primary monolayers cultured from dissociated foetal rat brains
Vehicle:
other: nutrient medium
Duration of treatment / exposure:
72 h
Frequency of treatment:
continuous
Doses / concentrationsopen allclose all
Dose / conc.:
0.5 other: mM (nominal)
Dose / conc.:
1 other: mM (nominal)
Dose / conc.:
2 other: mM (nominal)

Examinations

Examinations:
Exposed cultures were examined daily for degenerative changes progressively disrupting the monolayer.

Results and discussion

Details on results:
No degenerative effect on both, neuronal and non-neuronal foetal rat-brain cells in vitro.
The idea behind this assay was testing for "neuroteratogenicpotential", primary cell cultures from foetal brain serving as surrogate of the initial targetorgans, peripheral and central nervous system.

Applicant's summary and conclusion