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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: Documentation sufficient for assessment, method generally accepted. Purity of test substance not mentioned.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1991
Reference Type:
publication
Title:
Unnamed
Year:
1995

Materials and methods

Principles of method if other than guideline:
Monolayers of cultured Balb/c 3T3 fibroblast cells were used to study the inhibitory effects of resin composite components on DNA synthesis, total protein content, and protein synthesis, and to determine whether effects were reversible when components were withdrawn from the medium. After the substance has been dissolved in DMSO (final concentration of DMSO was 0.1%) visible and UV spectra were determined on various stock concentrations in DMSO and of dilutions of 1:1000 in water. The substance was added 24 hours after the cells were plated (t=0), and were assessed at 8 and 24 hours. Reversibility was determined by removal of the medium for selected wells and its replacement with fresh medium for an additional 24 hours. The ID10 (the earliest measure of cytotoxic effects) and ID50 values (effective doses which decreased number of viable cells to 10%/50 % of the control assay) were calculated of the particular metabolic process as well as the range of concentrations over which cell metabolism was irreversibly inhibited.
GLP compliance:
not specified
Type of method:
in vitro

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Substance: 1,6-Hexane diol dimethacrylate (HDDM)
- Purity: not specified, but commercial grade assumed
- Supplier: Esschem (Essington, PA, USA) (information of Jontell M et al., 1995)
- Lot/batch No.: 887-315-2

Administration / exposure

Details on exposure:
6 replicate wells were used for each concentration.

Results and discussion

Details on results:
The ID50 values for all three metabolic parameters and for the ranges of irreversibility were of the same magnitude. The ID50 for DNA and protein synthesis and the range of irreversibility in the presence of 1,6-Hexanedioldimethacrylate (HDDM) ranged between 10 and 100 µmol/L. There was no upper limit of the irreversibility range for HDDM because irreversible effects were not observed with this substance. The ID10 the earliest measure of cytotoxic effects was the most variable parameter.
For HDDM the ID10 for protein synthesis was up to one order of magnitude less than that for DNA synthesis. It was impossible to determine the exact concentration at which cytotoxic effects were initiated and which concentration was associated with cell death.

Any other information on results incl. tables

Results for 1,6 -Hexanediol dimethacrylate:

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ID50: 28 µmol/L (Balb/c 3T3 DNA synthesis 45-minute pulse (cited in Jontell M et al., 1995))

ID50: 32 µmol/L (Balb/c 3T3 24 -hour protein synthesis 45-minute pulse (cited in Jontell M et al., 1995))

Applicant's summary and conclusion

Conclusions:
For 1,6-Hexanedioldimethacrylate (HDDM) the ID50 values for DNA and protein synthesis at 24 hours were similar in magnitude. HDDM fell in the range of 10 - 100 µmol/L, indicating that it was slightly less cytotoxic.