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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
68478-10-4
Cas Number:
68478-10-4
IUPAC Name:
68478-10-4
Constituent 2
Reference substance name:
Dicyclopentadiene/Codimer Concentrate (DCPD/Codimer Concentrate)
IUPAC Name:
Dicyclopentadiene/Codimer Concentrate (DCPD/Codimer Concentrate)
Details on test material:
- Name of test material (as cited in study report): Dicyclopentadiene/Codimer Concentrate
- Synonyms: DCPD/Codimer Concentrate, DCP97, H-25430
- CA Index name: Naphtha (petroleum), light steam-cracked, debenzenized, C8-16-cycloalkadiene concentrate
- Lot number: 121302
- Substance type: a distillate from a C8+ fraction of thermally processed pyrolysis gasoline obtained from ethylene production
- Physical state: colourless liquid
- Purity: Not applicable (The test substance was within specifications and the occurrence and distribution of isomers was as expected).
- Stability under test conditions: stable at room temperature below 70°F, protected from light and air
- Composition of test material, percentage of components:
29.175 wt % endo- and exo-DCPD
18.726 wt % C4-MCPD and C5-MCPD codimers
13.210 wt % MCPD dimer
12.903 wt % CPD-MCPD codimer
8.129 wt % C8 aliphatic and aromatic hydrocarbons
7.144 wt % C4-CPD and C5-CPD codimers
3.625 wt % MCPD-C7 dimer
2.771 wt % Tetrahydroindene
1.917 wt % Trimers
0.927 wt % C7 cyclic hydrocarbon
0.697 wt % C5 acyclic hydrocarbon dimer
0.634 wt % MCPD monomer
0.078 wt % CPD monomer
0.063 wt % C6 acyclic hydrocarbons


Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9 from Aroclor induced rat liver
Test concentrations with justification for top dose:
15, 50, 150, 500, 1500 and 5000 µg per plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: ethanol
Controls
Negative solvent / vehicle controls:
yes
Remarks:
ethanol
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene, 2-nitrofluorene, sodium azide, 90aminoacridine, methyl methanesulfonate
Remarks:
+S9: All S.typh strains 1 µg/plate, E.coli 10 µg/plate. -S9: S. typh TA98 2-nitrofluorene 1 µg/plate, TA100 and TA1535 sodium azide 1 µg/plate, TA1537 9-aminoacridine 75 µg/plate, E.coli methyl methanesulfonate 1000 µg/plate
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48-72 hours

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
Evaluation criteria:
For each replicate plating, the mean and SD of the number of revertants/plate were counted. For a positive result, there must be a dose-related increase in the mean revertants/plate of at least one tester strain over a minimum of 2 increasing concentrations of test substance. Data sets for TA1535 and TA1537 were judged positive if the increase in mean revertants at the peak of the dose response ≥ 3 times the mean vehicle control value. Data sets for TA98, TA100 and WP2uvrA were positive if the increase in mean revertants at the peak of the dose response ≥ 2 times mean vehicle control value.

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
some conditions beginning at 667, 1000 or at 5000 µg/plate
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
some conditions beginning at 667, 1000 or at 5000 µg/plate
Vehicle controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results:
negative with metabolic activation
negative without metabolic activation

Dicyclopentadiene/codimer concentrate did not cause a positive response in either the presence or absence of Aroclor-induced rat liver S9.
Executive summary:

Dicyclopentadiene/codimer concentrate was tested in a bacterial reverse mutation test using Salmonella typhimurium tester strains TA98, TA100, TA1535 and TA1537 and Escherichia coli tester strain WP2 uvrA in the presence and absence or Aroclor-induced rat liver S9.

In the mutagenicity test, no positive mutagenic response was observed. The dose levels tested were 15, 15, 150, 500, 1500 and 5000 ug/plate. Toxicity was seen with some concentrations starting at 1500 or at 5000 ug/plate. No precipitate was observed.

It is concluded that dicyclopentadiene/codimer concentrate (CAS 68478-10-4) did not cause a positive response in either the presence or absence of Aroclor-induced rat liver S9 and is considered not to be mutagen in this test system.