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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978-10-23 1979-01-17
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
3-[[2-[2-[2-[2-(3-carboxy-2,4,6-triiodoanilino)-2-oxoethoxy]ethoxy]ethoxy]acetyl]amino]-2,4,6-triiodobenzoic acid;(2R,3R,4R,5S)-6-(methylamino)hexane-1,2,3,4,5-pentol
Cas Number:
68890-05-1
Molecular formula:
C29H35I6N3O14
IUPAC Name:
3-[[2-[2-[2-[2-(3-carboxy-2,4,6-triiodoanilino)-2-oxoethoxy]ethoxy]ethoxy]acetyl]amino]-2,4,6-triiodobenzoic acid;(2R,3R,4R,5S)-6-(methylamino)hexane-1,2,3,4,5-pentol
Specific details on test material used for the study:
- Name used in the test report: Biliscopin minor
- Physical appearance: Clear colorless liquid

Method

Target gene:
Histidine locus
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium, other: TA1535, TA1537, TA1538, TA98 and TA100
Details on mammalian cell type (if applicable):
MEDIA USED
- Type and identity of media used: Selective agar plates
Species / strain / cell type:
Saccharomyces cerevisiae
Remarks:
D4
Details on mammalian cell type (if applicable):
MEDIA USED
- Type and identity of media used: Selective agar plates
Metabolic activation:
with and without
Metabolic activation system:
S9 homogenate
Test concentrations with justification for top dose:
1, 5, 10, 50, 100 and 500 µL
Vehicle / solvent:
DMSO
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
DMSO (50 µL / plate)
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: N-METHYL,N-NITRO,N—NITROSOGUANIDINE
Remarks:
-S9: TA1535, TA100, D4,10 µg / plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
DMSO (50 µL / plate)
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
-S9, TA1537, 50 µg / plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
DMSO (50 µL / plate)
True negative controls:
no
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
-S9, TA1538, TA98, 10 µg / plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
DMSO (50 µL / plate)
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-anthramine
Remarks:
+S9: TA1535, TA1537, TA1538, TA98, TA100, D4, 2.5 µg / plate
Details on test system and experimental conditions:
METHOD OF APPLICATION:
- Plate Test: Agar Incorporation: Approximately l08 cells from an overnight culture of each indicator strain were added to separate test tubes containing 2.0 ml molten nagar supplemented with biotin and a trace of histidine. For nonactivation tests, at least 4 dose levels of the test compound
added to the contents of the appropriate tubes and poured over the surfaces of selective-agar plates. In activation tests, at least 4 dose levels of the test chemical were added to the appropriate tubes with cells. Just prior to pouring, an aliquot of reaction mixture (0.5 ml containing the 9,000 x g_liver homogenate)
was added to each of the activation overlay tubes, which were then mixed, and the contents poured over the surface of a
minimal agar plate and allowed to solidify. The plates were incubated for 48 hrs at 37°C and scored for the number of colonies growing on each plate“ 04 yeast plates were incubated at 30°C for 3>5 days and then scored. Positive and solvent controls using both directly active positiva chemicals and those that require metabolic activation were run with each assay‘


NUMBER OF REPLICATIONS: 2


DETERMINATION OF CYTOTOXICITY
- Method: Relative total growth
Rationale for test conditions:
Not specified
Evaluation criteria:
EVALUATION CRITERIA

- Evaluation Criteria for Ames Assay: Because the procedures used to evaluate the mutagenicity of the test chemical are semiquantitative, the criteria used to determine positive effects are inherently subjective and are based primarily on a historical data base."Most data sets are evaluated using the
following criteria: .
- l. Strains TA-l535, TA-1537 and TA-1538: If the solvent control value is within the normal range, a chemical that.produces a positive dose response over three concentrations with the lowest increase equal to twice the solvent control value is considered to be mutagenic.
- Strains TA-98, TA-lOO and D4: If the solvent control value is within the-normal range, a chemical that produces a positive dose response over three concen rations with the highest increase equal to twice the solvant control value for TA-lOO and.2-3 times the solvent control value for strains TA-98 and D4 is considered to be mutagenic. For these strains, the dose-response increase should start at approximately the solvent control value.
Statistics:
Not specified

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium, other: TA1535, TA1537, TA1538, TA100 and TA98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
Saccharomyces cerevisiae
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
In this study, the test compound, Biliscopin minor, did not demonstrate genetic activity in any of the assays conducted in this evaluation and was considered not mutagenic under these test conditions.
Executive summary:

In a reverse bacterial mutation assay, the test item was examined for mutagenic potential employing Salmonella typhimurial strains TA1535, TA1537, TA1538, TA98 and TA100 and Saccharomyces cereviciae strain D4 at test concentrations of 1, 10, 50, 100 and 500 µL/plate.

The test compound exhibited slight toxicity with the strains TA1535 and TA100 at the 500 µL dose level. The results.of the tests conducted on the compound in the absence of a metabolic activation system were all negative. The results of the tests conducted on the compound in the presence of a rat liver activation system were all negative. Hence, in this study, it was demonstrated that the test substance is non mutagenic.