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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
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
May 12th, 1987 - June 22nd, 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
: only 3 Salmonella strains tested,
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Glycerides, C12-18
EC Number:
266-944-2
EC Name:
Glycerides, C12-18
Cas Number:
67701-26-2
IUPAC Name:
67701-26-2
Details on test material:
- Name of test material (as cited in study report): C10-18 triglycerides
- Name of test material: Hydrogenated Coco-Glycerides
- Storage condition of test material: desiccated at room temperature in the dark
- Analytical purity: not stated for the tested compound
- Physical state: white pellets

Method

Target gene:
His-Operon
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA97, TA98 and TA100
Metabolic activation:
with and without
Metabolic activation system:
Aroclor-1254 induced rat liver S9 mix
Test concentrations with justification for top dose:
0, 1.6, 8, 40, 200, 1000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: Ethylene glycol dimethyl ether (EGDME)
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
EGDME
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
Migrated to IUCLID6: 2-nitrofluorene (TA98, 50 µg/plate); sodium azide (TA100, 2 µg/plate); 9-aminoacridine (TA97, 50 µg/plate); 2-aminoanthracene (all strains, 5 µg/plate)
Details on test system and experimental conditions:
METHOD OF APPLICATION:
in medium; in agar (plate incorporation);

DURATION
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: 1 experiment with triplicate plating

DETERMINATION OF CYTOTOXICITY
- Method: thinning of background layer and/or presence of microcolonies
Evaluation criteria:
At least 2-fold increase of revertant numbers compared to controls and dose-response correlation.
Statistics:
Analysis of variance and regression analysis.

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA97, TA98 and TA100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity, but tested up to precipitating concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: limited solubility at 1000 µg/plate, but at this dose the precipitated test agent did not interfere with the counting of colonies. Thus 1000 µg/plate was chosen as the highest concentration fur mutation testing.
- Precipitation: yes, at 1000 µg/plate

RANGE-FINDING/SCREENING STUDIES:
Stain TA100 was used for testing up to 5000 µg/plate.

COMPARISON WITH HISTORICAL CONTROL DATA: yes

ADDITIONAL INFORMATION ON CYTOTOXICITY:
No toxicity was observed in TA100 in the absence or presence of S9 mix. At 5000 µg/plate precipitation occured.

Any other information on results incl. tables

Table 1: Ames Test Results after treatment with C10-18 triglycerides

With or without S9-Mix

Test substance concentration

(μg/plate)

Mean number of revertant colonies

per plate

(average of 3 plates)

TA97

TA98

TA100

-

0 (vehicle)

96.0

31.6

120.0

-

1.6

80.7

21.7

131.3

-

8

103.3

23.7

117.5

-

40

88.3

17.0

141.0

-

200

94.0

23.3

144.3

-

1000

92.7ST

16.0P

124.0P

Positive

controls

- S9

Name

9AA

2NF

SA

Concentrations

(μg/plate)

50

50

2

Number of colonies/plate

446.4

920.4

886.8

+

0 (vehicle)

132.2

46.8

138.8

+

1.6

145.0

34.3

152.7

+

8

152.0

36.7

140.3

+

40

165.7

37.0

141.3

+

200

142.3

44.7

143.7

+

1000

142.0P

52.3P

139.7P

Positive

controls

+ S9

Name

2AA

2AA

2AA

Concentrations

(μg/plate)

5

5

5

Number of colonies/plate

499.8

689.2

888.4

2AA = 2-aminoanthracene

2NF = 2-nitrofluorene

SA = sodium azide

9AA = 9-aminoacridine

P= Precipitation observed

ST= signs of toxicity observed (thinning of background layer and/or presence of microcolonies)

 

 

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative in TA97, TA98 and TA100