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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:
16 July - 27 July 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (Strain S. typhimurium TA102 or E.coli WP2 were not tested).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Strain S. typhimurium TA102 or E.coli WP2 not tested.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-18, esters with pentaerythritol
EC Number:
285-547-5
EC Name:
Fatty acids, C16-18, esters with pentaerythritol
Cas Number:
85116-93-4
IUPAC Name:
85116-93-4
Details on test material:
- Name of test material (as cited in study report): fatty acid C16-18, ester with pentaerythriol
- Physical state: white, solid, powder
- Analytical purity: 99%
- Lot/batch No.: 51531022
- Stability under test conditions: 18 months
- Storage condition of test material: room temperature

Method

Target gene:
His-operon
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
other: rfa-, uvR-, Strains 98 and 100 also R+
Species / strain / cell type:
S. typhimurium TA 1538
Additional strain / cell type characteristics:
other: rfa-, uvR-
Metabolic activation:
with and without
Metabolic activation system:
cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254
Test concentrations with justification for top dose:
8, 40, 200, 1000 and 5000 µg/plate
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
2 µg/plate; TA100 and TA1535 (-S9)
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
80 µg/plate; TA1537 (-S9)
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 4-nitro-o-phenylendiamine
Remarks:
40 µg/plate; TA98 and TA1538 (- S9)
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-Aminoanthracene
Remarks:
all strains with metabolic activation; 2.5 µg/plate: TA1535, TA1537; 5 µg/plate: TA100, TA1538, TA98

Results and discussion

Test resultsopen allclose all
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:
no cytotoxicity, but tested up to precipitating concentrations
Remarks:
Precipitate was seen at concentrations of 1000 µg/plate and higher
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
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:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1: Mutagenicity of the test item on bacteria - experiment I

 

With or without S9-Mix

Test substance concentration

(μg/plate)

Mean number of revertant colonies per plate

(average of 3 plates)

Base-pair substitution type

Frameshift type

TA 100

TA1535

TA1538

TA98

TA1537

-

Buffer

116

9

10

22

7

 

Vehicle

112

11

12

34

10

-

8

114

10

7

29

10

-

40

111

10

8

34

7

-

200

114

8

9

29

8

-

1000

120

12

7

25

6

-

5000

132

6

9

29

6

Positive

controls

- S9

Name

SA

SA

4NP

4NP

9AA

Concentrations

(μg/plate)

2.0

2.0

40

40

80

Number of colonies/plate

818

621

1792

1571

1025

+

Buffer

116

11

15

38

6

+

Vehicle

103

12

15

35

10

+

8

115

12

16

34

8

+

40

120

9

11

39

8

+

200

113

12

13

38

10

+

1000

126

11

14

39

7

+

5000

130

13

12

3934

7

Positive

controls

+ S9

Name

2AA

2AA

 2AA

 2AA

 2AA

Concentrations

(μg/plate)

5.0

2.5

5.0

5.0

2.5

Number of colonies/plate

1594

210

1769

1572

66

 

4NP= 4-nitro-o-phenylendiamine

SA = sodium azide

9AA = 9 -aminoacridine

2AA = 2 -aminoanthracene

 

 

 

Table 2: Mutagenicity of the test item on bacteria - experiment II

 

With or without S9-Mix

Test substance concentration

(μg/plate)

Mean number of revertant colonies per plate

(average of 3 plates)

Base-pair substitution type

Frameshift type

TA 100

TA1535

TA1538

TA98

TA1537

-

Buffer

122

11

13

34

6

 

Vehicle

127

13

9

39

13

-

8

116

12

11

30

10

-

40

110

14

12

31

8

-

200

121

13

14

39

5

-

1000

111

17

18

29

7

-

5000

122

16

13

32

10

Positive

controls

- S9

Name

SA

SA

4NP

4NP

9AA

Concentrations

(μg/plate)

2.0

2.0

40

40

80

Number of colonies/plate

1018

824

1929

1643

1017

+

Buffer

127

15

19

40

9

+

Vehicle

116

21

20

43

10

+

8

128

11

19

46

10

+

40

126

17

19

49

6

+

200

115

13

19

45

9

+

1000

121

19

16

49

10

+

5000

127

21

14

40

7

Positive

controls

+ S9

Name

2AA

2AA

 2AA

2AA

2AA

Concentrations

(μg/plate)

5.0

2.5

5.0

5.0

2.5

Number of colonies/plate

1535

327

1384

1515

64

 

4NP= 4-nitro-o-phenylendiamine

SA = sodium azide

9AA = 9 -aminoacridine

2AA = 2 -aminoanthracene

 

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative