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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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1989-04-12 to 1989-04-21
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted according to an appropriate OECD test guideline, with acceptable restrictions. The restrictions were that the range of strains does not comply with the current guideline. Read across to the registered substance is considered scientifically justified.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
range of strains
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: strains TA98, TA100, TA1535, TA1537, and TA1538
Metabolic activation:
with and without
Metabolic activation system:
Aroclor induced rat liver S9
Test concentrations with justification for top dose:
8, 40, 200, 1,000, 5,000 µg/plate
Controlsopen allclose all
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
all strains with metabolic activation
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
TA 1537 without metabolic activation
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
TA 1535 and TA 100 without metabolic activation
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 4-nitro-o-phenylene diamine
Remarks:
TA 98 and TA 1538 without metabolic activation
Details on test system and experimental conditions:
- Number of replicates: Two independent tests each conducted in  triplicate.
- Application: Plate incorporation assay, vehicle aqueous suspension with  Tween 80.
- Incubation time: 48 hours at 37C.
Evaluation criteria:
A two fold increase in reverse mutation  rate is considered positive in strain TA 100 and a 3 fold increase  positive for the other strains.

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA98, TA100, TA1535, TA1537, and TA1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: 5000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
PRECIPITATION CONCENTRATION: Not reported CYTOTOXIC CONCENTRATION:  - With and without metabolic activation: 5000 µg/plate evidenced by  reduced background lawn and/or reduced revertant rates.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1 Experiment 1 revertants per plate (mean of 3 plates)

Concentration µg/plate

TA 1535

TA 100

TA 1537

TA 1538

TA 98

TA 1535

TA 100

TA 1537

TA 1538

TA 98

without metabolic activation

with metabolic activation

0*

8.1

123.4

8.3

13

19.6

11.8

158

12.1

20.1

23.1

8

6.6

110.6

9.3

8.3

17

13.6

151.3

10.3

22.6

22

40

9

99.3

6

8.3

15.3

12.3

128.6

11.3

19

22

200

6

102.6

5.3

10

26.3

8.6

120.3

10.6

17

33.6

1000

7

93.6

7.6

14

20

11.3

102.3

7.3

18.3

33

5000

8

91.3

4.3

10.3

15

12

99.6

4.6

17.6

26.3

Positive control 1

357.3

503

170

1923.6

841.3

112

298

155.6

1347.3

675.6

Positive control 2**

7.6

133.6

6.6

16

19.6

104

1313.6

97.3

1085.3

714.6

* Vehicle control with Tween 80/water

** Positive control 2 is 2-aminoanthracene

 

Table 2 Experiment 2 revertants per plate (mean of 3 plates)

Concentration µg/plate

TA 1535

TA 100

TA 1537

TA 1538

TA 98

TA 1535

TA 100

TA 1537

TA 1538

TA 98

 

without metabolic activation

with metabolic activation

0*

7.5

109.6

7.3

11.5

16.8

11.3

104.6

8.3

14.3

25

8

9

104

12.3

10.3

23.3

8.6

98

12.3

14.3

-

40

9.3

114.3

7.6

9

24.3

9.3

96.6

9.6

14.6

23.5

200

8.3

107.3

10

13.3

24.6

11

103.3

5

15.3

33

1000

7.6

97.6

7.6

11.3

15.6

8.3

118.3

5.3

16.3

25.6

5000

5

90.6

8.3

10.3

21.3

12.6

96.3

6.3

12.6

27.3

Positive control 1

309

325

306.6

1263.3

907.6

146.6

226

206.6

1142.6

597.3

Positive control 2**

9

98.6

4.3

13

22.3

45.6

483.3

27.6

5334.3

339

 

* Vehicle control with Tween 80/water

** Positive control 2 is 2-aminoanthracene

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with and without activation

HD-Ocenol 90/95 has been tested according to OECD 471 and under GLP. The test substance did not increase the reverse mutation rate in histidine dependent bacterial strains of Salmonella typhimurium in the presence or absence of metabolic activation at dose levels up to and including 5000 PRECIPITATION CONCENTRATION: Not reported CYTOTOXIC CONCENTRATION:  - With and without metabolic activation: 5000 µg/plate evidenced by  reduced background lawn and/or reduced revertant rates.
g/plate. Evidence of cytotoxicity was observed at 5000 ug/plate (highest dose level tested). It is concluded that the test substance is negative for mutagenicity to bacteria under the conditons of the test.