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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:
September 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
: only average values, no individual plate data given. No reporting details on cytotoxicity given, highest dose only 2500 µg/plate instead of 5000 µg/plate. Unclear whether negative controls were vehicle or water controls.
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Cetyl/Stearylphthalat
- Physical state: not reported
- Analytical purity: no data

Method

Target gene:
His operon
Species / strain
Species / strain / cell type:
other: S. typhimurium TA 1535, TA 1537, TA, 1538, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat liver S9-Mix
Test concentrations with justification for top dose:
0, 4, 20, 100, 500 and 2500 µg/plate
Vehicle / solvent:
Aqueous suspensions of the test substance were freshly made up with Tween 80 before use.
Controls
Untreated negative controls:
yes
Remarks:
deionized water
Negative solvent / vehicle controls:
yes
Remarks:
Tween 80
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: -S9 mix: sodium azide (TA 1535 and 100), 4-Nitro-o-phenylendiamin (TA 1537, 1538 and 98); +S9: 2-Aminoanthracene for all strains.
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation);

DURATION
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: 4

DETERMINATION OF CYTOTOXICITY
- Method: background lawn

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA, 1538, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
No influence on bacterial background lawn or bacterial growth reduction reported.
Vehicle controls validity:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
COMPARISON WITH HISTORICAL CONTROL DATA:
The number of spontaneous mutations was within the range of historical data.

Any other information on results incl. tables

Table 1: Ames Test Results with Cetyl/Stearylphthalat

With or without S9-Mix

Test substance concentration

(μg/plate)

Mean number of revertant colonies per plate

(average of 4 parallel testings)

Base-pair substitution type

Frameshift type

TA 1535

TA 1538

TA 100

TA98

TA1537

-

Negative control

7.2

11.3

92.3

28.3

5.2

-

4

4.0

17.3

89.8

17.5

7.5

-

20

4.8

14.8

115.5

24.8

5.8

-

100

9.5

10.8

133.8

29.0

7.0

-

500

9.3

19.5

97.2

22.5

4.8

-

2500

3.8

14.3

106.0

21.3

7.0

Positive

controls

- S9

Name

SA

4NP

SA

4NP

4NP

Concentrations

(μg/plate)

1

40

1

40

40

Number of colonies/plate

128.3

781.3

653.7

650.0

53.3

 

TA 1535

TA 1538

TA 100

TA98

TA1537

+

Negative control

11.2

25.7

152.5

32.3

8.0

+

4

8.3

24.0

158.8

47.0

4.8

+

20

9.8

21.8

137.8

39.0

8.5

+

100

10.3

23.8

150.0

36.5

6.5

+

500

11.0

24.5

154.5

33.8

9.0

+

2500

12.0

20.3

155.5

36.8

8.3

Positive

controls

+ S9

Name

2AA

2AA

2AA

2AA

2AA

Concentrations

(μg/plate)

5

5

5

5

5

Number of colonies/plate

141.3

1814.0

950.3

2742.7

160.3

SA = Sodium azide

4NP = 4-Nitro-o-phenylendiamin

2AA = 2-Aminoanthracen

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative