Registration Dossier
Registration Dossier
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EC number: 290-580-3 | CAS number: 90193-76-3
Genetic toxicity: in vitro
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:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- 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 substance name:
- 1,2-Benzenedicarboxylic acid, mixed cetyl and stearyl esters
- EC Number:
- 270-487-4
- EC Name:
- 1,2-Benzenedicarboxylic acid, mixed cetyl and stearyl esters
- Cas Number:
- 68442-70-6
- Details on test material:
- - Name of test material (as cited in study report): Cetyl/Stearylphthalat
- Physical state: not reported
- Analytical purity: no data
Constituent 1
Method
- Target gene:
- His operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, 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 resultsopen allclose all
- Species / strain:
- S. typhimurium, other: TA, 1538
- 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
- Species / strain:
- S. typhimurium TA 1535
- 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
- Species / strain:
- S. typhimurium TA 1537
- 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
- Species / strain:
- S. typhimurium TA 98
- 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
- Species / strain:
- S. typhimurium 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
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