Registration Dossier
Registration Dossier
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EC number: 253-168-4 | CAS number: 36727-29-4
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Remarks:
- BASF AG
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3,5,5-trimethylhexanoyl chloride
- EC Number:
- 253-168-4
- EC Name:
- 3,5,5-trimethylhexanoyl chloride
- Cas Number:
- 36727-29-4
- Molecular formula:
- C9H17ClO
- IUPAC Name:
- 3,5,5-trimethylhexanoyl chloride
- Details on test material:
- - Name of test material (as cited in study report): Isononansaeurechlorid
- Analytical purity: 98.4 %
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S-9 mix
- Test concentrations with justification for top dose:
- 20 - 5000 µg/plate (SPT), 60 - 1000 µg/plate (PIT)
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: Salmonella typh. TA 15356,TA 100, TA1537,TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect was observed under all test conditions
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect was observed under all test conditions
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Standard plate test:
Dose (µg/plate) |
TA1535 |
TA100 |
TA1537 |
TA98 |
E. coli WP2 uvrA |
|||||
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
DMSO |
18±2 |
20±1 |
133±12 |
133±9 |
11±1 |
12±1 |
27±1 |
41±4 |
27±4 |
38±3 |
20 µg |
16±2 |
14±1 |
85±6 |
97±2 |
8±2 |
9±1 |
22±2 |
28±3 |
29±5 |
34±0 |
100 µg |
15±2 |
14±1 |
83±3 |
90±2 |
8±0 |
8±1 |
18±2 |
31±1 |
28±3 |
27±2 |
500 µg |
12±2 |
14±3 |
59±3 |
78±10 |
4±2 |
10±1 |
17±1 |
23±1 |
22±1 |
27±1 |
2500 µg |
1B±2 |
1B±0 |
1B±1 |
2B±2 |
1B±1 |
1B±0 |
1B±1 |
2B±1 |
10B±3 |
11B±1 |
5000 µg |
0B |
0B |
0B |
0B |
0B |
0B |
0B |
0B |
0B |
0B |
|
|
|
|
|
|
|
|
|
|
|
MNNG |
848±44 |
|
1005±8 |
|
|
|
|
|
|
|
2-AA |
|
156±1 |
|
1192±131 |
|
187±4 |
|
1823±73 |
|
199±20 |
AAC |
|
|
|
|
1204±7 |
|
|
|
|
|
NOPO |
|
|
|
|
|
|
698±17 |
|
|
|
ENNG |
|
|
|
|
|
|
|
|
940±50 |
|
B: reduced background growth
Preincubation test:
Dose (µg/plate) |
TA1535 |
TA100 |
TA1537 |
TA98 |
E. coli WP2 uvrA |
|||||
|
-S9 |
+S9 |
|
|
|
|
|
|
|
|
DMSO |
19±1 |
20±1 |
114±5 |
121±2 |
10±2 |
10±2 |
20±1 |
37±2 |
30±5 |
39±2 |
60 µg |
16±1 |
18±1 |
114±7 |
123±5 |
7±1 |
7±1 |
19±1 |
36±4 |
27±3 |
32±4 |
125 µg |
16±1 |
14±1 |
95±4 |
121±6 |
6±1 |
8±1 |
16±2 |
30±1 |
23±6 |
33±7 |
250 µg |
5B±1 |
6B±1 |
10B±1 |
44B±14 |
4B±1 |
4B±3 |
11B±1 |
28B±3 |
20±4 |
24±2 |
500 µg |
1B±1 |
2B±1 |
2B±2 |
14B±5 |
1B±0 |
2B±1 |
2B±1 |
10B±1 |
9B±2 |
11B±4 |
1000 µg |
0B |
0B |
0B |
0B |
0B |
0B |
0B |
0B |
0B |
0B |
|
|
|
|
|
|
|
|
|
|
|
MNNG |
861±59 |
|
1060±34 |
|
|
|
|
|
|
|
2-AA |
|
150±17 |
|
993±13 |
|
127±9 |
|
1012±22 |
|
178±26 |
AAC |
|
|
|
|
597±22 |
|
|
|
|
|
NOPO |
|
|
|
|
|
|
889±146 |
|
|
|
ENNG |
|
|
|
|
|
|
|
|
720±8 |
|
Mean ± SD
2-AA: 2-aminoanthracene;
MNNG; N-methyl-N-nitro-N-nitrosoguanidine
ENNG; N-ethyl-N-nitro-N-nitrosoguanidine
NOPO: 4-nitro-o-phenylendiamine
AAC: 9-aminoacridine chloride monohydrate
Applicant's summary and conclusion
- Conclusions:
- According to the results of the present study, the test substance is not mutagenic in the Salmonella typhimurium/Escherichia cali reverse mutation assay under the experimental conditians chosen here.
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