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EC number: 816-315-9 | CAS number: 70024-75-8
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
- Justification for type of information:
- Please see attached justification for read across in Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- 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:
- weight of evidence
- Study period:
- 01 Mar - 11 Mar 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study with acceptable restrictions (no analytical purty reported; no E.coli strain tested)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in 1983
- Deviations:
- yes
- Remarks:
- no analytical purty reported; no E.coli strain tested
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his operon
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- First and second experiment: 8, 40, 200, 1000 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Tween 80 / water
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: With and Without S9: sodium azide (2 µg/plate) for TA100 and TA1535; 9-aminoacridine (80 µg/plate) for TA1537; 4-nitro-o-phenylendiamine (40 µg/plate) for TA98 and TA1538. With and without S9: 2 aminoanthracene (2-AA; 2.5 or 5 µg/plate) 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: triplicates each in two independent experiments - Rationale for test conditions:
- In accordanec with test guidelines
- Evaluation criteria:
- The test material was considered positive in this test system if the following criteria were met:
- The plate background from the non revertant bacteria showed no growth reduction in comparison to the correspondent negative control.
- The spontaneous mutation rate of the strains tested was within the characteristic range of the spontaneous mutation.
- The positive controls showed mutation rates that exceeded the control values of the TA100 at least by a factor 2.0 and the other tester strains, at least by a factor 3.0.
- For the test item, two-fold increases in mean revertant numbers were observed at more then one dose level in TA 100. For the other strains, an increase in the mutation rate greater than three-fold in comparison to the correspondent negative control was observed. - Statistics:
- Mean values and standard deviation were calculated.
- Key result
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
Table 1: Test Results of Experiment 1 (plate incorporation)
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 |
|||||||||||
– |
0 |
70.3 ± 8.7 |
8.6 ± 1.8 |
15.3 ± 2.2 |
15.8 ± 5.8 |
7.8 ± 1.1 |
|||||||||
– |
8 |
70.3 ± 9.2 |
6.0 ± 1.7 |
6.0 ± 1.0 |
15.3 ± 3.7 |
3.0 ± 1.0 |
|||||||||
– |
40 |
73.6 ± 6.3 |
8.3 ± 2.0 |
5.3 ± 1.5 |
14.6 ± 1.5 |
5.3 ± 2.5 |
|||||||||
– |
200 |
77.0 ± 5.2 |
9.0 ± 1.0 |
6.0 ± 2.6 |
12.6 ± 3.2 |
5.0 ± 1.7 |
|||||||||
– |
1000 |
71.6 ± 2.0 |
8.3 ± 1.1 |
8.6 ± 1.5 |
13.3 ± 1.5 |
7.0 ± 2.6 |
|||||||||
– |
5000 |
78.6 ± 13.0 |
5.0 ± 1.7 |
7.6 ± 2.8 |
11.0 ± 4.0 |
3.3 ± 1.1 |
|||||||||
Positive controls, –S9 |
Name |
NaA |
2AA |
NaA |
2AA |
4NOPD
|
2AA |
4NOPD
|
2AA |
9AA
|
2AA |
||||
Concentrations (μg/plate) |
2.0 |
5.0 |
2.0 |
2.5 |
40.0 |
5.0 |
40.0 |
5.0 |
80 |
2.5 |
|||||
Mean No. of colonies/plate (average of 3) |
235 ± 30.6 |
69.6 ± 1.5 |
255.3 ± 24.8 |
6.3 ± 0.57 |
844.0 ± 54.6 |
9.6 ± 4.7 |
370.0 ± 14.7 |
16.6 ± 3.5 |
146.0 ± 9.6 |
4.6 ± 1.5 |
|||||
+ |
0 |
83.5 ± 11.5 |
10.5 ± 2.5 |
14.5 ± 2.0 |
20.8 ± 3.9 |
7.6 ± 0.51 |
|||||||||
+ |
8 |
76.3 ± 2.0 |
9.6 ± 1.1 |
14.0 ± 3.0 |
17.6 ± 3.5 |
5.3 ± 2.5 |
|||||||||
+ |
40 |
74.6 ± 5.6 |
8.3 ± 1.1 |
13.6 ± 1.5 |
15.3 ± 1.5 |
6.3 ± 2.5 |
|||||||||
+ |
200 |
82.6 ± 0.57 |
10.0 ± 1.0 |
12.6 ± 2.8 |
19.6 ± 0.6 |
5.6 ± 3.0 |
|||||||||
+ |
1000 |
90.3 ± 5.5 |
13.6 ± 4.7 |
11.3 ± 3.2 |
19.6 ± 6.1 |
7.3 ± 3.2 |
|||||||||
+ |
5000 |
80.3 ± 16.1 |
12.6 ± 1.5 |
9.0 ± 1.7 |
22.3 ± 3.7 |
7.6 ± 0.6 |
|||||||||
Positive controls, + S9 |
Name |
NaA |
2AA |
NaA |
2AA |
4NOPD
|
2AA |
4NOPD
|
2AA |
9AA
|
2AA |
||||
Concentrations (μg/plate) |
2.0 |
5.0 |
2.0 |
2.5 |
40.0 |
5.0 |
40.0 |
5.0 |
80 |
2.5 |
|||||
Mean No. of colonies/plate (average of 3) |
125.3 ± 9.6 |
1292.6 ± 100.4 |
44.0 ± 8.8 |
223.6 ± 47.0 |
793.6 ± 50.0 |
441.0 ± 49.3 |
450.0 ± 32.0 |
643.3 ± 137.3 |
61.6 ± 2.8 |
75.6 ± 7.5 |
|||||
Table 2: Test Results of Experiment 2 (plate incorporation)
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 |
|||||||||||
– |
0 |
90.0 ± 6.8 |
9.5 ± 4.7 |
11.1 ± 3.8 |
16.8 ± 1.9 |
5.8 ± 1.1 |
|||||||||
– |
8 |
86.0 ± 6.2 |
9.0 ± 2.0 |
7.6 ± 3.0 |
17.6 ± 0.6 |
5.3 ± 3.2 |
|||||||||
– |
40 |
89.0 ± 14.7 |
11.6 ± 2.0 |
7.0 ± 3.4 |
15.6 ± 4.0 |
6.6 ± 2.0 |
|||||||||
– |
200 |
100.6 ± 14.2 |
5.0 ± 2.0 |
9.6 ± 2.5 |
12.0 ± 2.6 |
4.3 ± 1.1 |
|||||||||
– |
1000 |
90.0 ± 10.8 |
10.0 ± 2.6 |
12.0 ± 5.1 |
14.0 ± 3.4 |
5.6 ± 3.0 |
|||||||||
– |
5000 |
97.0 ± 17.4 |
7.3 ± 2.0 |
8.0 ± 2.0 |
12.6 ± 3.0 |
5.6 ± 2.8 |
|||||||||
Positive controls, –S9 |
Name |
NaA |
2AA |
NaA |
2AA |
4NOPD
|
2AA |
4NOPD
|
2AA |
9AA
|
2AA |
||||
Concentrations (μg/plate) |
2.0 |
5.0 |
2.0 |
2.5 |
40.0 |
5.0 |
40.0 |
5.0 |
80 |
2.5 |
|||||
Mean No. of colonies/plate (average of 3) |
318.0 ± 22.2 |
104.0 ± 6.2 |
340.3 ± 14.5 |
10.3 ± 4.0 |
1009.0 ± 44.3 |
7.0 ± 1.7 |
441.6 ± 19.3 |
20.0 ± 1.7 |
211.6.± 20.5 |
7.3 ± 2.0 |
|||||
+ |
0 |
96.5± 15.8 |
10.3 ± 1.9 |
16.3 ± 3.1 |
17.1 ± 4.0 |
7.8 ± 2.4 |
|||||||||
+ |
8 |
94.3 ± 10.0 |
10.0 ± 2.6 |
17.0 ± 2.0 |
17.3 ± 1.1 |
7.3 ± 1.1 |
|||||||||
+ |
40 |
94.0 ± 4.3 |
10.6 ± 2.5 |
17.0 ± 4.5 |
16.6 ± 1.1 |
5.3 ± 0.6 |
|||||||||
+ |
200 |
105.0 ± 4.5 |
8.6 ± 3.0 |
13.6 ± 1.5 |
16.6 ± 4.0 |
7.0 ± 2.0 |
|||||||||
+ |
1000 |
108.6 ± 7.3 |
12.3 ± 5.0 |
14.3 ± 4.0 |
18.6 ± 2.5 |
6.3 ± 1.5 |
|||||||||
+ |
5000 |
112.0 ± 9.6 |
10.3 ± 1.1 |
9.60 ± 1.5 |
16.3± 7.0 |
4.6 ± 1.5 |
|||||||||
Positive controls, + S9 |
Name |
NaA |
2AA |
NaA |
2AA |
4NOPD
|
2AA |
4NOPD
|
2AA |
9AA
|
2AA |
||||
Concentrations (μg/plate) |
2.0 |
5.0 |
2.0 |
2.5 |
40.0 |
5.0 |
40.0 |
5.0 |
80 |
2.5 |
|||||
Mean No. of colonies/plate (average of 3) |
156.6 ± 14.2 |
884.6 ± 109.5 |
95.3 ± 6.4 |
114.3 ± 45.2 |
1204.6 ± 38.0 |
569.0 ± 62.0 |
635.3 ± 27.7 |
421.3 ± 30.0 |
88.3 ± 33.2 |
54.3 ± 16.0 |
|||||
9AA = 9-aminoacridine
2AA = 2-Aminoanthracene
NaA= Sodiumazide
4NOPD= 4-Nitro-o-phenylendiamin
Data source
Materials and methods
Test material
- Reference substance name:
- Esterification products of 2,2-dimethylpropane-1,3-diol with n-heptanoic acid and n-octanoic acid and n-decanoic acid
- EC Number:
- 816-315-9
- Cas Number:
- 70024-75-8
- Molecular formula:
- C18H34O4 to C25H48O4 (in CH2 increments)
- IUPAC Name:
- Esterification products of 2,2-dimethylpropane-1,3-diol with n-heptanoic acid and n-octanoic acid and n-decanoic acid
- Test material form:
- liquid
Constituent 1
Results and discussion
Test resultsopen allclose all
- Key result
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
