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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Remarks:
(BASF AG, Department of Toxicology)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium β-alaninate
EC Number:
240-734-0
EC Name:
Sodium β-alaninate
Cas Number:
16690-93-0
Molecular formula:
C3H7NO2.Na
IUPAC Name:
sodium 3-aminopropanoate
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Natrium-ß-alaninat, roh ber. 100%
- Physical state: colorless liquid
- Analytical purity: not reported
- Lot/batch No.: not reported
- Date of manufacturing: 11 April 1996
- Stability under test conditions: verified
- Storage condition of test material: room temperature (protected from light)

Method

Target gene:
Histidine and tryptophan auxotrophy
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced rat liver S-9 mix
Test concentrations with justification for top dose:
1st Experiment (standard plate test): 0; 60; 300; 1500; 7500; 15000 µg/plate
2nd Experiment (preincubation test): 0; 12; 60; 300; 1500; 7500 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: water for test substance and DMSO for positive controls
Controlsopen allclose all
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
with S-9 mix
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
N-ethyl-N-nitro-N-nitrosoguanidine
Remarks:
without S-9 mix Migrated to IUCLID6: for WP2 uvrA
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: N-methyl-N-nitro-N-nitrosoguanidine for TA1535
Remarks:
without S-9 mix
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 4-nitro-o-phenylendiamine for TA98
Remarks:
without S-9 mix
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
without S-9 mix Migrated to IUCLID6: for TA1537
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation); preincubation


DURATION
- Preincubation period: 20 min at 37°C
- Exposure duration: 48-72 hr at 37°C


NUMBER OF REPLICATIONS: 3
Evaluation criteria:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results
Statistics:
Mean and standard deviation calculated in result tables. No further data.

Results and discussion

Test resultsopen allclose all
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:
cytotoxicity
Remarks:
at dose level 7500 µg/plate and above
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:
at dose level 7500 µg/plate and above
Vehicle controls validity:
valid
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no


Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Mean Reverants/ plate in Standard plate test

Dose (µg/ml)

             TA 98

          TA 100

         TA 1535

        TA 1537

        WP2uvrA

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

0

33

36

108

12

16

17

9

9

40

51

60

33

42

135

133

14

17

8

9

40

43

300

23

37

135

143

15

14

9

11

46

44

1500

29

36

128

124

15

15

7

7

40

43

7500

26

29

126

137

15

15

9

10

35

37

15000

22

20

110

133

9

13

7

8

23

26

Positive control

1105

1050

1121

1263

1207

136

516

114

762

188

Mean Reverants/ plate in Pre incubation test

Dose (µg/ml)

             TA 98

          TA 100

         TA 1535

        TA 1537

        WP2uvrA

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

0

31

50

132

149

18

18

9

11

40

51

312.5

27

39

133

128

19

19

8

11

32

49

625

33

45

135

161

22

18

9

14

40

44

1250

27

33

139

164

23

17

8

17

36

44

2500

31

43

141

157

23

16

8

9

39

45

5000

11

20

76

122

12

12

4

8

15

20

Positive control

1153

502

1059

1570

1670

148

482

106

758

276

Applicant's summary and conclusion

Executive summary:

This study was conducted in accordance with many guidelines for bacterial mutagenicity testing and is reliable with restrictions as analytical purity of the test substance is not reported. The test substance was tested in 4 Salmonella and 1 E.coli strains at dose levels of 12 -15000 µg/plate. No increase in the number of revertants was detected in any strain with and without metabolic activation. Cytotoxic effect was observed at dose level of 7500 µg/plate and above. Vehicle controls and positive controls were valid.

Conclusion: According to the results of the present study, the test substance Natrium-ß-alaninat, roh ber. 100% is not mutagenic in the Ames test under the experimental conditions chosen here.