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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Bacterial Reverse Mutation Assay

Titanium trichloride (TiCl3 )

In a reverse gene mutation assay in bacteria, performed according to Guidelines for Screening Mutagenicity Testing of Chemicals (Japan), titanium trichloride diluted with dimethylsulfoxide (DMSO) at concentration of 10, 20, 50, 100, 200, 1000 and 2000 μg/plate was tested in S. Typhimurium TA 1538, TA 1535, TA 98 and TA 100 and in E. coli WP2 uvrA in the presence and absence of mamalian metabolic activator (S9) using the preincubation method.

The positive control induced the appropriate response in the corresponding strain.

Titanium trichloride showed potential gene toxicity toward S. typhimirium TA 100 with metabolic activator.

Aluminum chloride

In a reverse gene mutation assay in bacteria, performed according to Guidelines for Screening Mutagenicity Testing of Chemicals (Japan), aluminum chloride diluted with dimethylsulfoxide (DMSO) at concentration of 10, 20, 50, 100, 200, 1000 and 2000μg/plate was tested in S. Typhimurium TA 1538, TA 1535, TA 98 and TA 100 and in E. coli WP2 uvrA in the presence and absence of mamaliaan metabolic activator (S9) using the preincubation method.

The positive control induced the appropriate response in the corresponding strain.

Aluminum chloride showed weak potential gene toxicity toward S. typhimirium TA 100 and TA 98 with and without metabolic activator.

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
This assay was carried out under Japanese Government to survay the potential genotoxicity.
Qualifier:
according to guideline
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Version / remarks:
1979 (Showa 54)
Principles of method if other than guideline:
Pre-incubation method
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Specific details on test material used for the study:
Lot No.: STM2422
Supplier: Wako Pure Chemical Industry
PUrity; Extra pure reagent (not specified)
Stability
Stable under dry and inert atmosphere.
Target gene:
Five strains of S. typhimurium and one strain of E. coli
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
20, 50, 100, 200, 500, 1000, 2000, 5000 μg/plate
Justification for top dose; 5000 μg/plate is the recommended maximum test concentrations.
Vehicle / solvent:
DMSO (Dimethylsulfoxide)
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
furylfuramide
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium; preincubation; in suspension;suspension
- Cell density at seeding (if applicable):not available

DURATION
- Preincubation period:48 h
Evaluation criteria:
A concentration-related increase over the range tested and/or a reproducible increase at one or more concentrations in the number of revertant colonies per plate in at least one strain with or without metabolic activation systems.
Statistics:
Not used
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
5000 μg/plate
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
5000 μg/plate
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
5000 μg/plate
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
5000 μg/plate
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
5000 μg/plate
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
5000 μg/plate
Vehicle controls validity:
valid
Positive controls validity:
valid

Table 1. Test results without S9

Concentration
 
μg/plate

Number ofRevertants/plate

Base-susbstitution

Frame-shift

TA-100

TA1535

WP2uvrA

TA98

TA1537

TA1538

DMSO

103

90

95

88

(94)

15

16

20

25

(19)

48

46

50

52

(49)

9

10

12

12

(11)

9

7

5

5

(7)

12

16

9

10

(12)

20

92

95

(94)

19

14

(17)

55

52

(54)

15

16

(16)

6

6

(6)

10

10

(10)

50

90

98

(94)

25

28

(27)

38

43

(41)

11

12

(12)

4

9

(7)

7

12

(10)

100

88

86

(87)

14

17

(16)

45

44

(45)

13

14

(14)

9

8

(9)

12

8

(10)

200

117

89

(103)

19

11

(15)

34

48

(41)

15

13

(14)

8

4

(6)

9

14

(12)

500

116

107

(112)

17

13

(15)

45

59

(52)

16

13

(15)

5

7

(6)

13

20

(17)

1000

146

130

(138)

16

20

(18)

60

57

(49)

21

25

(23)

10

4

(7)

13

24

(21)

2000

187

210

(199)

13

12

(13)

60

45

(53)

34

37

(36)

10

6

(8)

13

15

(14)

5000

*

*

(*)

*

*

(*)

60

*23

(*42)

*

 

(*)

*

*

(*)

*

*

(*)

Positive control

AF2

0.01μg/plate

361

386

465

398

(403)

NaN3

0.5μg/plate

193

166

183

213

(189)

AF2

0.1μg/plate

457

427

406

402

(423)

AF2

0.1μg/plate

238

220

306

244

(252)

9AA

80μg/plate

767

673

706

801

(737)

2NF

2μg/plate

451

498

466

426

(460)

* ; Cytotoxicity was observed.

AF-2;Furylfuramide NaN3; Sodiumazide, 9AA; 9-Aminoacridine 2-NF; 2-Nitrofluorene

 

Table 2. Test results with S9

Concentration
 
μg/plate

Number ofRevertants/plate

Base-susbstitution

Frame-shift

TA-100

TA1535

WP2uvrA

TA98

TA1537

TA1538

DMSO

122

99

99

112

(108)

17

10

11

15

(13)

42

45

47

43

(44)

22

30

23

19

(24)

8

8

9

4

(7)

22

15

21

27

(21)

20

101

108

(105)

12

9

(11)

35

56

(46)

26

19

(23)

7

15

(11)

29

26

(28)

50

100

107

(104)

18

8

(13)

48

45

(47)

34

30

(32)

9

6

(8)

25

22

(24)

100

114

129

(122)

10

10

(10)

42

54

(48)

35

32

(34)

17

12

(15)

20

23

(22)

200

103

125

(114)

14

17

(16)

44

59

(52)

28

27

(28)

13

11

(12)

29

21

(25)

500

129

125

(127)

8

9

(9)

47

53

(50)

23

30

(27)

10

11

(11)

20

24

(22)

1000

143

182

(163)

9

11

(10)

48

36

(42)

53

45

(49)

9

13

(11)

26

19

(23)

2000

234

223

(229)

17

16

(17)

57

58

(58)

60

64

(62)

6

9

(8)

21

22

(22)

5000

*

*

(*)

*

*

(*)

*28

*15

(*22)

*

*

(*)

*

*

(*)

*11

*

(*6)

Positive control

2AA

0.5μg/plate

583

695

604

669

(638)

2AA

2μg/plate

203

254

258

288

(251)

2AA

10μg/plate

736

632

655

678

(675)

2AA

0.5μg/plate

469

414

495

391

(442)

2AA

2μg/plate

146

171

226

162

(176)

2AA

0.5μg/plate

451

498

466

426

(460)

* : Cytotoxicity was observed.

2AA; 2-Aminoanthracene

Conclusions:
In the reverse mutation assay using 5 strains of S. typhirium and one strain of E. coli with and without metabolic activator (S9), aluminium choride showed weak potential genotoxicity toward TA100 and TA98 with and without metabolic activator.
Executive summary:

In the reverse mutation assay using 5 strains of S. typhirium and one strain of E. coli with and without metabolic activator (S9), aluminium choride showed weak potential genotoxicity toward TA100 and TA98 with and without metabolic activator.

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Version / remarks:
March 8, 1979 (Showa 54)
Principles of method if other than guideline:
Pre-incubation method
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Specific details on test material used for the study:
Lot No. EPP2734
Purity : 98%
Stability; Stable under nitrogen atmosphere
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
10 , 20 , 50 , 100, 200, 500, 1000, 2000 μg/plate
Justification for the top dose was not specified.
Vehicle / solvent:
Dimethylsulfoxide (DMSO)
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
furylfuramide
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium; preincubation; in suspension

DURATION
- Preincubation period:not specified.
- Exposure duration: 48 h

SELECTION AGENT (mutation assays):

NUMBER OF REPLICATIONS: 2
Evaluation criteria:
A concentration-related increase over the range tested and/or a reproducible increase at one or more concentrations in the number of revertant colonies per plate in at least one strain with or without metabolic activation systems.
Statistics:
Not used
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
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
Positive controls validity:
valid

Table 1. Test results without S9

Concentration
 
μg/plate

Number ofRevertants/plate

Base-susbstitution

Frame-shift

TA-100

TA1535

WP2uvrA

TA98

TA1537

TA1538

DMSO

(84)

(14)

(47)

(12)

(7)

(11)

10

89

95

(92)

15

15

(15)

60

45

(53)

9

15

(12)

5

6

(6)

17

9

(13)

20

87

90

(89)

10

13

(12)

44

53

(49)

10

14

(12)

8

5

(7)

18

17

(18)

50

78

73

(76)

13

15

(14)

47

45

(46)

17

16

(17)

4

6

(5)

14

8

(11)

100

89

101

(95)

14

16

(15)

37

45

(41)

15

20

(18)

7

8

(8)

15

18

(17)

200

88

100

(94)

10

12

(11)

57

48

(53)

18

18

(18)

7

5

(6)

9

11

(10)

500

127

127

(127)

12

11

(12)

45

56

(51)

18

19

(19)

7

4

(6)

21

12

(17)

1000

154

130

(142)

10

9

(10)

46

44

(45)

24

20

(22)

4

7

(6)

11

12

(12)

2000

105

96

(101)

7

9

(8)

46

49

(48)

19

17

(18)

5

5

(5)

10

10

(10)

Judgment

Specific Mutagenicity

-

-

 

-

-

-

-

Positive control

AF2

(373)

NaN3

(288)

AF2

(369)

AF2

(310)

9AA

(819)

2NF

(423)

AF-2;Furylfuramide NaN3; Sodiumazide, 9AA; 9-Aminoacridine 2-NF; 2-Nitrofluorene

 

Table 2. Test results with S9

Concentration
 
μg/plate

Number ofRevertants/plate

Base-susbstitution

Frame-shift

TA-100

TA1535

WP2uvrA

TA98

TA1537

TA1538

DMSO

(88)

(12)

(47)

(28)

(10)

(21)

10

81

85

(83)

9

15

(12)

39

61

(50)

24

23

(24)

11

12

(12)

23

13

(18)

20

93

89

(91)

10

17

(14)

39

35

(37)

22

322

(27)

10

11

(11)

17

17

(17)

50

88

86

(87)

15

12

(14)

60

42

(51)

24

34

(29)

18

11

(15)

19

23

(21)

100

109

98

(104)

11

8

(10)

44

60

(52)

38

30

(34)

9

8

(9)

19

18

(19)

200

144

146

(145)

14

13

(14)

62

63

(63)

38

49

(44)

15

4

(10)

30

18

(24)

500

256

256

(256)

12

15

(14)

65

63

(64)

55

47

(51)

6

6

(6)

14

24

(19)

1000

322

326

(324)

18

9

(14)

51

67

(59)

48

40

(44)

4

13

(9)

25

15

(20)

2000

214

222

(218)

7

9

(8)

54

43

(49)

10

21

(16)

6

4

(5)

8

9

(9)

Judgment

Specific Mutagenicity

+

336

-

 

-

-

-

-

Positive control

2AA 0.5

(294)

2AA

(339)

2AA

(666)

2AA

(310)

2AA

(179)

2AA

(279)

2AA; 2-Aminoanthracene

Conclusions:
In the reverse mutation assay using 5 strains of S. typhirium and one strain of E. coli with and without metabolic activator (S9), titanium trichoride showed potential genotoxicity toward TA100 with metabolic activator.
Executive summary:

In the reverse mutation assay using 5 strains of S. typhirium and one strain of E. coli with and without metabolic activator (S9), titanium trichoride showed potential genotoxicity toward TA100 with metabolic activator.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (positive)

Additional information

Justification for classification or non-classification