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EC number: 202-625-6 | CAS number: 97-99-4
- Life Cycle description
- Uses advised against
- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not reported
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- The Japanese relevant authority has stated clearly in secondary summaries that this study was conducted in compliance with GLP. However, some pages, which may contain the confirmation of GLP compliance, are missing from the published study report. Overall, the studies are the part of safety evaluation by the national authority of Japan (from Japan Existing Chemical Data Base (JECDB)). The data are collected under the control of the authority and approved by the GLP authority, which are under national control. Therefore we consider that the studies are in compliance with GLP although GLP or QA statement is not included in the available study reports.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- 2AA- only control with metabolic activation
- GLP compliance:
- yes
- Remarks:
- evidence of GLP is not included in the report
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tetrahydrofurfuryl alcohol
- EC Number:
- 202-625-6
- EC Name:
- Tetrahydrofurfuryl alcohol
- Cas Number:
- 97-99-4
- Molecular formula:
- C5H10O2
- IUPAC Name:
- tetrahydrofuran-2-ylmethanol
- Details on test material:
- Name of test substance; Tetrahydrofurfuryl alcohol
Structural formula; see attachment
Molecular weight; 102.13
Purity; 99.5%
Impurity; 5-Methyltetrahydrofurfuryl alcohol (GC): 0.34%
Appearance under ambient temperature; transparent liquid
Substance type; Pure active substance
Lot. No.; not reported
Constituent 1
Method
- Target gene:
- S. typhimurium TA100 and TA1535; his G (base-pair substitution)
S. typhimurium TA98; his D (frameshift)
S. typhimurium TA 1537; his C (frameshift)
E. coli WP2uvrA/pK101; trp E (base-pair substitute)
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital and tetrahydrofurfuryl alcohol induced rat liver S9
- Test concentrations with justification for top dose:
- Tester strains; TA 100, TA1535, WP2uvrA/pK101, TA 98 and TA 1537: 5000, 2500, 1250, 625 and 313 µg/plate (with or without S9 mix)
Positive substance;
with S9 mix: TA 100 (2-aminoanthracene (2-AA); 1 µg/plate), TA1535 (2-AA; 2 µg/plate), WP2uvrA/pK101 (2-AA; 2 µg/plate), TA 98 (2-AA; 0.5 µg/plate) and TA 1537 (2-AA; 2 µg/plate)
without S9 mix: TA 100 (furfurylamide (AF-2); 0.01 µg/plate), TA1535 (sodium azide (NaN3); 0.5 µg/plate), WP2uvrA/pK101 (ENNG; 2 µg/plate), TA 98 (AF-2; 0.5 µg/plate) and TA 1537 (9-AA; 2 µg/plate) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Water for injection (Otsuka Pharmaceutical Factory, Inc., Lot No.; K0C78)
- Justification for choice of solvent/vehicle: The test substance was soluble in water for injection (DW) at the concentration of 50 mg/ml in the preliminary test for selection of solvent. No exothermic, bubbling and discoloration was observed when DW was added. Based on these results, DW was used for solvent.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- furylfuramide
- Remarks:
- AF-2 (Lot No.; CAP0185, content; 98.9%, Wako Pure Chemical Industries, Ltd.), Solvent: DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- NaN3 (Lot No.; KWE6685, content; 96.5%, Wako Pure Chemical Industries, Ltd.), Solvent: DW
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- ENNG (Lot No. 56F-3651, content; 99.0%, Sigma Chemical Company), Solvent: DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DW
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- 9-AA (Lot No., 80F-0186, content; >99%, Sigma Chemical Company), Solvent: DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterile distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-AA)
- Remarks:
- 2-AA (Lot No. TWH2355, content; 98.0%, Wako Pure Chemical Industries, Ltd.), Solvent: DMSO
- Details on test system and experimental conditions:
- 1. Tester strain;
Five tester strains, Salmonella typhimurium strains TA100, TA1535, TA98 and TA1537 which were obtained from the University of California on May 27, 1983 and Escherichia coli strain WP2uvrA/pKM101 which was obtained from Japan Bioassay Research Center were used. These strains are widely used for bacterial reverse mutation test, and are recommended by OECD Guidelines and the guideline in Japanese Chemical Substances Control Law.
2. Bacterial suspension;
Each frozen tester strains were thawed at use, and aliquot of 20 µl was taken and inoculated to 10 µl of liquid complete medium. They were incubation under shaking culture for 8 hours at 37°C (90 agitation/min.). L-shaped tube (capacity; 22 ml) was used for culturing vessel. After incubation period was finished, turbidity of bacterial suspension was measured with turbidity meter. Viable bacteria count was calculated by conversion from turbidity. The appropriate bacterial concentration (10 E+09/ml or more) was confirmed in the suspension and then used for the test (Note 2).
3. Reverse mutation test;
The test was conducted by pre-incubation method with and without S9 mix. For each dosage, 0.1 ml of test substance solution or negative (solvent) control material was added into sterilized tube, and then 0.5 ml of 0.1 mol/l sodium-phosphate buffer (pH 7.4) (without S9 mix) or 0.5 ml of S9 mix (with S9 mix) was added. Then 0.1 ml of bacterial suspension was added and was shaking-incubated at 37°C for 20 minutes. After pre-incubation, 2 ml of top agar was added to the mixture and was multilayered onto minimum glucose agar plate medium. After solidification of multilayered top agar, it was incubated at 37°C for 48 hours. Growth of bacterial flora was observed with stereoscopic microscope to investigate degree of bacterial growth inhibition by test material and then the presence of precipitation was investigated by visual inspection. Number of revertant colonies on the plate was counted with automatic colony counter (CA-11, System Science Co., Ltd.; correction method: area and miscount correction). Tests for the positive control materials were conducted similarly. - Evaluation criteria:
- If more than 2-fold increase is noted in the number of revertant colonies (mean value) compared with negative (solvent) control with our without S9 mix in any tester strain and also if reproducibility is noted in such increase, test substance is judged to have mutagenicity (positive). For other case, it is judged as negative.
- Statistics:
- No statistical method was used for judgment of test results.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- 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
- Additional information on results:
- The numbers of revertant colonies were below 2 fold of negative (solvent) control value at the dosages of 5000, 1250, 313, 78.1, 19.5, 4.88 and 1.22 µg/plate for all tester strains with or without S9 mix as the result of the preliminary test. No growth inhibition and no precipitation were observed for any tester strain with or without S9 mix.
Based on above results, main tests were conducted at 5 dosages of 5000, 2500, 1250, 625 and 313 µg/plate for all tester strains.
As the result of 2 main tests, the numbers of revertant colonies for all tester strains were below 2 folds of negative (solvent) control value with or without S9 mix. No growth inhibition and no precipitation were observed for any tester strain with or without S9 mix.
From sterility tests for the test substance solution at the highest concentration and S9 mix, no contamination by bacteria or mould which affected the results of the tests was observed.
Based on the results of preliminary test, main tests were conducted with the highest concentration of 5000 µg/plate.
Number of revertant colonies was below 2 folds of negative (solvent) control value for all tester strains with
or without S9 mix.
It was confirmed that the test was appropriately conducted because negative (solvent) control value and positive
control value in this test are within the normal range which calculated from historical background data, and because
positive control material showed positive result with significant increase of over 2 fold in the number of revertant
colonies which was induced by the positive control material in each tester strains with or without S9 mix compared
with the number of negative (solvent) control in each tester strains.
Based on above results, it was concluded that tetrahydrofurfuryl alcohol has no mutagenicity (negative) for
bacterial reverse mutation test.
Any other information on results incl. tables
Pre-experiment for toxicity
Whether or not there is metabolic activation |
Dosage level of the test substance (µg/plate) |
Number of reverse mutations (number of colonies/plate) |
|||||
Base pair substitution type |
Frame shift type |
||||||
TA100 |
TA1535 |
WP2uvrA/pKM101 |
TA98 |
TA1537 |
|||
-S9 mix |
Negative control |
114 |
9 |
81 |
16 |
17 |
|
1.22 |
130 |
10 |
87 |
23 |
23 |
||
4.88 |
109 |
8 |
84 |
24 |
24 |
||
19.5 |
123 |
13 |
67 |
26 |
29 |
||
78.1 |
116 |
14 |
71 |
24 |
24 |
||
313 |
126 |
10 |
83 |
18 |
22 |
||
1250 |
118 |
8 |
65 |
27 |
24 |
||
5000 |
105 |
13 |
73 |
26 |
25 |
||
+S9 mix |
Negative control |
113 |
8 |
78 |
32 |
24 |
|
1.22 |
117 |
10 |
86 |
26 |
31 |
||
4.88 |
126 |
14 |
114 |
35 |
20 |
||
19.5 |
120 |
11 |
112 |
25 |
24 |
||
78.1 |
128 |
8 |
89 |
34 |
30 |
||
313 |
123 |
9 |
125 |
39 |
22 |
||
1250 |
114 |
8 |
104 |
32 |
27 |
||
5000 |
108 |
11 |
88 |
33 |
25 |
||
Positive control |
Positive control groups for which S9 mix is not necessary |
Name |
AF-2 |
NaN3 |
ENNG |
AF-2 |
9-AA |
Dosage (µg/plate) |
0.01 |
0.5 |
2 |
0.1 |
80 |
||
(Number of colonies/plate) |
551 |
467 |
3659 |
697 |
263 |
||
Positive control groups for whichS9mix is necessary |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
|
Dosage (µg/plate) |
1 |
2 |
2 |
0.5 |
2 |
||
(Number of colonies/plate) |
1298 |
182 |
625 |
400 |
184 |
Results of main experiment 1, preincubation; revertants per plate (mean and s.d.)
Whether or not there is metabolic activation |
Dosage level of test substance (µg/plate) |
Number of reverse mutations (number of colonies/plate) |
||||||||||
Base pair substitution type |
Frame shift type |
|||||||||||
TA100 |
TA1535 |
WP2uvrA/ pKM101 |
TA98 |
TA1537 |
||||||||
-S9 mix |
Negative control |
103 123 113 |
(113) (± 10) |
14 11 11 |
(12) (± 2) |
82 75 87 |
(81) (± 6) |
22 20 22 |
(21) (± 1) |
17 16 17 |
(17) (± 1) |
|
313 |
97 103 122 |
(107) (± 13) |
11 8 10 |
(10) (± 2) |
93 73 92 |
(86) (± 11) |
17 23 21 |
(20) (± 3) |
16 21 15 |
(17) (± 3) |
||
625 |
112 122 108 |
(114) (± 7) |
10 8 12 |
(10) (± 2) |
76 76 98 |
(83) (± 13) |
21 20 19 |
(20) (± 1) |
15 18 14 |
(16) (± 2) |
||
1250 |
110 134 96 |
(113) (± 19) |
14 11 10 |
(12) (± 2) |
63 77 95 |
(78) (± 16) |
31 18 25 |
(25) (± 7) |
18 20 15 |
(18) (± 3) |
||
2500 |
116 109 111 |
(112) (± 4) |
11 9 9 |
(10) (± 1) |
93 81 92 |
(89) (± 7) |
20 17 24 |
(20) (± 4) |
17 11 17 |
(15) (± 3) |
||
5000 |
118 119 102 |
(113) (± 10) |
10 16 11 |
(12) (± 3) |
87 70 91 |
(83) (± 11) |
17 21 17 |
(18) (± 2) |
17 23 15 |
(18) (± 4) |
||
+S9 mix |
Negative control |
128 127 102 |
(119) (± 15) |
13 8 15 |
(12) (± 4) |
99 106 99 |
(101) (± 4) |
33 24 23 |
(27) (± 6) |
25 24 22 |
(24) (± 2) |
|
313 |
114 120 119 |
(118) (± 3) |
9 11 11 |
(10) (± 1) |
87 111 92 |
(97) (± 13) |
40 23 29 |
(31) (± 9) |
26 27 21 |
(25) (± 3) |
||
625 |
137 98 125 |
(120) (± 20 |
13 10 12 |
(12) (± 2) |
92 102 77 |
(90) (± 13) |
33 30 23 |
(29) (± 5) |
27 23 22 |
(24) (± 3) |
||
1250 |
108 126 106 |
(113) (± 11) |
12 11 17 |
(13) (± 3) |
104 111 112 |
(109) (± 4) |
30 31 37 |
(33) (± 4) |
22 27 24 |
(24) (± 3) |
||
2500 |
113 120 123 |
(119) (± 5) |
10 16 15 |
(14) (± 3) |
109 95 112 |
(105) (± 9) |
29 29 33 |
(30) (± 2) |
26 24 18 |
(23) (± 4) |
||
5000 |
101 120 113 |
(111) (± 10) |
10 18 13 |
(14) (± 4) |
86 113 116 |
(105) (± 17) |
23 33 23 |
(26) (± 6) |
25 30 29 |
(28) (± 3) |
||
Positive control |
Positive control groups for which S9 mix is not necessary |
Name |
AF-2 |
NaN3 |
ENNG |
AF-2 |
9-AA |
|||||
Dosage (µg/plate) |
0.01 |
0.5 |
2 |
0.1 |
80 |
|||||||
(Number of colonies/plate) |
564 555 533 |
(551) (± 16)
|
520 476 468 |
(488) (± 28) |
4412 4259 3992 |
(4221) (± 213) |
632 644 625 |
(634) (± 10) |
292 237 346 |
(292) (± 55) |
||
Positive control groups for whichS9mix is necessary |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
||||||
Dosage (µg/plate) |
1 |
2 |
2 |
0.5 |
2 |
|||||||
(Number of colonies/plate) |
1381 1446 1443 |
(1423) (± 37) |
169 149 171 |
(163) (± 12) |
935 955 925 |
(938) (± 15) |
436 437 451 |
(441) (± 8) |
171 167 175 |
(171) (± 4) |
AF-2:2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
NaN3: Sodium azide
ENNG:N-ethyl-N’-nitro-N-nitrosoguanidine,
9-AA:9-Aminoacridine hydrochloride,
2-AA:2-Aminoanthracene
Results of main experiment 2, preincubation; revertants per plate (mean and s.d.)
Whether or not there is metabolic activation |
Dosage level of test substance (µg/plate) |
Number of reverse mutations (number of colonies/plate) |
||||||||||
Base pair substitution type |
Frame shift type |
|||||||||||
TA100 |
TA1535 |
WP2uvrA/ pKM101 |
TA98 |
TA1537 |
||||||||
-S9 mix |
Negative control |
121 118 102 |
(114) (± 10) |
16 15 14 |
(15) (± 1) |
82 85 88 |
(85) (± 3) |
19 22 22 |
(21) (± 2) |
18 14 11 |
(14) (± 4) |
|
313 |
127 111 108 |
(115) (± 10) |
14 11 12 |
(12) (± 2) |
96 94 86 |
(92) (± 5) |
24 24 26 |
(25) (± 1) |
17 16 15 |
(16) (± 1) |
||
625 |
95 106 107 |
(103) (± 7) |
9 10 10 |
(10) (± 1) |
95 86 89 |
(90) (± 5) |
16 24 25 |
(22) (± 5) |
16 16 15 |
(16) (± 1) |
||
1250 |
110 112 117 |
(113) (± 4) |
10 11 12 |
(11) (± 1) |
76 90 88 |
(85) (± 8) |
17 25 21 |
(21) (± 4) |
14 18 17 |
(16) (± 2) |
||
2500 |
101 105 105 |
(104) (± 2) |
13 9 15 |
(12) (± 3) |
86 90 91 |
(89) (± 3) |
16 17 20 |
(18) (± 2) |
15 13 17 |
(15) (± 2) |
||
5000 |
121 98 130 |
(116) (± 17) |
8 11 14 |
(11) (± 3) |
93 87 81 |
(87) (± 6) |
26 18 23 |
(22) (± 4) |
12 10 12 |
(11) (± 1) |
||
+S9 mix |
Negative control |
110 127 108 |
(115) (± 10) |
11 11 16 |
(13) (± 3) |
93 95 87 |
(92) (± 4) |
32 29 35 |
(32) (± 3) |
23 23 15 |
(20) (± 5) |
|
313 |
123 114 126 |
(121) (± 6) |
12 13 13 |
(13) (± 1) |
88 111 91 |
(97) (± 13) |
24 31 27 |
(27) (± 4) |
20 17 22 |
(20) (± 3) |
||
625 |
124 119 110 |
(118) (± 7) |
14 16 14 |
(15) (± 1) |
90 87 103 |
(93) (± 9) |
39 21 24 |
(28) (± 10) |
18 22 29 |
(23) (± 6) |
||
1250 |
121 115 112 |
(116) (± 5) |
10 13 10 |
(11) (± 2) |
87 95 102 |
(95) (± 8) |
25 28 33 |
(29) (± 4) |
22 25 22 |
(23) (± 2) |
||
2500 |
108 99 116 |
(108) (± 9) |
14 10 13 |
(12) (± 2) |
90 96 108 |
(98) (± 9) |
24 27 30 |
(27) (± 3) |
22 16 20 |
(19) (± 3) |
||
5000 |
108 114 102 |
(108) (± 6) |
9 13 10 |
(11) (± 2) |
101 87 108 |
(99) (± 11) |
25 25 28 |
(26) (± 2) |
22 19 19 |
(20) (± 2) |
||
Positive control |
Positive control groups for which S9 mix is not necessary |
Name |
AF-2 |
NaN3 |
ENNG |
AF-2 |
9-AA |
|||||
Dosage (µg/plate) |
0.01 |
0.5 |
2 |
0.1 |
80 |
|||||||
(Number of colonies/plate) |
563 520 482 |
(552) (± 41)
|
369 387 440 |
(399) (± 37) |
4358 4439 4275 |
(4357) (± 82) |
632 618 590 |
(613) (± 21) |
242 209 209 |
(220) (± 19) |
||
Positive control groups for whichS9mix is necessary |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
||||||
Dosage (µg/plate) |
1 |
2 |
2 |
0.5 |
2 |
|||||||
(Number of colonies/plate) |
1398 1398 1301 |
(1366) (± 56) |
150 147 138 |
(145) (± 6) |
1347 1373 1072 |
(1264) (± 167) |
432 428 423 |
(428) (± 5) |
200 182 194 |
(192) (± 9) |
Applicant's summary and conclusion
- Conclusions:
- Tetrahydrofurfuryl alcohol has been tested according to a Japanese national method that is equivalent to OECD TG 471. No evidence of test-substance induced increases in the number of revertants was obtained using S. typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2, with and without metabolic activation, in either the initial or the repeat experiment, both of which used the pre-incubation method. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
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