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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In a reliable GLP OECD Guideline 471 study, Harpin-ab Fermentation Extract was tested in a bacterial reverse mutation assay in Salmonella typhimurium (strains TA 98, TA 100, TA 102, TA 1535 and TA 1537) with and without metabolic activation (S9). The results show that Harpin-ab Fermentation Extract did not cause a positive increase in the mean number of revertants per plate with any of the tester strains either in the presence or absence of S9.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 February - 09 March 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- TEST MATERIAL
- Lot No. of test material: R134-2
- Expiration date of the lot: 17 July 2018
- Appearance: Tan, light brown liquid
- Active components: Harpin-ab proteins 0.4% in aqueous solution
- Storage: <-70°C, protected from light - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: MOLTOX, INC., NC 28607, USA (for TA 98, TA 1535 and TA 102) and Xenometrix AG, Switzerland (for TA 100 and TA 1537) - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver microsomal fraction
- Test concentrations with justification for top dose:
- The test item was dissolved in distilled water and diluted prior to treatment.
The following test concentrations were used: 0.0316, 0.100, 0.316, 1.0, 2.5 and 5.0 µL/plate
The test item concentrations to be applied in the main experiment were chosen according to the results of the pre-experiment (which used test concentrations of 0.0316, 0.100, 0.316, 1.0, 2.5 and 5.0 µL/plate). - Vehicle / solvent:
- - Vehicle/ solvent used: water
- Justification for choice of solvent/vehicle: The solvent was compatible with the survival of the bacteria and the S9 activity. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine: TA 98 and TA 1537 (without S9); 10 µg/plate for TA and 40 µg/plate for TA 1537; 2-aminoanthracene: TA 98, TA 100, TA 1535, TA 1537 and TA 102 (with S9); 2.5 µg/plate and 10 µg/plate for TA 102
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation test - EXPERIMENT I; pre-incubation test - EXPERIMENT II
DURATION
- Preincubation period: 60 minutes at 37°C
- Exposure duration: at least 48 hours at 37°C in the dark
NUMBER OF REPLICATIONS: For each strain and dose level, including the controls, three plates were used.
DETERMINATION OF CYTOTOXICITY
- Method: Cytotoxicity can be detected by a clearing or diminution of the background lawn or a reduction in the number of revertants down to a mutation factor of approximately ≤0.5 in relation to the solvent control. - Evaluation criteria:
- A test item is considered mutagenic if:
- a clear and dose related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs
in at least one trater strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA 98, TA 100 and TA 102 the number of reversions is at least twice as high
- if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher
than the reversion rate of the solvent control. - 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
- Untreated negative controls validity:
- not examined
- 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
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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 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 102
- 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:
- RESULTS: See Tables 5 and 6
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation of the test item was observed in any tester strain used in experiments I and II (with and without metabolic activation).
HISTORICAL CONTROL DATA
- Positive historical control data: See Tables 2 and 4
- Negative historical control data: See Tables 1 and 3
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity: No toxic effects of the test item were noted in any of the five tester strains used up to the highest dose group evaluated with and without metabolic activation in experiment I and II. - Conclusions:
- The test item, Harpin-ab Fermentation Extract is considered to be non-mutagenic.
Reference
Table 1: Historical laboratory control data of the negative control (in 2014 – 2016) without S9
|
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
Mean |
24.2 |
90.7 |
13.8 |
8.2 |
270.4 |
SD |
6.7 |
15.6 |
6.7 |
2.9 |
55.0 |
Min |
11 |
49 |
4 |
3 |
141 |
Max |
58 |
155 |
41 |
35 |
472 |
RSD (%) |
27.7 |
17.2 |
48.6 |
35.3 |
20.3 |
n |
972 |
1191 |
929 |
931 |
682 |
Table 2: Historical laboratory control data of the positive control (in 2014 – 2016) without S9
|
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
Substance Conc/plate |
4-NOPD 10 µg |
NaN3 10 µg |
NaN3 10 µg |
4-NOPD 40 µg |
MMS 1 µL |
Mean |
430.7 |
612.1 |
792.0 |
94.5 |
1729.2 |
SD |
155.5 |
220.0 |
299.5 |
22.7 |
518.8 |
Min |
141 |
132 |
38 |
35 |
272 |
Max |
1830 |
1423 |
1854 |
273 |
3321 |
RSD (%) |
36.1 |
35.9 |
37.8 |
24.0 |
30.0 |
n |
971 |
1188 |
931 |
929 |
682 |
Table 3: Historical laboratory control data of the negative control (in 2014 – 2016) with S9
|
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
Mean |
29.0 |
96.4 |
10.5 |
8.3 |
339.7 |
SD |
6.8 |
14.1 |
4.5 |
3.1 |
71.3 |
Min |
15 |
62 |
3 |
3 |
157 |
Max |
59 |
160 |
38 |
36 |
586 |
RSD (%) |
23.4 |
14.6 |
42.7 |
37.4 |
21.0 |
n |
967 |
1189 |
925 |
926 |
676 |
Table 4: Historical laboratory control data of the positive control (in 2014 – 2016) with S9
|
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
Substance Conc/plate |
2-AA 2.5 µg |
2-AA 2.5 µg |
2-AA 2.5 µg |
2-AA 2.5 µg |
2-AA 10 µg |
Mean |
1880.5 |
1727.0 |
133.9 |
234.1 |
801.2 |
SD |
708.5 |
522.0 |
134.9 |
101.4 |
223.7 |
Min |
70 |
169 |
22 |
26 |
137 |
Max |
3606 |
3132 |
1954 |
682 |
3588 |
RSD (%) |
37.7 |
30.2 |
100.8 |
43.3 |
27.9 |
n |
966 |
1184 |
927 |
925 |
678 |
Table 5: Results Experiment I (plate incorporation test):
Treatment |
Dose/plate |
Revertant colonies per plate |
Mutation factor |
||||
Without S9 |
With S9 |
||||||
Mean |
SD |
Mean |
SD |
-S9 |
+S9 |
||
TA 98 |
|||||||
Water |
- |
33 |
7.9 |
26 |
9.3 |
1.0 |
1.0 |
Test item |
0.0316 µL |
31 |
4.9 |
24 |
7.9 |
0.9 |
0.9 |
Test item |
0.100 µL |
34 |
4.7 |
32 |
2.5 |
1.0 |
1.2 |
Test item |
0.316 µL |
31 |
4.2 |
31 |
3.5 |
0.9 |
1.2 |
Test item |
1.0 µL |
29 |
7.4 |
30 |
8.2 |
0.9 |
1.2 |
Test item |
2.5 µL |
37 |
2.6 |
28 |
4.5 |
1.1 |
1.1 |
Test item |
5.0 µL |
33 |
1.5 |
32 |
3.6 |
1.0 |
1.2 |
4-NOPD |
10 µg |
480 |
16.0 |
- |
- |
14.6 |
- |
2-AA |
2.5 µg |
- |
- |
1656 |
170.0 |
- |
64.5 |
TA 100 |
|||||||
Water |
- |
96 |
10.4 |
92 |
8.5 |
1.0 |
1.0 |
Test item |
0.0316 µL |
93 |
2.5 |
103 |
23.8 |
1.0 |
1.1 |
Test item |
0.100 µL |
98 |
1.2 |
91 |
1.0 |
1.0 |
1.0 |
Test item |
0.316 µL |
80 |
11.0 |
101 |
3.6 |
0.8 |
1.1 |
Test item |
1.0 µL |
99 |
17.0 |
109 |
13.2 |
1.0 |
1.2 |
Test item |
2.5 µL |
95 |
7.2 |
102 |
5.2 |
1.0 |
1.1 |
Test item |
5.0 µL |
111 |
17.0 |
104 |
14.0 |
1.2 |
1.1 |
NaN3 |
10 µg |
891 |
6.7 |
- |
- |
9.3 |
- |
2-AA |
2.5 µg |
- |
- |
1933 |
132.5 |
- |
21.0 |
TA 1535 |
|||||||
Water |
- |
20 |
2.5 |
22 |
1.5 |
1.0 |
1.0 |
Test item |
0.0316 µL |
20 |
2.5 |
20 |
2.5 |
1.0 |
0.9 |
Test item |
0.100 µL |
21 |
1.5 |
20 |
2.5 |
1.0 |
0.9 |
Test item |
0.316 µL |
22 |
2.3 |
21 |
2.6 |
1.1 |
1.0 |
Test item |
1.0 µL |
19 |
2.1 |
22 |
2.6 |
0.9 |
1.0 |
Test item |
2.5 µL |
21 |
2.1 |
19 |
1.0 |
1.0 |
0.9 |
Test item |
5.0 µL |
20 |
1.0 |
22 |
4.4 |
1.0 |
1.0 |
NaN3 |
10 µg |
679 |
18.0 |
- |
- |
33.4 |
- |
2-AA |
2.5 µg |
- |
- |
280 |
18.0 |
- |
12.9 |
TA 1537 |
|||||||
Water |
- |
19 |
4.0 |
20 |
1.2 |
1.0 |
1.0 |
Test item |
0.0316 µL |
21 |
1.5 |
18 |
1.7 |
1.1 |
0.9 |
Test item |
0.100 µL |
19 |
1.5 |
19 |
3.1 |
1.0 |
0.9 |
Test item |
0.316 µL |
21 |
1.7 |
20 |
2.5 |
1.1 |
1.0 |
Test item |
1.0 µL |
20 |
2.6 |
20 |
3.6 |
1.1 |
1.0 |
Test item |
2.5 µL |
19 |
3.5 |
17 |
1.7 |
1.0 |
0.9 |
Test item |
5.0 µL |
19 |
6.1 |
18 |
3.5 |
1.0 |
0.9 |
4-NOPD |
40 µg |
121 |
3.5 |
- |
- |
6.5 |
- |
2-AA |
2.5 µg |
- |
- |
253 |
20.0 |
- |
12.9 |
TA 102 |
|||||||
Water |
- |
357 |
20.6 |
386 |
8.0 |
1.0 |
1.0 |
Test item |
0.0316 µL |
323 |
30.7 |
369 |
10.4 |
0.9 |
1.0 |
Test item |
0.100 µL |
330 |
10.4 |
389 |
13.1 |
0.9 |
1.0 |
Test item |
0.316 µL |
337 |
19.3 |
395 |
18.3 |
0.9 |
1.0 |
Test item |
1.0 µL |
319 |
20.5 |
363 |
18.6 |
0.9 |
0.9 |
Test item |
2.5 µL |
326 |
15.6 |
377 |
22.8 |
0.9 |
1.0 |
Test item |
5.0 µL |
360 |
23.7 |
376 |
2.3 |
1.0 |
1.0 |
MMS |
1 µL |
2195 |
438.2 |
- |
- |
6.2 |
- |
2-AA |
10 µg |
- |
- |
908 |
161.7 |
- |
2.4 |
Table 6: Results Experiment II (Pre-incubation test):
Treatment |
Dose/plate |
Revertant colonies per plate |
Mutation factor |
||||
Without S9 |
With S9 |
||||||
Mean |
SD |
Mean |
SD |
-S9 |
+S9 |
||
TA 98 |
|||||||
Water |
- |
20 |
3.6 |
27 |
2.5 |
1.0 |
1.0 |
Test item |
0.0316 µL |
25 |
4.0 |
46 |
34.5 |
1.2 |
1.7 |
Test item |
0.100 µL |
20 |
4.0 |
25 |
6.5 |
1.0 |
1.0 |
Test item |
0.316 µL |
24 |
2.1 |
21 |
5.5 |
1.2 |
0.8 |
Test item |
1.0 µL |
22 |
6.0 |
31 |
5.1 |
1.1 |
1.2 |
Test item |
2.5 µL |
25 |
4.2 |
30 |
5.0 |
1.2 |
1.1 |
Test item |
5.0 µL |
34 |
1.2 |
28 |
2.3 |
1.7 |
1.0 |
4-NOPD |
10 µg |
735 |
37.4 |
- |
- |
36.8 |
- |
2-AA |
2.5 µg |
- |
- |
1626 |
107.2 |
- |
61.0 |
TA 100 |
|||||||
Water |
- |
124 |
11.5 |
98 |
10.5 |
1.0 |
1.0 |
Test item |
0.0316 µL |
115 |
13.9 |
86 |
1.5 |
0.9 |
0.9 |
Test item |
0.100 µL |
117 |
9.8 |
96 |
9.5 |
0.9 |
1.0 |
Test item |
0.316 µL |
96 |
1.2 |
76 |
3.5 |
0.8 |
0.8 |
Test item |
1.0 µL |
95 |
3.5 |
92 |
7.0 |
0.8 |
0.9 |
Test item |
2.5 µL |
109 |
2.9 |
113 |
7.5 |
0.9 |
1.1 |
Test item |
5.0 µL |
112 |
11.0 |
98 |
10.4 |
0.9 |
1.0 |
NaN3 |
10 µg |
411 |
24.1 |
- |
- |
3.3 |
- |
2-AA |
2.5 µg |
- |
- |
288 |
24.0 |
- |
2.9 |
TA 1535 |
|||||||
Water |
- |
22 |
2.0 |
19 |
1.7 |
1.0 |
1.0 |
Test item |
0.0316 µL |
20 |
2.5 |
19 |
2.5 |
0.9 |
1.0 |
Test item |
0.100 µL |
20 |
1.5 |
19 |
3.0 |
0.9 |
1.0 |
Test item |
0.316 µL |
20 |
7.6 |
19 |
2.1 |
0.9 |
1.0 |
Test item |
1.0 µL |
21 |
2.6 |
21 |
2.6 |
1.0 |
1.1 |
Test item |
2.5 µL |
20 |
1.0 |
19 |
2.0 |
0.9 |
1.0 |
Test item |
5.0 µL |
21 |
5.5 |
18 |
2.0 |
1.0 |
0.9 |
NaN3 |
10 µg |
684 |
82.3 |
- |
- |
31.1 |
- |
2-AA |
2.5 µg |
- |
- |
234 |
25.5 |
- |
12.3 |
TA 1537 |
|||||||
Water |
- |
22 |
1.5 |
19 |
1.0 |
1.0 |
1.0 |
Test item |
0.0316 µL |
23 |
1.5 |
21 |
3.2 |
1.1 |
1.1 |
Test item |
0.100 µL |
19 |
1.0 |
20 |
2.1 |
0.9 |
1.0 |
Test item |
0.316 µL |
22 |
1.5 |
20 |
3.1 |
1.0 |
1.0 |
Test item |
1.0 µL |
21 |
2.3 |
24 |
3.8 |
1.0 |
1.2 |
Test item |
2.5 µL |
22 |
4.0 |
18 |
1.5 |
1.0 |
0.9 |
Test item |
5.0 µL |
21 |
1.7 |
19 |
2.1 |
1.0 |
1.0 |
4-NOPD |
40 µg |
200 |
47.9 |
- |
- |
9.2 |
- |
2-AA |
2.5 µg |
- |
- |
173 |
12.0 |
- |
9.1 |
TA 102 |
|||||||
Water |
- |
280 |
6.1 |
443 |
29.1 |
1.0 |
1.0 |
Test item |
0.0316 µL |
268 |
18.2 |
415 |
12.9 |
1.0 |
0.9 |
Test item |
0.100 µL |
252 |
4.5 |
476 |
27.0 |
0.9 |
1.1 |
Test item |
0.316 µL |
302 |
16.1 |
459 |
38.9 |
1.1 |
1.0 |
Test item |
1.0 µL |
276 |
33.7 |
451 |
21.6 |
1.0 |
1.0 |
Test item |
2.5 µL |
268 |
17.0 |
486 |
14.6 |
1.0 |
1.1 |
Test item |
5.0 µL |
309 |
46.6 |
474 |
10.0 |
1.1 |
1.1 |
MMS |
1 µL |
2167 |
88.3 |
- |
- |
7.7 |
- |
2-AA |
10 µg |
- |
- |
945 |
23.0 |
- |
2.1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
The result of an in vitro gene mutation study in bacteria was negative. Therefore, it is concluded that Harpin-ab Fermentation Extract is not genotoxic and does not warrant classification for mutagenicity in accordance with Regulation (EC) No. 1272/2008.
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.