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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Homoveratrylamine (120-20-7) was tested for its mutagenic potential in 10 tester strain of Salmonella Typhimurium and E.coli by Bacterial Mutagen Screen on Gradient Plates with Metabolic Activation. The test result was considered to be negative both in the presence and absence of metabolic activation.

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from publication.
Qualifier:
according to guideline
Guideline:
other: As mention below
Principles of method if other than guideline:
To evaluate the mutagenic potential for Homoveratrylamine in 10 tester strain of Salmonella Typhimurium and E.coli by Bacterial Mutagen Screen on Gradient Plates with Metabolic Activation.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Specific details on test material used for the study:
- Name: 2-(3,4-dimethoxyphenyl)ethan-1-amine
- InChI:1S/C10H15NO2/c1-12-9-4-3-8(5-6-11)7-10(9)13-2/h3-4,7H,5-6,11H2,1-2H3
- Smiles:COc1ccc(CCN)cc1OC
- Name of test material: Homoveratrylamine
- Molecular formula :C10H15NO2
- Molecular weight :181.2335 g/mol
- Substance type:organic
Target gene:
Histidine for Salmonella Typhimurium and Tryptophan for E.coli
Species / strain / cell type:
bacteria, other: Salmonella Typhimurium strain D3052, TA1538, TA98, C3076,TA1537, G46, TA1535, and TA100. E.coli WP2, and WP2 uVrA
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
other: R-factor plasmids
Cytokinesis block (if used):
Not specified
Metabolic activation:
with and without
Metabolic activation system:
Adult male Fischer rats live induced with Aroclor 1254 were used to prepare S9 metabolic activation.
Test concentrations with justification for top dose:
1-1000-µg/ml
Vehicle / solvent:
DMSO
Untreated negative controls:
yes
Remarks:
Plates containing no compound are also prepared to serve as negative controls.
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: -S9;streptozotocin +S9;2- acetylaminofluorene
Details on test system and experimental conditions:
Details on test system and conditions
METHOD OF APPLICATION: in agar ( plate incorporation Method)
DURATION
- Exposure duration: 48 hour
NUMBER OF CELLS EVALUATED:

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

NUMBER OF REPLICATIONS:2 plates /concentration
Rationale for test conditions:
Preliminary work on sup plemental tests using additional tester strains has been done. One important objective was to find a Salmonella tester strain more sensitive than either strains.
Evaluation criteria:
Mutagenic concentration range and minimal inhibitory concentration was observed per plates.
Statistics:
Yes
Species / strain:
bacteria, other: Salmonella Typhimurium strain D3052, TA1538, TA98, C3076,TA1537, G46, TA1535, and TA100. E.coli WP2, and WP2 uVrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: No mutagenic effect were observed
Conclusions:
Homoveratrylamine (120-20-7) was tested for its mutagenic potential in 10 tester strain of Salmonella Typhimurium and E.coli by Bacterial Mutagen Screen on Gradient Plates with Metabolic Activation. The test result was considered to be negative both in the presence and absence of metabolic activation.
Executive summary:

Genetic toxicity in vitro study of Homoveratrylamine was assessed for its possible mutagenic potential . For this purpose was Bacterial Mutagen Screen on Gradient Plates method was performed. The advantage of the gradient method is its high capacity. For example, one compound can be evaluated in 10 tester strains over a 10,000-fold concentration range both with and without metabolic activation using only 8 agar plates. The test substance was exposed to S. typhimurium LT-2: G46 (histidine, missense), TA1535 (G46 with gal-bio-uVrB deletion and LPS deletion), TA100 (G46 with gal-bio-uvrB deletion and LPS deletion with the addition of R-factor pKM1O1), C3076 [histidine, (+) frame-shift],TA1537(C3076with gal-bio-uvrB deletion and LPS deletion), D3052 [histidine , (-F) frame-shift], TA1538 (D3052 with gal-bio-uVrB deletion and LPS deletion), and TA98 (D3052 with gal-bio-uvrB deletion and LPS deletion with the addition of A-factor pKM1O1).E.coli : WP2 (E.coli tryptophan) and WP2 uvrA (E. coli tryptophan with uvrA deletion).4 additional strains are used for supple mental testing. These strains are TA92 (G46 with the addition of A-factor pKM1O1), TA94 (D3052 with the addition of R-factor pKM1O1), CM881 (WP2 with the addition of R factor pKM1O1), and CM891 (WP2 with uVrA deletion and with the addition of A-factor pKM1O1) at the concentration of 1-1000-µg/ml. The test substance was exposed in the presence and absence of metabolic activation. No mutagenic effects were observed. Therefore Homoveratrylamine was considered to be non mutagenic in Salmonella Typhimurium strainD3052, TA1538, TA98, C3076,TA1537, G46, TA1535,TA100 and E.coli WP2, WP2 uVrA in thepresence and absence of metabolic activation. Hence the substance cannot be classified as gene mutant in vitro.

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Genetic toxicity In-vitro

Various experimental studies were reviewed to determine the mutagenic nature of target substance Homoveratrylamine (120-20-7). The studies are as mentioned below:

Gene mutation toxicity study was performed by Robert E. McMahon .et al (CANCER RESEARCH, 1979) to determine the mutagenic nature of target substance Homoveratrylamine (120-20-7) using Bacterial strain. Genetic toxicity in vitro study of Homoveratrylamine was assessed for its possible mutagenic potential. For this purpose was Bacterial Mutagen Screen on Gradient Plates method was performed. The advantage of the gradient method is its high capacity. For example, one compound can be evaluated in 10 tester strains over a 10,000-fold concentration range both with and without metabolic activation using only 8 agar plates. The test substance was exposed to S. typhimurium LT-2: G46 (histidine, missense), TA1535 (G46 with gal-bio-uVrB deletion and LPS deletion), TA100 (G46 with gal-bio-uvrB deletion and LPS deletion with the addition of R-factor pKM1O1), C3076 [histidine, (+) frame-shift],TA1537(C3076with gal-bio-uvrB deletion and LPS deletion), D3052 [histidine , (-F) frame-shift], TA1538 (D3052 with gal-bio-uVrB deletion and LPS deletion), and TA98 (D3052 with gal-bio-uvrB deletion and LPS deletion with the addition of A-factor pKM1O1).E.coli : WP2 (E.coli tryptophan) and WP2 uvrA (E. coli tryptophan with uvrA deletion).4 additional strains are used for supple mental testing. These strains are TA92 (G46 with the addition of A-factor pKM1O1), TA94 (D3052 with the addition of R-factor pKM1O1), CM881 (WP2 with the addition of R factor pKM1O1), and CM891 (WP2 with uVrA deletion and with the addition of A-factor pKM1O1) at the concentration of 1-1000-µg/ml. The test substance was exposed in the presence and absence of metabolic activation. No mutagenic effects were observed. Therefore Homoveratrylamine was considered to be non mutagenic in Salmonella Typhimurium strainD3052, TA1538, TA98, C3076,TA1537, G46, TA1535,TA100 and E.coli WP2, WP2 uVrA in the presence and absence of metabolic activation. Hence the substance cannot be classified as gene mutant in vitro.

 

 

In a study functionally similar read across chemical, Gene mutation toxicity study was performed by James C. Ball et al. (Mutation Research, 1984) to determine the mutagenic nature of. The read across substances share high similarity in functional group. Therefore, it is acceptable to derive information on mutation from the analogue substance. Ames Salmonella plate-incorporation assay was performed to determine the mutagenic nature of p-methylbenzyl alcohol. The study was performed on Salmonella typhimurium strain TA100 and TA98 as per the plate incorporation assay. A compound was considered to be mutagenic if the number of revertants/plate exceeded the 99.9% confidence limit and a concentration-dependent increase in the Mutagenicity was observed. The 99.9% confidence limit was 99 revertants above spontaneous revertant levels for TA100 (spontaneous revertants = 196±29 revertants/plate) and 40 revertants above spontaneous revertants for TA98 (spontaneous revertants = 40±12 revertants/plate). p-methylbenzyl alcohol failed to induce mutation in Salmonella typhimurium strain TA100 and TA98 and hence does not classify as a gene mutant in vitro.

 

 

 In a study functionally similar read across chemical, Gene mutation toxicity study was performed by D. Wildet al. (Food and chemical toxicology,1983) to determine the mutagenic nature 4-(4-Methoxyphenyl)butan-2-one (104-20-1). The read across substances share high similarity in functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance. Gene mutation toxicity study was performed to determine the mutagenic nature of 4-(4-Methoxyphenyl)butan-2-one (Anisyl acetone). The study was perfomed as per the standard plate procedure using Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538, TA98 in the presence and absence of S9 metabolic activation system. The test chemical was dissolved in DMSO and used upto doses of 3.6 mg/plate. The plates were incubated for 48 hrs. 4-(4-Methoxyphenyl)butan-2-one (Anisyl acetone) did not induce gene mutation in Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538, TA98, test substance in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant.

Based on the data available for the target chemical and its read across substance and applying weight of evidence Homoveratrylamine (120-20-7) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.

Justification for classification or non-classification

Thus based on the above annotation and CLP criteria for the target chemical Homoveratrylamine (120-20-7) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.