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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Genetic mutation in vitro;

The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Experimental data from read across chemical have been reviewed to determine the mutagenic nature of 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, reaction products with guanidine hydrochloride N,N'-bis(mixed Ph, tolyl and xylyl) derivs. (71077-14-0).The studies are as mentioned below

The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Ames mutagenicity assay was performed to evaluate the mutagenic nature of the test chemical using the plate incorporation assay. Test chemical was dissolved in sterile double distilled water and was tested at a concentration of 0, 100, 250, 500 and 1000 μg /plate. The plates were inverted within an hour and placed in a dark vented incubator at 37⁰C for 48 hours. Positive controls (for TA97a and TA98, 20 μg/plate nitro phenylene diamine and for TA100, 1.5 μg/plate sodium azide) and negative controls were maintained concurrently for all the experiments. Three plates were used for each set. After 48 hours of incubation, the revertants colonies were counted. Test chemical did not induce gene mutation in Salmonella typhimurium strains TA97a, TA98 and TA100 and hence it is not likely to classify as a gene mutant in vitro. Hence the substance cannot be classified as gene mutant in vitro.

The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for target substance. Genetic toxicity in vitro study was observed for test chemical in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 by plate method.The Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 were exposed at the concentration of 50 and 250µg /plate with and without S9. The criteria we have adopted for scoring a mutagenic response in routine plate tests is that the observed number of revertants exceed twice the background value for that given assay and exceed the 99.9% confidence limit based on our historical controls. The test chemical was plated in the usual fashion at concentrations from 50 pg/plate to 500 pg/plate and then were incubated anaerobically for 16 h before the usual 3-day aerobic incubation. All results with the five tester strains with and without microsomal activation were negative. Therefore the result was considered to be negative (with and without) for test chemical in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 by plate method. Hence the substance cannot be classified as gene mutant in vitro.

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data for the target chemical is summarized based on the structurally similar read across chemicals
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: As mention below
Principles of method if other than guideline:
WoE derived based on the experimental data from structurally and functionally similar read across chemicals for the target chemical.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Target gene:
Histidine
Species / strain / cell type:
S. typhimurium, other: TA97a, TA98 and TA100
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium, other: TA1535, TA100, TA1537, TA1538, and TA98
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
not specified
Metabolic activation:
without
Metabolic activation system:
not specified
Test concentrations with justification for top dose:
1.10, 100, 250, 500 or 1000 μg /plate
2.50 and 250 µg/plate
Vehicle / solvent:
1.Sterile double distilled water
2.water or DMSO
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
.Sterile double distilled water
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other:
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: Ethylmethanesulfonate (5 µl) Methylmethanesulfonate (1 µl) 9-Aminoaeridine (50µl) Nitroquinoline-N-oxide (0.22 pg) Anthragallol ( 50 µ g ) 2-Anthramine (1 µg) Negative control Dithionite
Details on test system and experimental conditions:
1.Details on test system and conditions
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: No data available
- Exposure duration: 48⁰C
- Expression time (cells in growth medium): 48⁰C
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available

SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available

NUMBER OF REPLICATIONS: triplicate

NUMBER OF CELLS EVALUATED: No data available

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available

OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other: No data available

OTHER: No data available

2.METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period:16 hour
- Exposure duration:3 days
- Expression time (cells in growth medium): 3days
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells):

SELECTION AGENT (mutation assays):
SPINDLE INHIBITOR (cytogenetic assays):
STAIN (for cytogenetic assays):

NUMBER OF REPLICATIONS:

NUMBER OF CELLS EVALUATED:

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other:

OTHER EXAMINATIONS:
- Determination of polyploidy:
- Determination of endoreplication:
- Other:

OTHER: Liquid test was also performed .

Rationale for test conditions:
Not specified
Evaluation criteria:
1.Increase in the number of mutagenic revertants
2.The criteria we have adopted for scoring a mutagenic response in routine plate tests is that the observed number of revertants exceed twice the background value for that given assay and exceed the 99.9% confidence limit based on our historical controls.
Statistics:
1,ANOVA test was performed at 0.05 level
2.Mean was observed.
Species / strain:
S. typhimurium, other: TA97a, TA98 and TA100
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
S. typhimurium, other: TA1535, TA100, TA1537, TA1538, and TA98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: No mutagenic effect were observed
Conclusions:
Gene mutation toxicity study for 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, reaction products with guanidine hydrochloride N,N'-bis(mixed Ph, tolyl and xylyl) derivs. (71077-14-0) as predicted using data from read across chemicals for Salmonella typhimurium bacterial strains in the presence and absence of S9 metabolic activation system is negative and hence the chemical is not likely to classify as a gene mutant in vitro.
Executive summary:

Genetic mutation in vitro;

The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Experimental data from read across chemical have been reviewed to determine the mutagenic nature of 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, reaction products with guanidine hydrochloride N,N'-bis(mixed Ph, tolyl and xylyl) derivs. (71077-14-0).The studies are as mentioned below

The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Ames mutagenicity assay was performed to evaluate the mutagenic nature of the test chemical using the plate incorporation assay. Test chemical was dissolved in sterile double distilled water and was tested at a concentration of 0, 100, 250, 500 and 1000 μg /plate. The plates were inverted within an hour and placed in a dark vented incubator at 37⁰C for 48 hours. Positive controls (for TA97a and TA98, 20 μg/plate nitro phenylene diamine and for TA100, 1.5 μg/plate sodium azide) and negative controls were maintained concurrently for all the experiments. Three plates were used for each set. After 48 hours of incubation, the revertants colonies were counted. Test chemical did not induce gene mutation in Salmonella typhimurium strains TA97a, TA98 and TA100 and hence it is not likely to classify as a gene mutant in vitro. Hence the substance cannot be classified as gene mutant in vitro.

The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for target substance. Genetic toxicity in vitro study was observed for test chemical in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 by plate method.The Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 were exposed at the concentration of 50 and 250µg /plate with and without S9. The criteria we have adopted for scoring a mutagenic response in routine plate tests is that the observed number of revertants exceed twice the background value for that given assay and exceed the 99.9% confidence limit based on our historical controls. The test chemical was plated in the usual fashion at concentrations from 50 pg/plate to 500 pg/plate and then were incubated anaerobically for 16 h before the usual 3-day aerobic incubation. All results with the five tester strains with and without microsomal activation were negative. Therefore the result was considered to be negative (with and without) for test chemical in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 by plate method. Hence the substance cannot be classified as gene mutant in vitro.

The data available for the target chemical based on its read across substance and applying weight of evidence 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, reaction products with guanidine hydrochloride N,N'-bis(mixed Ph, tolyl and xylyl) derivs. (71077-14-0) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a 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 mutation in vitro;

The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Experimental data from read across chemical have been reviewed to determine the mutagenic nature of 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, reaction products with guanidine hydrochloride N,N'-bis(mixed Ph, tolyl and xylyl) derivs. (71077-14-0).The studies are as mentioned below

The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Ames mutagenicity assay was performed to evaluate the mutagenic nature of the test chemical using the plate incorporation assay. Test chemical was dissolved in sterile double distilled water and was tested at a concentration of 0, 100, 250, 500 and 1000 μg /plate. The plates were inverted within an hour and placed in a dark vented incubator at 37⁰C for 48 hours. Positive controls (for TA97a and TA98, 20 μg/plate nitro phenylene diamine and for TA100, 1.5 μg/plate sodium azide) and negative controls were maintained concurrently for all the experiments. Three plates were used for each set. After 48 hours of incubation, the revertants colonies were counted. Test chemical did not induce gene mutation in Salmonella typhimurium strains TA97a, TA98 and TA100 and hence it is not likely to classify as a gene mutant in vitro. Hence the substance cannot be classified as gene mutant in vitro

The read across substances share high similarity in structure and functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for target substance. Genetic toxicity in vitro study was observed for test chemical in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 by plate method.The Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 were exposed at the concentration of 50 and 250µg /plate with and without S9. The criteria we have adopted for scoring a mutagenic response in routine plate tests is that the observed number of revertants exceed twice the background value for that given assay and exceed the 99.9% confidence limit based on our historical controls. The test chemical was plated in the usual fashion at concentrations from 50 pg/plate to 500 pg/plate and then were incubated anaerobically for 16 h before the usual 3-day aerobic incubation. All results with the five tester strains with and without microsomal activation were negative. Therefore the result was considered to be negative (with and without) for test chemical in Salmonella typhimurium strain TA1535, TA100, TA1537, TA1538, and TA98 by plate method. Hence the substance cannot be classified as gene mutant in vitro.

 

The data available for the target chemical based on its read across substance and applying weight of evidence 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, reaction products with guanidine hydrochloride N,N'-bis(mixed Ph, tolyl and xylyl) derivs. (71077-14-0) 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 target substance 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, reaction products with guanidine hydrochloride N,N'-bis(mixed Ph, tolyl and xylyl) derivs. (71077-14-0) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.