Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ames assay:

The test chemical has no significant lethal effect on the tester strain TA 98 and TA 100 was observed in the presence or absence of S9 mix at any of the dose levels tested and hence it is not likely to classify as a gene mutant in vitro.

 

In vitro mammalian chromosome aberration study:

The test chemical did not induce chromosome aberration in Chinese hamster cell line in the presence or absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.

 

In vitro mammalian cell gene mutation assay:

The test chemical did not induce gene mutation in Chinese hamster lung cells V79 in the presence or absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journal
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
No significant lethal effect on the tester strain was observed in the presence or absence of S9 mix at any of the dose levels tested.
GLP compliance:
no
Type of assay:
bacterial gene mutation assay
Target gene:
No data available
Species / strain / cell type:
S. typhimurium, other: Salmonella typhimurium TA98 and TA100.
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
The S9 fraction was prepared from the liver of PCB-treated male rats. The S9 mix (0.5 ml) contained 2 Micromoles NADPH, 2.5 micro moles G6P, 4 micro moles MgCl2, and 150 microliter S9 fraction containing 2.5 mg protein
Test concentrations with justification for top dose:
100microgram/plate
Vehicle / solvent:
DMSO
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and experimental conditions:
DURATION
- Preincubation period:
20 min at 37 deg celcius
Evaluation criteria:
Dose response curves
Statistics:
No data available
Species / strain:
S. typhimurium, other: S. typhimurium strain TA98 and TA100.
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
No data available
Remarks on result:
other: No mutagenic potential
Conclusions:
Interpretation of results (migrated information):
negative Negative with and without

No significant lethal effect on the tester strain was observed in the presence or absence of S9 mix at any of the dose levels tested. No of His revertants in TA 98-(Without S9 mix) is 24,and in TA100 is 80. With activation-Without norharman-40, With norharman-69 In the presence of norharman, however, test chemical and exhibited mutagenicity to S.typhimurium TA98 in the presence of S9 mix indicating that norharman was effective only for the frame-shift mutagen.
Executive summary:

Study was conducted to test the effects of the given test chemical on salmonella on two strains TA 98 an TA100 using DMSO as a vehicle. Study is carried out based on Ames test with some modifications. Preincubation is done at 37 deg celcius for 20min.

No significant lethal effect on the tester strain TA 98 and TA 100 was observed in the presence or absence of S9 mix at any of the dose levels tested.

Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data from secondary database
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Mutagenecity testing is done to check the genotoxic effects of the given test chemical.
GLP compliance:
no
Type of assay:
in vitro mammalian chromosome aberration test
Target gene:
No data available
Species / strain / cell type:
Chinese hamster Ovary (CHO)
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Test concentrations with justification for top dose:
50, 160,500µg/ml
Vehicle / solvent:
DMSO
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
not specified
Details on test system and experimental conditions:
No data available
Evaluation criteria:
No data available
Statistics:
No data available
Species / strain:
Chinese hamster Ovary (CHO)
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
Additional information on results:
No data available
Remarks on result:
other: No mutagenic potential
Conclusions:
Interpretation of results (migrated information):
negative Negative with and without

Test chemical did not induce chromosomal aberrations under the given test conditions.
Executive summary:

CHO cells were exposed to the given test chemical in DMSO at concentrations of 50, 160 or 500 μg/mL with and without metabolic activation. Positive and negative controls were included and responded appropriately. No information was provided with respect to observations of cytotoxicity or precipitation.

Test chemical did not induce chromosomal aberrations under the given test conditions

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data from secondary database
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Mutagenecity testing is done to check the genotoxic effects of the given test chemical in Chinese hamster lung cells (V79).
GLP compliance:
no
Type of assay:
mammalian cell gene mutation assay
Target gene:
No data available
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Test concentrations with justification for top dose:
15–275 (–S9)
30-400(+ S9)
Vehicle / solvent:
No data available
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and experimental conditions:
No data available
Evaluation criteria:
No data available
Statistics:
No data available
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not valid
Untreated negative controls validity:
not valid
Positive controls validity:
not valid
Additional information on results:
No data available
Remarks on result:
other: No mutagenic potential
Conclusions:
Interpretation of results (migrated information):
negative Negative with and without

Positive with activation-at 400µg/ml after an 18hr interval. Negative without metabolic activation
Executive summary:

Assay is conducted to test the effects of the given test chemical on chinese hamster lung cells V79.

The concentrations used were15–275 (–S9) ,30-400(+ S9).

Based on the results it was found to be Positive with activation-at 400µg/ml after an 18hr interval and Negative without metabolic activation

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Data available for the test chemical was reviewed to determine the mutagenic nature. The studies are as mentioned below:

 

Ames assay:

 

Ames assay was performed to determine the mutagenic nature of the test chemical. The study was conducted to test the effects of the given test chemical on salmonella on two strains TA 98 and TA100 using DMSO as a vehicle. Study is carried out based on Ames test with some modifications. Preincubation is done at 37° Celsius for 20min. No significant lethal effect on the tester strain TA 98 and TA 100 was observed in the presence or absence of S9 mix at any of the dose levels tested.

 

In another study, Mutagenicity studies were conducted to study the genotoxic ability of the given test chemical on salmonella strains. The dose concentrations used were 25.6, 51.2, 102.4, 204.8, 409.6, 819.2, 1638.4 or 3276.8 μg/plate and the vehicle used is DMSO with positive and negative controls. Cytotoxicity was observed at 3276.8 μg/plate. But no mutagenicity observed.

These studies are supported with another study conducted to determine the genotoxic ability of the given test chemical on salmonella strains. The dose concentrations used were 25.6, 51.2, 102.4, 204.8, 409.6, 819.2, 1638.4 or 3276.8 μg/plate and the vehicle used is DMSO with positive and negative controls. Cytotoxicity was observed at 3276.8 μg/plate. But no mutagenicity observed.

 

Based on the observations made, the test chemical did not induce gene mutation in Salmonella typhimurium strains in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.

 

In vitro mammalian chromosome aberration study:

 

In vitro mammalian chromosome aberration study was performed to determine the mutagenic nature of the test chemical. The study was performed using CHO cells exposed to the given test chemical in DMSO at concentrations of 50, 160 or 500 μg/mL with and without metabolic activation. Positive and negative controls were included and responded appropriately. No information was provided with respect to observations of cytotoxicity or precipitation. Test chemical did not induce chromosomal aberrations under the given test conditions

 

In vitro mammalian cell gene mutation assay:

 

In vitro mammalian cell gene mutation assay was performed to determine the mutagenic nature of the test chemical. The study was conducted to test the effects of the given test chemical on Chinese hamster lung cells V79. The concentrations used were15–275 (–S9), 30-400(+ S9). Based on the results it was found to be Positive with activation-at 400µg/ml after an 18hr interval and Negative without metabolic activation.

 

Based on the data available, the test chemical does not exhibit gene mutation in vitro. Hence it is not likely to classify as a gene mutant in vitro as per the criteria mentioned in CLP regulation.

Justification for classification or non-classification

Based on the data available, the test chemical does not exhibit gene mutation in vitro. Hence it is not likely to classify as a gene mutant in vitro as per the criteria mentioned in CLP regulation.