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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

No genetic toxicity study with the target substance is available. Data generated with the category substance LABS Na was considered pitoval to this endpoint. The target substance is therefore considered to not be mutagenic.

Link to relevant study records

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Endpoint:
in vitro gene mutation study in bacteria
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
The justification for the read across category approach is included in IU section 13.
Species / strain:
S. typhimurium TA 1535
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
Species / strain:
S. typhimurium TA 1537
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
Species / strain:
S. typhimurium TA 98
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
Species / strain:
S. typhimurium TA 100
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
Species / strain:
S. typhimurium TA 1538
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
Additional information on results:
During the pre-incubation test, signs of toxicity were noted at concentrations as low as 125 µg/plate. No precipitation of the product was observed at any concentration tested.
Conclusions:
No genetic toxicity study with the target substance is available. Data generated with the category substance LABS Na was considered pivotal to this endpoint. The target substance is considered to not be mutagenic.
Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
The justification for the read across category approach is included in IU section 13.
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>= 15 µg/ml with S9, >= 58 µg/ml without S9
Vehicle controls validity:
not examined
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Conclusions:
No geneitic toxicity study with the target substance is available. Data generated with the cateogry substance LABS Na is considered pivotal to this endpoint. LABS NA is not clastogenic in the absence of metabolic activation. THe test substance is also not clastogenic in the presence of metabolic activation at non-cytotoxic concentrations. At cytotoxic xoncentrations, the test substance was weakly clastogenic. The target substance is considered to be not mutagenic.
Endpoint:
in vitro gene mutation study in mammalian cells
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
The justification for the read across category approach is included in IU section 13.
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
preliminary test showed cytotoxicity at >= 50 µg/ml without S9, and >= 100 µg/ml with S9.
Vehicle controls validity:
not examined
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
No genetic toxicity study with the target substance is available. Data generated with the category substance LABS Na is considered pivotal. The target substance is therefore considered to be not mutagenic in either presence or absence of metabolic activation.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

No genetic toxicity study with the target substance is available. Data generated with the category substance LABS Na was considered pitoval to this endpoint. The target substance is therefore considered to not be mutagenic.

Link to relevant study records
Reference
Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
The justification of the read across category approach is included in IU section 13.
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Conclusions:
No genetic toxicity study with thetarget substance is available. Data generated with the category substance LABS Na is considered pivotal. Therefore, the target substance is considered to not be mutagenic.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Genetic toxicity in vitro:

No in vitro genetic toxicity study is available with the target substance. Data generated with the category substance LABS Na were considered pivotal to this endpoint.

Ames: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100 were treated with LABS Na at five dose levels 8, 40, 200, 1000 and 5000 ug/plate, both with and without the addition of S9-mix according to EU Method B.13/14. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation or exposure method. During the pre-incubation test, signs of toxicity were noted at concentrations as low as 125 ug/plate. No precipitation of the product was observed at any concentration tested.

Chromosome aberration: Chinese hamster ovary cells were exposed to concentrations of 0.32 to 78 µg/ml with S9, and 1.25 to 156 µg/ml without S9. Methyl methanesulphonate and cyclophosphamide were used as positive controls. No biologically significant results were seen in treated cultures in the absence of metabolic activation. Positive responses were seen at cytotoxic concentrations in the presence of S9. Concentrations below the level of cytotoxicity with S9 did not show positive results. The test substance is not clastogenic in the absence of metabolic activation, or with metabolic activation below cytotoxic concentrations. These results indicate that LABS Na is weakly clastogenic at cytotoxic concentrations but negative at concentrations below cytotoxic concentrations.

Mammalian cells: A HPRT study examined the potential of LABS Na, to cause mutations in mammalian cells according to OECD guideline 476. Chinese Hamster Ovary (CHO) cells were exposed to concentrations of 0, 0.6, 1, 1.8, 3, and 6 ug/mL without S9, and 0, 6, 10, 18, 30, and 60 ug/mL with S9. The cells were then examined for cytogenicity and mutation frequency. Ethyl methane sulfonate and 3-(20-)methylcholanthrene were used as positive control substances. The test substance was cytogenic at concentrations of 50 ug/ml or greater with metabolic activation, and 100 ug/mL or above without metabolic activation. There was no biologically significant increase in mutation frequency in the treated groups. The test substance is considered not mutagenic to CHO cells both in the presence and absence of S9.

Genetic toxicity in vivo:

No genetic toxicity study in vivo with the target substance is not available. Data generated with LABS Na is considered pivotal to this endpoint. The test substance is observed to be not mutagenic. No significant increases in the number of polychromatic erythrocytes with micronuclei were observed.


Short description of key information:
No study on mutagenic activity is available with the target substance. Data generated with LABS Na was considered pivotal to this endpoint. The target substance is considered to be not mutagenic.

Endpoint Conclusion: not mutagenic

Justification for classification or non-classification

Based on data generated with category substances, the target substance is considered to be not mutagenic and does not need to be classified for genotoxicity.