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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

PETMA is considered non-genotoxic in vitro

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29th June 2021 - 23 July 2021
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
Species / strain / cell type:
S. typhimurium TA 1537
Species / strain / cell type:
S. typhimurium TA 1535
Species / strain / cell type:
S. typhimurium TA 102
Species / strain / cell type:
S. typhimurium TA 100
Species / strain / cell type:
S. typhimurium TA 98
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
5, 15, 50, 150, 1500, 5000 µg/plate (plate incorporation methode)

78, 156, 313, 625, 1250, 2500, 5000µg/plate (preincubation methode)

Concentrations were selected due to strong cytotoxicity at the highest doses, no precipitation observed
Vehicle / solvent:
DMSO
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
benzo(a)pyrene
mitomycin C
other: 4-Nitro-1,2-phenylene diamine and 2-Amino-anthracene
Details on test system and experimental conditions:
NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments: 3

METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): at least 10^9 bacteria/mL (correlating to 100 colonies/plate after dilution)
- Test substance added in agar (plate incorporation); preincubation; in suspension;

TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: 12h
- Exposure duration/duration of treatment: 48h


METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method, e.g.: background growth inhibition
Evaluation criteria:
A result is considered as clearly positive if all following criteria are fulfilled:
• A concentration-related increase, in revertants
• a clear biological relevant increase in at least one concentration compared to the concurrent solvent control
• at least one concentration with an increase above the distribution of historical solvent control data (mean ± 3 SD).

A biologically relevant increase is described as follows:
• if in the bacteria strains TA98, TA100, TA102 the number of revertants is at least twice as high than the reversion rate of the negative controls (increase factor of at least 2.0)
• if in the bacteria strains TA1535 and TA1537 the number of revertants is at least three times higher than the reversion rate of the negative controls (increase factor of at least 3.0).

A test result is considered as clearly negative, if it does not meet the criteria above.
Statistics:
mean values and standard deviations
Key result
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
True 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:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True 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:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True negative controls validity:
not examined
Positive controls validity:
valid
Key result
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
True 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:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True negative controls validity:
not examined
Positive controls validity:
valid
Conclusions:
Based on the results of this study it is concluded that Pentaerythritoltetra (mercaptoacetat) is not mutagenic in the Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 in the presence and absence of metabolic activation under the experimental conditions in this study.
Executive summary:

The test item Pentaerythritoltetra (mercaptoacetat) was tested in the Bacterial reverse mutation assay with five strains of Salmonella typhimurium (TA98, TA100, TA102, TA1535 and TA1537).


The test was performed in three valid experiments in the presence and absence of metabolic activation, with +S9 standing for the presence of a metabolic activation, and -S9 standing for absence of metabolic activation.


The test item showed no precipitates in the tested test item concentrations.


Signs of toxicity towards the bacteria strains could be observed in the highest two test item concentrations and as a result, the first test, following the plate incorportation method, was repeated with additional lower concentrations to achieve at least five non-toxic test item concentrations.


At least five concentrations could be evaluated using the plate incorporation and the pre-incubation method for all bacteria strains with and without metabolic activation.


The results of the experiments showed that none of the tested concentrations induced a relevant or dose-related increase in the number of revertants in all tested strains, in the presence and the absence of metabolic activation.

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

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification