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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ames assay:

The test chemical did not induce reversion of mutation when applied to Salmonella typhim urium strains TA1535, TA100, TA1538, and TA98 in the presence and 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
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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Weight of evidence approach based on the available data of the read-across chemicals.
Justification for type of information:
Weight of evidence approach based on the available data of the 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 mentioned below
Principles of method if other than guideline:
WoE report is based on Gene mutation study for read across chemicals.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Target gene:
2.Histidine
3.Histidine and tryptophan
Species / strain / cell type:
S. typhimurium, other: TA1535, TA100, TA1538 and TA98 bacteria
Additional strain / cell type characteristics:
not specified
Remarks:
2.
Species / strain / cell type:
other: S. typhimurium, other: Salmonella typhimurium TA98, TA100, TA1535, TA1537 bacteria and E. coli WP2 uvr A
Additional strain / cell type characteristics:
not specified
Remarks:
3
Metabolic activation:
with and without
Metabolic activation system:
2. S9 mix was prepared from liver homogenate of rats treated with Aroclor 1254 plus adequate cofactors.
3. Type and composition of metabolic activation system: Liver S9 fraction from Syrian golden hamsters
was used as exogenous metabolic activation system
Test concentrations with justification for top dose:
2. 100, 500 or 1000 µg/plate
3. 42 - 5000 µg/plate without and with S9 mix
The test chemical was freely soluble in deionized water and non toxic in the preliminary toxicity test, it
was tested up to the prescribed maximum concentration of 5000 μg/plate
Vehicle / solvent:
2- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test chemical was soluble in DMSO
3. - Vehicle(s)/solvent(s) used: [none; no data; acetone; arachis oil; beeswax; carbowaxe; castor oil;
cetosteryl alcohol; cetyl alcohol; CMC (carboxymethyl cellulose); coconut oil; corn oil; cotton seed
oil; DMSO; ethanol; glycerol ester; glycolester; hydrogenated vegetable oil; lecithin; macrogel ester;
maize oil; olive oil; paraffin oil; peanut oil; petrolatum; physiol. saline; poloxamer; polyethylene glycol;
propylene glycol; silicone oil; sorbitan derivative; soya oil; theobroma oil; vegetable oil; aqueous
solvents (water or saline or culture medium)] : deionized water
- Justification for choice of solvent/vehicle: The test chemical was freely soluble in deionized water
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
ethylmethanesulphonate
methylmethanesulfonate
other: Hycanthone (TA 1538 and TA 98)
Remarks:
2.
Untreated negative controls:
yes
Remarks:
yes Negative controls were in accordance with the OECD guideline.
Negative solvent / vehicle controls:
yes
Remarks:
Deionized water
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: Positive controls were in accordance with the OECD guideline.
Remarks:
3.
Details on test system and experimental conditions:
2. METHOD OF APPLICATION: soft-agar overlay method

3. NUMBER OF REPLICATIONS:
- Number of cultures per concentration (single, duplicate, triplicate) : triplicates
- Number of independent experiments : 2 individual experiments both in the presence and absence of
S9 mix
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in medium; in agar (plate incorporation); preincubation; in suspension; as
impregnation on paper disk : pre-incubation
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: Pre-incubation method was used with 30 minutes pre-incubation
and at least 48 h incubation time both without and with S9 mix in both experiments
Evaluation criteria:
2. The plates were observed for number of revertants/plate
3. Biological relevant increase in revertant colonies of any of the five tester strains was considered as
positive response
Statistics:
No data available
Species / strain:
S. typhimurium, other: TA1535, TA100, TA1538, and TA98 bacteria
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Remarks:
2.
Species / strain:
other: Salmonella typhimurium TA98, TA100, TA1535, and TA1537 bacteria
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Remarks:
Slight toxicity was exclusively observed in experiment II at the maximum concentration of 5000 μg/plate in TA1535 with S9 mix and TA98 without S9 mix
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True negative controls validity:
not specified
Positive controls validity:
valid
Remarks:
3.
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True negative controls validity:
not specified
Positive controls validity:
valid
Remarks:
3.
Additional information on results:
2. No data
3. RANGE-FINDING/SCREENING STUDIES (if applicable): Test concentrations were based on the leve
l of toxicity in a pre-experiment with all Salmonella and Escherichia strains. Toxicity was evaluated on
the basis of a reduction in the number of revertant colonies and/or a clearing of the bacterial backgr
ound lawn. Since, the test chemical was freely soluble and non toxic in the preliminary toxicity test, it
was tested up to the prescribed maximum concentration of 5000 μg/plate. Precipitation of the test che
mical was not observed. Slight toxicity was exclusively observed in experiment II at the maximum co
ncentration of 5000 μg/plate in TA1535 with S9 mix and TA98 without S9 mix.
Ames test:
- Mean number of revertant colonies per plate and standard deviation: No substantial and biological
relevant increase in revertant colonies of any of the five tester strains was observed in both expe
riments following treatment with the test chemical at any dose level neither in the absence nor in the
presence of metabolic activation.
Remarks on result:
other: No mutagenic potential observed
Conclusions:
The test chemical did not induce reversion of mutation when applied to Salmonella typhimurium strains TA1535, TA100, TA1538, and TA98 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
Executive summary:

Bacterial gene mutation test was performed to evaluate the mutagenic response for the test chemical. The test was performed using Salmonella typhimurium strainsTA1535, TA100, TA1538, and TA98 in the presence and absence of S9 metabolic activation system. The test compound was dissolved in DMSO and used at dose levels of 100, 500 or 1000µg/plate. Concurrent positive control chemicals were also included in the study. The test chemical did not induce reversion of mutation when applied to Salmonella typhimurium strainsTA1535, TA100, TA1538, and TA98 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 another study, The test chemical was investigated for the induction of gene mutations in Salmonella typhimurium and Escherichia coli (Ames test). The study was conducted according to OECD 471 Guidelines. Salmonella typhimurium TA98, TA100, TA1535, and TA1537 and E. coli WP2 uvrA strains were used for the study.Liver S9 fraction from Syrian golden hamsters was used as exogenous metabolic activation system. The test chemical was freely soluble in deionized water. Test concentrations were based on the level of toxicity in a pre-experiment with all Salmonella and Escherichia strains. Toxicity was evaluated on the basis of a reduction in the number of revertant colonies and/or a clearing of the bacterial background lawn. Since, the test chemical was freely soluble and non toxic in the preliminary toxicity test, it was tested up to the prescribed maximum concentration of 5000 μg/plate. Precipitation of the test chemical was not observed. Biological relevant increase in revertant colonies of any of the five tester strains was considered as positive response. 3 replicates in 2 individual experiments both in the presence and absence of S9 mix were used. Pre-incubation method was used with 30 minutes preincubation and at least 48 h incubation time both without and with S9 mix in both experiments. Negative and positive controls were in accordance with the OECD guideline. Slight toxicity was exclusively observed in experiment II at the maximum concentration of 5000 μg/plate in TA1535 with S9 mix and TA98 without S9 mix.No substantial and biological relevant increase in revertant colonies of Salmonella typhimurium TA98, TA100, TA1535, and TA1537 and E. coli WP2 uvrA was observed in both experiments following treatment with the test chemical at any dose level neither in the absence nor in the presence of metabolic activation.Under the experimental conditions, the test chemical was not genotoxic to the bacteria both in the presence and absence of metabolic activation system.

Based on the above studies it can be concluded that the test chemical is not genotoxic to the bacteria both in the presence and absence of metabolic activation system.

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

Additional information

Ames assay:

Bacterial gene mutation test was performed to evaluate the mutagenic response for the test chemical. The test was performed using Salmonella typhimurium strainsTA1535, TA100, TA1538, and TA98 in the presence and absence of S9 metabolic activation system. The test compound was dissolved in DMSO and used at dose levels of 100, 500 or 1000µg/plate. Concurrent positive control chemicals were also included in the study. The test chemical did not induce reversion of mutation when applied to Salmonella typhimurium strainsTA1535, TA100, TA1538, and TA98 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 another study, The test chemical was investigated for the induction of gene mutations in Salmonella typhimurium and Escherichia coli (Ames test). The study was conducted according to OECD 471 Guidelines. Salmonella typhimurium TA98, TA100, TA1535, and TA1537 and E. coli WP2 uvrA strains were used for the study.Liver S9 fraction from Syrian golden hamsters was used as exogenous metabolic activation system. The test chemical was freely soluble in deionized water. Test concentrations were based on the level of toxicity in a pre-experiment with all Salmonella and Escherichia strains. Toxicity was evaluated on the basis of a reduction in the number of revertant colonies and/or a clearing of the bacterial background lawn. Since, the test chemical was freely soluble and non toxic in the preliminary toxicity test, it was tested up to the prescribed maximum concentration of 5000 μg/plate. Precipitation of the test chemical was not observed. Biological relevant increase in revertant colonies of any of the five tester strains was considered as positive response. 3 replicates in 2 individual experiments both in the presence and absence of S9 mix were used. Pre-incubation method was used with 30 minutes preincubation and at least 48 h incubation time both without and with S9 mix in both experiments. Negative and positive controls were in accordance with the OECD guideline. Slight toxicity was exclusively observed in experiment II at the maximum concentration of 5000 μg/plate in TA1535 with S9 mix and TA98 without S9 mix.No substantial and biological relevant increase in revertant colonies of Salmonella typhimurium TA98, TA100, TA1535, and TA1537 and E. coli WP2 uvrA was observed in both experiments following treatment with the test chemical at any dose level neither in the absence nor in the presence of metabolic activation.Under the experimental conditions, the test chemical was not genotoxic to the bacteria both in the presence and absence of metabolic activation system.

Based on the above studies it can be concluded that the test chemical is not genotoxic to the bacteria both in the presence and absence of metabolic activation system.

Justification for classification or non-classification

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