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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In vitro gene mutation study in bacteria (OECD 471, read across structural analogue) - negative


In vitro cytogenicity in mammalian cells (OECD 473, read across structural analogue) - negative


In vitro gene mutation study in mammalian cells (OECD 476, read across structural analogue) - negative

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to Read Across Statement attached in Section 13
Reason / purpose for cross-reference:
read-across source
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Conclusions:
Interpretation of results:
negative with metabolic activation
negative without metabolic activation

Under the present test conditions IBP1-Na, tested up to a cytotoxic concentration, caused no mutagenic effect in the Chinese hamster lung fibroblasts (V79) carried out without and with metabolic activation.
Remark: The test solution contains NaOH due to the production method.

Due to the similarity of the target substance, EP1-Na, and the source substance, IBP1-Na, the result of this study is assessed to be adequate in order to fulfil the requirements of REACH. The read-across approach is further described in the document “Justification of read across from CAS No 53378-51-1 IBP1-Na (source) to CAS No 3338-24-7, EP1-Na (target)” attached in “Point 13 Assessment reports”.
Executive summary:

The test was performed according to the OECD Guideline 476 under GLP compliance. Chinese hamster lung fibroblasts was used as strain. Metabolic activation was used both with and without. Blank, vehicle control and positive control was tested. No genotoxicity, no cytotoxicity was detected.

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to Read Across Statement attached in Section 13
Reason / purpose for cross-reference:
read-across source
Species / strain:
mammalian cell line, other: human peripheral lymphocytes
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
cytotoxicity was noted in the experiment without and with metabolic activation (24-h and 4-h exposure) at 2500 µg IBP1-Na /mL. Haemolysis was noted at the concentration of 2500 µg/mL in both experiments.
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Conclusions:
Interpretation of results:
negative with metabolic activation
negative without metabolic activation

Under the present test conditions, the substance IBP1-Na, tested up to cytotoxic concentrations, in the absence and in the presence of metabolic activation employing two exposure times (without S9) and one exposure time (with S9) revealed no indications of mutagenic properties with respect to chromosomal or chromatid damage.
Remark: the test solution contains NaOH due to the production method.
In the same test, Mitomycin C and cyclophosphamide induced significant damages, which confirmed the validity of this assay.

Due to the similarity of the target substance EP1-Na and the source substance, IBP1-Na, the result of this study is assessed to be adequate in order to fulfill the requirements of REACH. The read-across approach is further described in the document “Justification of read across from CAS No 53378-51-1 IBP1-Na (source) to CAS No 3338-24-7, EP1-Na (target)” attached in “Point 13 Assessment reports”.
Executive summary:

The test was performed according to the OECD guideline 473 under GLP compliance. Human peripheral lymphocytes was used for test. Metabolic activation was used both with and without. Blank, vehicle control and positive control was tested. No genotoxicity was detected, cytotoxicity was noted in the experiment without and with metabolic activation (24-h and 4-h exposure) at 2500 µg test item/mL. Haemolysis was noted at the concentration of 2500 µg/mL in both experiments.

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to Read Across Statement attached in Section 13
Reason / purpose for cross-reference:
read-across source
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no 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:
no 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:
no 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:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Conclusions:
Interpretation of results:
negative with metabolic activation
negative without metabolic activation

Under the present test conditions the substance, IBP1-Na, tested up to a concentration of 5000 µg i-Butyl-dtp-Na/plate, caused no mutagenic effect in the Salmonella typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation.
Remark: the test solution contains NaOH due to the production method.
Executive summary:

The test was performed according to the OECD guideline 471 under GLP compliance. S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 strain were used. Metabolic activation was used both with and without. Vehicle control, blank and positive control was tested. No genotoxicity, no cytotoxicity was detected.

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

Based on the available information on the read-across substance, EP1-Na is not required to be classified for mutagenicity according to Regulation (EC) No 1272/2008.