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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Key study: Test method OECD 473. GLP study. Based on a read-across from an analogue substance, the substance "Fatty acids, C14 -22, ethylene esters, bisulfited, sodium salts" is not considered clastogenic in the chromosome aberration test.

Key study: Test method according to OECD 471. GLP Study. Based on a read-across from an analogue substance, the substance "Fatty acids, C14 -22, ethylene esters, bisulfited, sodium salts" is not considered mutagenic in the Ames test to different strains of bacteria.

Key study: Test method according to OECD 490. GLP Study. Based on a read-across from an analogue substance, the substance "Fatty acids, C14 -22, ethylene esters, bisulfited, sodium salts" is not considered mutagenic to mammallian cells in vitro.

Link to relevant study records

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Endpoint:
in vitro gene mutation study in bacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
March 17 - April 23 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across from an analogue substance for which a guideline study (Klimish =1) is available.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format.
Reason / purpose for cross-reference:
read-across source
Key result
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
Key result
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
Key result
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
Key result
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
Key result
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
Positive controls validity:
valid
Remarks on result:
other: Based on a read-across from an analogue substance.
Conclusions:
Based on the read-across approach from the analogue substance Rape oil, bisulfited, sodium salts, the subtance of registration Fatty acids, C14-22, ethlylene esters, bisulfited sodium salts was determined to be non-mutagenic to bacteria in the Ames test.
Executive summary:

An in vitro Ames test was conducted with the analogue substance Rape oil, bisulfited, sodium salts according to OECD guideline 471 under GLP conditions. The test substance did not exhibited mutagenic potential to S. typhimurium strains TA1535, TA1537, TA100, TA98 and E. coli WP2uvr A with and without metabolic activation. Based on the read-across approach, Fatty acids, C14 -22, ethylene esters, bisulfited sodium salts can be considered not mutagenic to bacteria under the conditions described in the assay.

 

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
29 March to 16 July 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across from an analogue substance for which a guideline study (Klimish =1) is available.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format.
Reason / purpose for cross-reference:
read-across source
Key result
Species / strain:
lymphocytes: human
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: Based on a read-across from an analogue substance.
Conclusions:
Based on the read-across approach from the analogue substance "Rape oil, bisulfited, sodium salts", it was concluded that the substance "Fatty acids, C14-22, ethtlene esters, bisuflited, sodium salts" was not clastogenic to human lymphocytes in vitro.
Executive summary:

An in-vitro chromosome aberration test was performed with the analogue substance "Rape oil, bisulfited, sodium salts" in accordance with OECD Guideline 473 under GLP conditions. The analogue

did not induce any statistically significant increases in the frequency of cells with aberrations, in either of two separate experiments, using dose ranges that included a dose level that was limited by the lowest precipitating dose level in the preliminary toxicity test.

The test material was considered to be non-clastogenic to human lymphocytes in vitro. Based on the read-across approach from the analogue substance "Rape oil, bisulfited, sodium salts", it was concluded that the substance "Fatty acids, C14-22, ethtlene esters, bisuflited, sodium salts" was not clastogenic to human lymphocytes in vitro.

 

Endpoint:
in vitro gene mutation study in mammalian cells
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
10 August to 04 October 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across from an analogue substance for which a guideline study (Klimish =1) is available.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
See attached reporting format.
Reason / purpose for cross-reference:
read-across source
Key result
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: Based on a read-across from an analogue substance.
Conclusions:
Based on the read-across approach from the analogue substance "Rape oil, bisulfited, sodium salts", the substance "Fatty acids, C14-22, ethylene esters, bisulfited, sodium salts" was considered to be non-mutagenic to mammallian cells under the experimental conditions described.
Executive summary:

An in-vitro mutation test using Mouse Lymphoma L5178Y Cells was performed with the analogue substance "Rape oil, bisulfited, sodium salt" in accordance with OECD Guideline 476. The test substance did not demonstrate mutagenic potential in this in vitro cell mutation assay. Based on these results, the read-across approach was applied and the substance "Fatty acids, C14-22, ethylene esters, bisulfited, sodium salts" was determined to be non-mutagenic in the in vitro cell mutation assay, under the experimental conditions described.

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 read-across approach, the substance was concluded to be non-mutagenic to bacteria (Ames test) neither to mammalian cells (Mouse Lymphoma Assay) and was also determined to be non-clastogenic (Chromosome aberration test) to human lymphocytes cultured in vitro. Based on these information, the substance is not classified for genotoxicity according to CLP (Regulation (EC) No 1272/2008).