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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

No data is available for sucrose benzoate.

Data on benzoic acid used for assessment of the mutagenic potential of sucrose benzoate.

Data on benzoic acid and in vitro mutagenicity has been gathered from the RAC (2012) opinion on the classification of benzoic acid.

Link to relevant study records

Referenceopen allclose all

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
Justification for type of information:
No data exists for genetic toxicity of the target substance sucrose benzoate. The conclusion is therefore based on read across from data on benzoic acid (Since the sodium salt of benzoic acid instantaneously dissociates to the benzoic acid, the studies with sodium benzoate are also representative for benzoic acid). Very limited -if any- absorption can be expected from exposure to sucrose benzoate resulting in lack of systemic toxic potential of non-hydrolised sucrose benzoate. For classification for mutagenicity the substance has to be absorbed in order to reach the cells. Therefore, read-across to data on benzoic acid is considered especially relevant as exposure to sucrose benzoate would not lead to systemic exposure to sucrose benzoate but benzoic acid and sucrose. See also read-across justification attached in section 13.
Reason / purpose for cross-reference:
read-across source
Key result
Species / strain:
S. typhimurium, other: 92, 94, 98, 100, 1535, 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Conclusions:
No data is available for sucrose benzoate. Data on benzoic acid indicate lack of mutagenic potential in bacteria (ECHA/RAC 2012). As a precautious approach read-across from data on benzoic acid is made for assessing the potential for mutagenicity of sucrose benzoate. Thus, based on lack of mutagenic potential of benzoic acid in bacteria a lack of mutagenic potential is to be expected for sucrose benzoate as well. 
Executive summary:

No data is available for sucrose benzoate. Data on benzoic acid indicate lack of mutagenic potential in bacteria (ECHA/RAC 2012). As a precautious approach read-across from data on benzoic acid is made for assessing the potential for mutagenicity of sucrose benzoate. Thus, based on lack of mutagenic potential of benzoic acid in bacteria a lack of mutagenic potential is to be expected for sucrose benzoate as well. 

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
Justification for type of information:
No data exists for genetic toxicity of the target substance sucrose benzoate. The conclusion is therefore based on read across from data on benzoic acid. Read-across from data on benzoic acid is considered especially relevant as exposure to sucrose benzoate would not lead to systemic exposure to sucrose benzoate but benzoic acid and sucrose. See also the read-across justification attached in section 13..
Reason / purpose for cross-reference:
read-across source
Type of assay:
other: Chromosome aberration tests
Species / strain / cell type:
primary culture, other: Chinese hamster cells (CHL)
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
lymphocytes: human
Additional strain / cell type characteristics:
not specified
Metabolic activation:
without
Key result
Species / strain:
primary culture, other: Chinese hamster cell (CHL)
Metabolic activation:
without
Genotoxicity:
positive
Remarks:
ambiguous
Cytotoxicity / choice of top concentrations:
not specified
Key result
Species / strain:
lymphocytes: human
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Conclusions:
No data is available for sucrose benzoate. Therefore read across to benzoic acis is used. Data on benzoic acid indicate a potential for clastogenic effects in mammalian cells (SIDS 2001; ECHA/RAC 2012).
As a precautious approach read-across to data from benzoic acid is made for assessing the potential for mutagenicity of sucrose benzoate. Thus, based on the potential for clastogenic effects in mammalian cells of benzoic acid a similar potential may be expected for sucrose benzoate as well, however, a weaker potential is to be expected due to the low solubility of the substance.
Executive summary:

No data is available for sucrose benzoate.

Data on benzoic acid indicate a potential for clastogenic effects in mammalian cells, as several studies on chromosome aberrations were positive (ECHA/RAC 2012).

As a precautious approach read-across from data on benzoic acid is made for assessing the potential for mutagenicity of sucrose benzoate. Thus, based on the potential for clastogenic effects in mammalian cells of benzoic acid a similar potential may be expected for sucrose benzoate as well, however, a weaker potential is to be expected due to the low solubility of the substance.

Endpoint:
genetic toxicity in vitro, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
No data exists for genetic toxicity of the target substance sucrose benzoate. The conclusion is therefore based on read across from data on benzoic acid (Since the sodium salt of benzoic acid instantaneously dissociates to the benzoic acid, the studies with sodium benzoate are also representative for benzoic acid). Very limited -if any- absorption can be expected from exposure to sucrose benzoate resulting in lack of systemic toxic potential of non-hydrolised sucrose benzoate. For classification for mutagenicity the substance has to be absorbed in order to reach the cells. Therefore, read-across to data on benzoic acid is considered especially relevant as exposure to sucrose benzoate would not lead to systemic exposure to sucrose benzoate but benzoic acid and sucrose. See also read-across justification attached in section 13.
Reason / purpose for cross-reference:
read-across source
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:
not specified
Conclusions:
No data is available for sucrose benzoate. Data on benzoic acid is therefore used for read-across. Data on benzoic acid indicate lack of genotoxic potential in mammalian cells based on negative results in several sister chromatid exhange assays (SIDS (2001); ECHA/RAC 2012).
Executive summary:

No data is available for sucrose benzoate. Data on benzoic acid is therefore used for read-across. Data on benzoic acid indicate lack of genotoxic potential in mammalian cells based on negative results in several sister chromatid exhange assays (SIDS (2001); ECHA/RAC 2012).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (positive)

Genetic toxicity in vivo

Description of key information

No data is available for sucrose benzoate.

Data on benzoic acid is used for assessment of the mutagenic potential of sucrose benzoate. This is considered especially relevant as oral exposure to sucrose benzoate would lead to absorption of benzoic acid/ benzoate due to lack of oral absorption of the non-hydrolised sucrose benzoate.

Data on benzoic acid and in vivo mutagenicity has been gathered from the RAC (2012) opinion on the classification of benzoic acid.

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Type of information:
experimental study
Remarks:
Collection of experimental studies evaluated by ECHA/RAC
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
The study was reviewed by ECHA/RAC in the evaluation of in vivo genetic toxicity of sodium benzoate.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
GLP compliance:
not specified
Type of assay:
other: Bone marrow chromosome aberration test
Species:
rat
Strain:
Sprague-Dawley
Details on species / strain selection:
Bone marrow chromosome aberration tests were performed in rats, whereas Host mediated assay was performed in ICR Mice.
Sex:
male
Route of administration:
oral: gavage
Details on exposure:
Gavage; two groups were exposed, a and b
Duration of treatment / exposure:
a) 6-48 h
b) 6 h
Frequency of treatment:
a) single
dose
b) 5 d
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
50 mg/kg bw/day (nominal)
Dose / conc.:
500 mg/kg bw/day (nominal)
Dose / conc.:
5 000 mg/kg bw/day (nominal)
No. of animals per sex per dose:
5
Key result
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Conclusions:
A bone marrow chromosome aberration test was performed in Sprague Dawley rats exposed to 0. 50. 500 and 5000 mg/kg bw/day of Sodium benzoate by oral gavage for either one singe dose (group a) or for 5 days (group b). Sampling of bone marrow was performed after 6-48 h in group a and 6 h in group b. No signs of mutagenicity was detected.
Executive summary:

A bone marrow chromosome aberration test was performed in Sprague Dawley rats exposed to 0. 50. 500 and 5000 mg/kg bw/day of Sodium benzoate by oral gavage for either one singe dose (group a) of for 5 days (group b). Sampling of bone marrow was performed aafter 6-48 h in group a and 6 h in group b. No signs of mutagenicity was detected.

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
No data exists for genetic toxicity of the target substance sucrose benzoate. The conclusion is therefore based on read across from data on benzoic acid. Read-across from data on benzoic acid is considered especially relevant as exposure to sucrose benzoate would not lead to systemic exposure to sucrose benzoate but benzoic acid and sucrose. See also the read-across justification attached in section 13..
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Conclusions:
No data is available for sucrose benzoate. The results are therefore based on data on benzoic acid. The genotoxicity of benzoic acid in vivo was evaluated by ECHA/RAC 2012.
All the collected in vivo genotoxicity tests were negative at somatic or germ cell level. RAC concludes that on this basis and the negative results obtained in two carcinogenicity studies in rats and mice for sodium benzoate, notwithstanding some limitations, it is very unlikely that benzoic acid would interfere with chromosomes in vivo. The same is therefore concluded for the target substance sucrose benzoate.
Executive summary:

No data is available for sucrose benzoate. The results are therefore based on data on benzoic acid which is considered especially relevant as systemic exposure from oral exposure to sucrose benzoate would be to benzoic acid due to lack of oral absroption og non-hydrolised sucrose benzoate (see 7.1 toxicokinetics) . The genotoxicity of benzoic acid in vivo was evaluated by ECHA/RAC 2012.

All the collected in vivo genotoxicity tests were negative at somatic or germ cell level. RAC concludes that on this basis and the negative results obtained in two carcinogenicity studies in rats and mice for sodium benzoate, that it is very unlikely that benzoic acid would interfere with chromosomes in vivo.

The same is therefore concluded for the target substance sucrose benzoate.

Endpoint:
genetic toxicity in vivo, other
Remarks:
Collection of experimental studies on genetic toxicity in vivo, evaluated by ECHA/RAC
Type of information:
experimental study
Remarks:
Collection of experimental studies evaluated by ECHA/RAC
Adequacy of study:
weight of evidence
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
ECHA/RAC has collected a number of studies on in vivo genetic toxicity of sodium benzoate.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
Qualifier:
equivalent or similar to guideline
Guideline:
other: Host mediated assay (S. tyhph. TA 1530)
GLP compliance:
not specified
Species:
rat
Strain:
Sprague-Dawley
Details on species / strain selection:
Bone marrow chromosome aberration tests were performed in rats, whereas Host mediated assay was performed in ICR Mice.
Sex:
male
Route of administration:
oral: gavage
Duration of treatment / exposure:
singe dose or 5 days
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
50 mg/kg bw/day (nominal)
Dose / conc.:
500 mg/kg bw/day (nominal)
Dose / conc.:
5 000 mg/kg bw/day (nominal)
No. of animals per sex per dose:
5-10
Key result
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Conclusions:
The genotoxicity in vivo was evaluated by the ECHA/RAC 2012. Four studies were collected. Bone marrow chromosome aberration test was performed in Sprague Dawley rats and host mediated assays were performed in ICR miice. Animals were exposed to 0. 50. 500 and 5000 mg/kg bw/day of Sodium benzoate by oral gavage for either one singe dose (group a) of for 5 days (group b). All the in vivo genotoxicity tests were negative at somatic or germ cell level and it is therefore concluded that it is very unlikely that
benzoic acid would interfere with chromosomes in vivo.
Executive summary:

The genotoxicity if benzoic acid in vivo was evaluated by the ECHA/RAC 2012. Four studies were collected. Bone marrow chromosome aberration test was performed in Sprague Dawley rats and host mediated assays were performed in ICR miice. Animals were exposed to 0. 50. 500 and 5000 mg/kg bw/day of Sodium benzoate by oral gavage for either one singe dose (group a) of for 5 days (group b). All the in vivo genotoxicity tests were negative at somatic or germ cell level and it is therefore concluded that it is very unlikely that benzoic acid would interfere with chromosomes in vivo.

.

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

Additional information

Justification for classification or non-classification

No in vitro data is available for sucrose benzoate.

Data on benzoic acid in vitro indicate lack of mutagenic potential in bacteria and lack of potential for sister chromatid exchange in mammalian cells. However, several in vitro studies on chromosome aberrations were positive (ECHA/RAC 2012).

In vivo genotoxicity tests were negative in somatic cells and germ cells. From this and from negative results obtained in two carcinogenicity studies in rats and mice exposed to sodium benzoate RAC (2102) concludes that it is very unlikely that benzoic acid would interfere with chromosomes in vivo.

Based on this sucrose benzoate is not considered of concern with respect to mutagenicity. No classification should apply.