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Description of key information

The acute toxicity profile of benzene, tetrapropylene-, distn. residues, sulfonated, sodium salts (registered and read across target substance) was not determined by actual acute toxicity studies. Instead, read across source substances were used to predict the acute toxicity of the registered (target) substance. In an acute oral toxicity study (OECD 401), groups of Sprague-Dawley rats (5/sex) were given a single oral dose of sodium 4-icosylbenzenesulfonate at doses of 0 or 5000 mg/kg bw and observed for 14 days. No mortality occurred in this limit test, and the LD50 was reported to be >5000 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Study conducted according to OECD Guidelines and to GLP, but not fully reported. However as this study is used in the context of a read across, Klimisch 2 is assigned.
Justification for type of information:
REPORTING FORMAT FOR THE CATEGORY APPROACH
1. HYPOTHESIS FOR THE CATEGORY APPROACH
The read across follows Scenario 5 - Qualitatively and quantitatively similar effects are caused by a common compound, which is formed from all category members (as described in the 2017 Read-Across Assessment Framework document).
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
TARGET: Benzene, tetrapropylene-, distn. residues, sulfonated, sodium salts
SOURCE: Sodium 4-icosylbenzenesulfonate
3. CATEGORY APPROACH JUSTIFICATION
Linear and non-linear or branched alkylbenzene sulfonates are anionic surfactants with molecules characterized by a hydrophobic (apolar) and a hydrophilic (polar) group. As a group of chemicals, they are generally mixtures of closely related isomers and homologues. Each molecule contains an aromatic ring sulfonated at the para position and attached to either a linear or a branched alkyl chain at any position except the terminal carbons. The sulfonate group is a common functional group present in each of the category members, and is expected to exhibit similar biological activities with little influence from the length of carbon chain. The cation components of the chemicals (e.g. calcium, magnesium, sodium, or barium) are not expected to contribute significantly to the toxicity.
4. DATA MATRIX
See Read Across document attached to CSR
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
None provided in study report.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
Animals were observed for 14 days following administration of the test substance.
Bodyweights were recorded on the day of dosing and at 2, 7 and 14 days after dosing.

Necropsy of survivors performed: yes

Clinical signs were observed and bodyweights measured.
Statistics:
No mortality occurred. Use of statistics not indicated.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000
Remarks on result:
other: 95% CL not indicated. LD50 is greater than 5000 mg/kg bw.
Mortality:
Mortality did not occur in treated animals.
Clinical signs:
Diarrhoea and reduced food intake were observed in one treated female on day one of dosing.
Body weight:
No significant change in bodyweights occurred in treated animals.
Gross pathology:
No treatment related effects were observed on necropsy.

Table 2: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

 

Dose
(mg/kg bw)

Mortality (# dead/total)

Time range of deaths (hours)

Number with evident toxicity (#/total)

Male

Female

Combined

Male

Female

Combined

Control

 0/5

0/5 

0/10

 

0/5

0/5 

0/10

5000

 0/5

0/5

0/10

 

0/5

1/5

0/10

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Mortality did not occur at doses of 5000 mg/kg bw, therefore, and LD50 was not determined.
Executive summary:

In an acute oral toxicity study, groups of Sprague-Dawley rats (5/sex) were given a single oral dose of sodium 4-icosylbenzenesulfonate at doses of  0 or 5000  mg/kg bw and observed for 14 days.

 

No mortality occurred in this limit test, therefore an LD50 has not been determined.

This acute oral study is classified as acceptable. It satisfies the guideline requirement for an acute oral study OECD 401 in the rat. 

Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Study not conducted to guidelines or GLP. However as this study is used in the context of a read across, Klimisch 2 is assigned.
Justification for type of information:
REPORTING FORMAT FOR THE CATEGORY APPROACH
1. HYPOTHESIS FOR THE CATEGORY APPROACH
The read across follows Scenario 5 - Qualitatively and quantitatively similar effects are caused by a common compound, which is formed from all category members (as described in the 2017 Read-Across Assessment Framework document).
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
TARGET: Benzene, tetrapropylene-, distn. residues, sulfonated, sodium salts
SOURCE: Sodium 4-icosylbenzenesulfonate
3. CATEGORY APPROACH JUSTIFICATION
Linear and non-linear or branched alkylbenzene sulfonates are anionic surfactants with molecules characterized by a hydrophobic (apolar) and a hydrophilic (polar) group. As a group of chemicals, they are generally mixtures of closely related isomers and homologues. Each molecule contains an aromatic ring sulfonated at the para position and attached to either a linear or a branched alkyl chain at any position except the terminal carbons. The sulfonate group is a common functional group present in each of the category members, and is expected to exhibit similar biological activities with little influence from the length of carbon chain. The cation components of the chemicals (e.g. calcium, magnesium, sodium, or barium) are not expected to contribute significantly to the toxicity.
4. DATA MATRIX
See Read Across document attached to CSR
Qualifier:
no guideline followed
Principles of method if other than guideline:
Adult albino male Sprague-Dawley rats were fasted for 24 hours, then given a single dose and placed in screen bottom cages with free access to water and laboratory chow for a two week observation period.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20000 mg/kg bw
Doses:
5000, 10000, 20000 mg/kg bw
No. of animals per sex per dose:
6 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
Use of statistics not indicated.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 - < 20 000 mg/kg bw
Remarks on result:
other: 95% CL not indicated
Mortality:
5/6 males died on the third day following dosing, the the 20000 mg/kg bw group.
Clinical signs:
No data.
Body weight:
No data.
Gross pathology:
No data.

Table 2: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

 

Dose
(mg/kg bw)

Mortality (# dead/total)

Time range of deaths (hours)

Number with evident toxicity (#/total)

Male

Female

Combined

Male

Female

Combined

5000

0/6

0/0

0/6

 

unknown

unknown

unknown

 10000 0/6   0/0  0/6    unknown  unknown  unknown
 20000  5/6  0/0  0/6  72  unknown  unknown  unknown
Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Mortality occurred at 20000 mg/kg bw, therefore the LD50 is between 10000 and 20000 mg/kg bw.
Executive summary:

In an acute oral toxicity study, groups of Sprague-Dawley rats (6 males) were given a single oral dose of C14-24 alkaryl calcium salt derivatives at 5000, 10000 or 20000 mg/kg bw and observed for 14 days.

Mortality occurred at 20000 mg/kg bw, therefore the LD50 is between 10000 and 20000 mg/kg bw.

This acute study is classified as acceptable. It satisfies the guideline requirement for an acute oral study in the rat.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
This acute oral study is classified as acceptable. It satisfies the guideline requirement for an acute oral study OECD 401 in the rat. 

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

No acute toxicity studies are available for benzene, tetrapropylene-, distn. residues, sulfonated, sodium salts (read across target substance). However, acute toxicity studies on read across substances are available. Acute toxicity studies on read across source substances of sufficient quality and tested in accordance with standard methodology showed that the acute oral LD50 was > 5000 mg/kg in rats. The oral LD50 cutoff value for classification is 2000 mg/kg, and based on lack of acute toxicity effects, no classification is warranted for the read across target substance, benzene, tetrapropylene-, distn. residues, sulfonated, sodium salts.

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