Registration Dossier

Administrative data

Description of key information

The acute toxicity profile of benzene, mono-C10-13-alkyl derivatives, distillation residues, sulfonated, sodium salt (registered substance/target substance) was not determined by actual acute toxicity studies. Instead, read across substances were used to predict the acute toxicity of the registered substance.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 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.
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.
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 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

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted 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.
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal 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:
Approximately 24 hour prior to topical application of the test material, the hair of each control and treated animal was closely clipped.
A single dose of 2000 mg/kg of the undiluted test material was administered dermally to five male and female animals.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: On day of dosing and day 7 and 14 following dosing.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs observed each day
Statistics:
none, there was no mortallity
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: 95% CL not indicated. LD50 is greater than 2000 mg/kg bw.
Mortality:
Mortality did not occur in treated animals.
Clinical signs:
No clinical signs of toxicity were observed in treated animals.

Body weight:
Significant decreases in bodyweight were observed in treated males on days 2, 7 and 14.
Gross pathology:
Skin irritation was observed for all treated animals. Multiple pinpoint scabs were observed in 3 treated males and 1 treated female.

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

 

Dose
(mg/kg bw)

Conc.
in vehicle (%)*

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

2000

 0/5

 0/5

0/10 

 

 5/5

 5/5

10/10

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Mortality did not occur at doses of 2000 mg/kg bw, therefore an LD50 was not determined.
Executive summary:

In an acute dermal toxicity study, groups of Sprague-Dawley rats (5/sex) were given a single dermal dose of sodium 4-icosylbenzenesulfonate at 2000 mg/kg bw and observed for 14 days.

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

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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
This acute study is classified as acceptable. It satisfies the guideline requirement for an acute dermal study in the rat.

Additional information

An acute rat oral toxicity study conducted on sodium 4-icosylbenzenesulfonate and according to OECD 401 the LD50 was reported to be >5000 mg/kg. In an acute rat dermal toxicity study conducted on sodium 4-icosylbenzenesulfonate and according to OECD 402, the LD50 was reported to be > 2000 mg/kg. No inhalation acute study was available as exposure via this route is unlikely based on vapor pressure of the substance and the unlikely possibility of exposure to aerosols, particles, or droplets of an inhalable size.


Justification for selection of acute toxicity – oral endpoint
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.

Justification for selection of acute toxicity – inhalation endpoint
Human exposure via inhalation is unlikely based on vapor pressure of the substance and the unlikely possibility of exposure to aerosols, particles, or droplets of an inhalable size.

Justification for selection of acute toxicity – dermal endpoint
In an acute dermal toxicity study, groups of Sprague-Dawley rats (5/sex) were given a single dermal dose of sodium 4-icosylbenzenesulfonate at 2000 mg/kg bw and observed for 14 days. No mortality occurred in this limit test, therefore an LD50 has not been determined.

Justification for classification or non-classification

Acute toxicity studies on read across substances of sufficient quality and tested in accordance with standard methodology showed that the acute oral LD50 was > 5000 mg/kg in rats, and the acute dermal LD50 was >2000 mg/kg. The oral LD50 cutoff value for classification is 2000 mg/kg, and the dermal LD50 cutoff value is 2000 mg/kg. Therefore, no classification is required for acute toxicity.