Sodium 4-vinylbenzenesulphonate

Endpoint summary

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

Study period:

14-28 October 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

Test sample, suspended in an appropriate solvent was dosed to test animals by oral gavage. The LD50 was determined according to the Litchfield-Wilcoxon method method. Test procedure is consistent with the requirements of the OECD 401 method.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

mouse

Strain:

ICL-ICR

Sex:

male

Details on test animals or test system and environmental conditions:

The mice were kept in the animal room, where temperature was controlled at 22±0.5 oC and its relative humidity was controlled 60±5%. The mice took solid feed CE-2 (CLEA Japan) and drank tap water ab libium

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

Since sodium p-styrenesulfonate was solid, the test substance was suspended into olive oil to prepare 40 %(w/v) slurry and used for the test.

Doses:

The applied doses were set at 16.00, 13.92, 12.10, 10.52 and 9.14 g/kg

No. of animals per sex per dose:

10 male animals per dose

Control animals:

not specified

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

>= 6 400 mg/kg bw

Based on:

test mat.

Remarks:

A purity correction has been applied to correct for the vehicle content.

Mortality:

Tests were conducted at technically maximum dose levels, 16.00, 13.92, 12.10, 10.52 and 9.14 g/kg at 40% in olive oil, but no mortality of the test animal was observed at any dose levels.

Clinical signs:

Decrease of spontaneous motion and piloerection were observed after treatment, but the symptoms were disappeared in the next day. Dose groups at 16.00, 13.92 and 12.10 g/kg, light diarrhea were observed.

Gross pathology:

At necropsy at the end of test, sodium p-styrenesulfonate treatment group gave no obvious change observations.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Assigning a correction for the content of vehicle, the LD50 of the substance is >6400 mg/kg

Executive summary:

The acute oral toxicity of the substance has been assessed following dosing of male ICR-SLC mice at dose levels upto 16 g/kg with a dose concentration of 40% in olive oil. Correcting for vehicle content, the maximum dose was 6400 mg/kg of test substance. Dosing was conducted by oral gavage using a test method consistent with the classification OECD 401 style of acute oral toxicity testing, but not in compliance with GLP. No mortality was observed upto the maximum dose. The LD50 >6400mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

6 400 mg/kg bw

Quality of whole database:

The data have been accumulated according to a clearly defined test method but not in compliance with GLP.

Acute toxicity: via inhalation route

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

Study period:

7-21 April 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study was conducted to GLP, but according to an older study guideline.

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1100 (Acute Dermal Toxicity)

Principles of method if other than guideline:

40 CFR Part 798

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The exposure sites were prepared by clipping the back of each rabbit. The skin of each rabbit remained intact.
Body surface area = 9cm2.
Test site covered by 1 inch2 gauze and covered by elastic adhesive tape

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 male and 5 female

Control animals:

no

Details on study design:

Observations: 1,2 and 4 hours on Day 1 then twice daily for the following 13 days

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

Erythema in 6 animals from Day 3, reversible within the observation period in 2 animals. Disquamation in 1 animal on Day 9.

Body weight:

No abnormal changes

Gross pathology:

No abnormalities observed in 6 animals. Focal or multi-focal red discolouration in 4 animals plus disquamation in 1 of these 4 animals.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 is >2000 mg/kg.

Executive summary:

The acute dermal toxicity has been assessed by exposure of the substance to 5 male and 5 female New Zealand White rabbits at a dose volume of 2000 mg/kg according to the EPA OTS 798.1100 test method in compliance with GLP. No mortality occurred following single exposure. The dermal LD50 is >2000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Study was conducted to GLP, but according to an older study guideline.

Additional information

Acute Oral Toxicity

The acute oral toxicity of the substance has been assessed following dosing of male ICR-SLC mice at dose levels upto 16 g/kg with a dose concentration of 40% in olive oil. Correcting for vehicle content, the maximum dose was 6400 mg/kg of test substance. Dosing was conducted by oral gavage using a test method consistent with the classification OECD 401 style of acute oral toxicity testing, but not in compliance with GLP. No mortality was observed upto the maximum dose. The LD50 >6400mg/kg.

Acute Dermal Toxicity

The acute dermal toxicity has been assessed by exposure of the substance to 5 male and 5 female New Zealand White rabbits at a dose volume of 2000 mg/kg according to the EPA OTS 798.1100 test method in compliance with GLP. No mortality occurred following single exposure. The dermal LD50 is >2000 mg/kg.

Justification for selection of acute toxicity – oral endpoint

One study is available for this endpoint.  The study assesses the acute oral toxicity of the substance in male mice by oral gavage.

Justification for selection of acute toxicity – dermal endpoint

One study is available for this endpoint.  The study assesses the acute dermal toxicity of the substance in male and female New Zealand white rabbits by dermal exposure to unabraded skin.

Justification for classification or non-classification

Acute Oral Toxicity

No mortality was observed upto the maximum dose. The LD50 >6400mg/kg.

Acute Dermal Toxicity

No mortality was observed upto the maximum dose. The LD50 >2000mg/kg.