Benzene, bis(1-methylethyl)-, sulfonated, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12/03/2012-03/05/2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Conducted at a GLP accredited laboratory to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

Sodium diisopropylbenzenesulphonate

EC Number:

248-984-2

EC Name:

Sodium diisopropylbenzenesulphonate

Cas Number:

28348-54-1

Molecular formula:

C12H18O3S.Na

IUPAC Name:

sodium diisopropylbenzenesulfonate

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

- Fasting period before study: overnight

Administration / exposure

Route of administration:

oral: gavage

Details on oral exposure:

14 day were monitored

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 female

Details on study design:

Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of SDIPB at a dose level of 2000 mg/kg bw. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Results and discussion

Preliminary study:

Using available information on the toxicity of the test item, 2000mg/kg was chosen as the starting dose. One rat was dosed once only by gavage. In the absence of toxicity at 2000 mg/kg dose (1.74 ml/kg), a total of five animals were treated at a dose level of 2000 mg/kg in the stduy.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: There were no signs of systemic toxicity.

Other findings:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The acute oral median lethal dose (LD50) of the SDIPB in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw.

Executive summary:

To cover the endpoint acute oral toxicity of substance SDIPB, fixed dose method was applied to female Wistar strain rats according to OECD Guideline 420, and EU method B.1 bis. Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of SDIPB at a dose level of 2000 mg/kg bw. The acute oral median lethal dose (LD50) of the SDIPB in the female Wistar strain rat was estimated to be > 2000 mg/kg bw.

SDIPB should not be classified as acute oral toxicity according to CLP regulation and DSD criteria.