Benzenesulfonic acid, methyl-, C20-24 (even numbered) sec-alkyl derivs.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19-11-2013 to 28-02-2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

GLP compliance:

yes (incl. QA statement)

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzene, C10-12-alkyl derivs., distn. residues, sulfonated, sodium salts

EC Number:

295-131-5

EC Name:

Benzene, C10-12-alkyl derivs., distn. residues, sulfonated, sodium salts

Cas Number:

91844-64-3

IUPAC Name:

Benzene, C10-12-alkyl derivs., distn. residues, sulfonated, sodium salts

Constituent 2

Reference substance name:

219-131-5

IUPAC Name:

219-131-5

Test material form:

liquid: viscous

Specific details on test material used for the study:

Test substance name: H220 Na

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Female rats
- Age at study initiation: no data
- Weight at study initiation: averaging 176-189 in weight
- Fasting period before study: no data
- Housing:Animals were marked with ear tag and cage card.
- Diet (e.g. ad libitum): ad libitum, Standard diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period:5 days prior to testing

ENVIRONMENTAL CONDITIONS
- Temperature (°C):18-23°C
- Humidity (%):12-85%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12

IN-LIFE DATES: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test duration was 15 days.

Doses:

550 and 2000 mg/kg. Dose volumes were 0.55 mL/kg and 2 mL/kg based on the assuming RD of 1mL

No. of animals per sex per dose:

4
One animal was dosed at an initial dose, this animal suvived, then 2 additional animals were dosed at 2000mg/kg

Control animals:

no

Details on study design:

Animals were weighed immediately before treatment and at 1, 8 and 15 days. At prior to 30mins, app. 30mins, 4 hours after dosing and then daily thereafter all animals were observed for symptoms of toxicity. Autopsies were conducted at test termination.

Statistics:

LD50 by EPA statistical program

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no mortality

Mortality:

No mortality was observed.

Clinical signs:

No clinical signs were observed at 550 mg/kg or 2000mg/kg.

Body weight:

At 550mg/kg: A weight loss of 4g from day 8 to day 15 was observed for one animal, but overall weight gain from d1 to d15 (42 grams) observed for this animal.
At 2000mg/kg: No change in bw from day 8 to day 15 was observed for one animal,but overall weight gain from d1 to d15 (36 grams) observed for this animal.
No biologically significant effect was seen on BW on day 8 or 15 for all remainig animals.

Gross pathology:

No visible lessions were revealed in the any of animals receiving test article at 550mg/kg or 2000mg/kg.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test material is not toxic to rats following acute oral exposure, with LD50 determined as greater than 2000 mg/kg. Therefore the substance is considered not to be classified

Executive summary:

The test substance was tested in an up- and down- procedure in 4 rats according to OECD guideline 425. The oral LD50 value for this substance was found to be > 2000 mg/kg. No mortality and no visible lessions were revealed in the any of animals receiving test article at 550 mg/kg or 2000 mg/kg.