Benzenesulfonic acid, mono-C11-13-branched alkyl derivs., calcium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Laboratory study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Branched CaDDBS

IUPAC Name:

Branched CaDDBS

Details on test material:

Calcium bis(tetrapropylenebenzenesulphonate); CAS No. 11117-11-6

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breeding colony
- Age at study initiation: males, approx. 7 weeks; females, approx. 8 weeks
- Weight at study initiation: males mean = 145 g; female mean = 158 g
- Fasting period before study: yes
- Housing: Makrolon Type 4 cages on soft wood granulate in groups of 5 animals in fully air-conditioned rooms
- Diet (e.g. ad libitum): ad libitum, Altromin 1324 rat diet
- Water (e.g. ad libitum): ad libitum, tap water in plastic bottles
- Acclimation period: Approx. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): Not stated
- Photoperiod (hrs dark / hrs light): 12:12 dark:light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

DOSAGE PREPARATION (if unusual): Test material dissolved in the stated concentration in sesame oil and distributed homogeneously by means of a magnetic stirrer. Administered by gavage.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female per dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Symptoms observed twice every day (morning and afternoon) during week and once daily on weekends and holidays. Animals found dead were dissected as soon as possible and examined for macroscopically visible changes. Animals were weighed weekly. At the end of the observatin period surviving animals were sacrificed by CO2 asphyxiation, dissected and examined for macroscopically visible changes.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No effects

Mortality:

No mortality were observed in either male or female rats.

Clinical signs:

other: No clinical signs observed in either male or female rats.

Gross pathology:

No gross pathology signs were observed.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The actue oral LD50 > 2000 mg/kg bw

Executive summary:

An acute oral toxicity study was conducted on Branched CaDDBS (Phenylsulfonat CA) in Wistar rats at a limit dose of 2000 mg/kg bw using both male and female rats. No mortality or other toxic symptoms were observed. No effects on body weight gain were observed. The animals sacrificed at the end of the observation period showed no macroscopically visible changes. The resultant acute oral LD50 is >2000 mg/kg bw.