Sulfonic acids, C14-17-sec-alkane, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hostapur SAS 93

IUPAC Name:

Hostapur SAS 93

Details on test material:

- Name of test material (as cited in study report): Hostapur SAS 93
- Physical state: waxy solid
- Analytical purity: 100% (93% active = CAS RN 85711-69-9)
- Composition of test material, percentage of components: 100% Hostapur SAS 93
- Isomers composition: n.a.
- Purity test date: 1988-02-23
- Lot/batch No.: 87098
- Expiration date of the lot/batch: 1990-03-01
- Radiochemical purity (if radiolabelling): n.a.
- Specific activity (if radiolabelling): n.a.
- Locations of the label (if radiolabelling): n.a.
- Expiration date of radiochemical substance (if radiolabelling): n.a.
- Stability under test conditions: stability and homogeneity guaranteed
- Storage condition of test material: in darkness at room temperature
- Other:

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoe WISKf (SPF71) in house breeding
- Age at study initiation:
- Weight at study initiation:
- Fasting period before study:
- Housing: Polypropylene boxes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes


ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):


IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 5% and 20%
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: solubility reasons
- Lot/batch no. (if required): 87093
- Purity: 93%


MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg

Doses:

500, 2000 (mg/kg)

No. of animals per sex per dose:

5 male, 5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

500 - 2 000 mg/kg bw

Mortality:

2000 mg/kg = 10/10 (lethality occurred within 24h p.a.)
500 mg/kg = 0/10

Clinical signs:

other: bristeled coat, squatting posture, irregular respiration, stilted gait, decreased spontaneous activity

Gross pathology:

stomach filled with reddish-black mass (haemoccult positiv), intestinal tract filled with reddish mucous (haemoccult positiv), lungs partly filled with
blood

Other findings:

- Organ weights: no data
- Histopathology: no data
- Potential target organs: no indications
- Other observations: not noted

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Harmful if swallowed

Executive summary:

The acute oral toxicity of sec-alkane sulfonate-sodium salts SAS (93%) was investigated in rats using water as vehicle. 5 male and 5 female rats per dose group were administered the test compound by single-dose gavage at dose levels of 500 or 2000 mg/kg body weight. The observation period was 14 days. After administration of 2000 mg/kg body weight all animals died within 24 hours p.a. Fatal intoxicated animals showed the following symptoms: bristled coat, squatting posture, stilted gait, irregular respiration and decreased spontaneous activity. At necropsy the following findings were revealed: stomach full of reddish-black mass (haemoccult positiv), intestinal tract filled with reddish mucous (haemoccult positv), lungs partly filled with blood. After administration of 500 mg/kg body weight no mortalities occurred. Unspecific clinical symptoms (bristled coat, squatting posture, stilted gait) were present up to 24 hours p.a. No clinical symptoms were observed from day 1 until the end of the observation period. Based on the findings of this limit-test the median lethal dosage (LD50) of sec-alkane sulfonate-sodium salts SAS (93%) in rats is between 500 and 2000 mg/kg body weight.