Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
bristeled coat, squatting posture, irregular respiration, stilted gait, decreased spontaneous activity
Body weight:
not influenced
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.