4,4'-thiodiethylene hydrogen -2-octadecenylsuccinate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20th March 1981 - 8th June 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

Not stated but assumed

GLP compliance:

not specified

Remarks:

Unlikely due to the age of the study

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

1

Reference substance name:

4,4'-thiodiethylene hydrogen -2-octadecenylsuccinate

EC Number:

299-434-3

EC Name:

4,4'-thiodiethylene hydrogen -2-octadecenylsuccinate

Cas Number:

93882-40-7

Molecular formula:

C48H86O8S

IUPAC Name:

2-octadecenylsuccinic anhydride, thiodiethanol esterification products

Test material form:

solid

Remarks:

Waxy Solid

Specific details on test material used for the study:

Description: off white, very thick liuid
Density: 0.9981 g/mL at 60-65 oC
Date of Receipt: February 26,1981
Storage: Room temperature

Preparation of Dosing Material Mixture: The test material was warmed to 60-65oC in a water bath to facilitate handling. No mixture was required.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

Number: 35 males (5 per group, 7 groups)
Age: Young adults
Weight: 260-359 g
Equilibration period: 36 Days
Observations: All animals were checked for viability twice daily during the equilibration period. Piror to assignement to sutdy all animals were examined to ascertain suitability for study.

Husbandry
Housing: Group-housed (six/cage) during equilibration. individually housed during study.
Cages: Suspended, stainless stell with wire mesh bottoms
Environmental conditions: Temperature: Monitored twice daily temperature range during study: 71 to 74oF
Humidity: Monitored daily
Light cycle:12 hours light, 12 hours dark
Food: Purina laboratory Rodent Diet, ad libitum
Water: Automatic watering system, ad libitum, Municipal water supply
Identification: Each animal was identified with a monel ear tag bearing a unique number prior to testing
Selection: All animals number from this shipment were placed in random order, using random number table. A separate list was generated for each sex. Animals for study were selecte by following these listes. Any animals considered unsuitable because of poor health or outlying body weights were excluded and tge successding number was used.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

Doses of 1.0, 1.47, 2.15, 3.16, 4.46, 6.81 and 10.0 g/kg

No. of animals per sex per dose:

35 males (5 per group, 7 groups)

Control animals:

no

Details on study design:

Animals were fasted overnight (for approximately 18 hours) prior to dosing. The test material was administered by oral intubation, using a ball-tipped intubation needle. Doses were calculated using pre-fasted body weights.

Experimental evaluation
Viability check: Twice daily
Pbservation of pharmacologic and toxicologic signs: Approximately 1, 2, and 4 hours after dosing and daily thereafter for fourteen days
Bodyweights: Prefast (weights used for calculation of doses)
Postfast (Just prior to dosing)
Day 7 and Day 14

Post Mortem
All animals surviving at termiantion of the observation period (Day 14) were killed by carbon diocide inhalation and examined grossly. All abnormalities were recorded but no tissues were saved.

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

All animal survived at all dose levels

Clinical signs:

other: Nassal discharge, rales, fecal staining and/or soft stool were echibited sporadically by animals at the 1.0 thru 6.81 g/kg dose levels. signs seen during the the twenty-four hours after dosing in animals at the 10.0 g/kg included soft stool, fecal and ur

Gross pathology:

Post-mortem examinations revealed findings similar to those seen in control rats killed by carbon dioxide inhalation in this labortory.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No mortality was observed in any animal tested up to a dose of10000 mg/kg therefore LD50>10000 mg/kg

Executive summary:

All animals survived at all dose levels; therefore the oral LD50 of Substance is greater than 10.0 q/kg. All animals exhibited body weight gains during the fourteen-day post-dose period with no apparent differences between groups. Nasal discharge, rales, fecal staining and/or soft stool were exhibited sporadically by animals at the 1.0 thru 6.81 (1/10 dose levels. Signs seen during the twenty-four hours after dosing in animals at the 10.0 g/kg included soft stool, fecal and urinary staining, nasal discharge, rales, piloerection and hypoactivity. Some animals at dose levels of 2.15 through 6.81 q/kq also exhibited soft stool and/or fecal staining during the first 24 hours. Other signs occured sporadically in single animals. All animals were free of unusual signs from Day 2 through termination of the study (Day 14). Post-mortem examinations revealed findings similar to those seen in control rats killed by carbon dioxide inhalation in this labortory.