2-(octylthio)ethanol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

01-1957 to 03-1957

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non standard test method used. Limited information on the test substance, animals tested/environmental conditions. Incomplete examinations performed and only 4 animals used per dose level. Necropsies were not performed on all animals. Non GLP

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1957

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: recommendations outlined by the National Safety Council.

Principles of method if other than guideline:

One-Day Cuff Method used by Draize and associates as modified by Smyth and associates.

GLP compliance:

no

Test type:

other: one-day cuff method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(octylthio)ethanol

EC Number:

222-598-4

EC Name:

2-(octylthio)ethanol

Cas Number:

3547-33-9

Molecular formula:

C10H22OS

IUPAC Name:

2-(octylsulfanyl)ethan-1-ol

Constituent 2

Reference substance name:

Ethanol, 2-(octylthio)-

IUPAC Name:

Ethanol, 2-(octylthio)-

Constituent 3

Reference substance name:

2-hydroxyethyl-n-octyl sulfide

IUPAC Name:

2-hydroxyethyl-n-octyl sulfide

Details on test material:

- Name of test material (as cited in study report): 2-hydroxyethyl-n-octyl sulfide
- Physical state: colorless liquid
- Stability under test conditions: Stable under all usual conditions of storage and use. Avoid highly alkaline emulsifiers in emulsion concentrations.

Test animals

Species:

rabbit

Strain:

other: Albino

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: ~ 2.0 kg

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Entire trunk
- % coverage: 1/10 of the body surface
- Type of wrap if used: impervious plastic film

TEST MATERIAL
- Constant volume or concentration used: no
- Other: The calculated dose of the undiluted test substance was introduced through a catheter.

Duration of exposure:

24 hours

Doses:

7.95 ml/kg, 15.80 ml/kg and 32 ml/kg (estimated to be 7,433, 14,773 and 29,920 mg/kg, respectively based on a density of 0.935 g/cm3 at 15.6 °C)

No. of animals per sex per dose:

4

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes; all fatalities were autopsied to exclude extraneous causes of death. Some survivors were autopsied for gross lesions.
- Other examinations performed: Mortality was monitored for 14 days. After the 24 hour exposure the skin was examined for gross changes.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 15 mL/kg bw

Mortality:

7.95 ml/kg (7,433 mg/Kg) group-1 rabbit died 2 days after dosing.
15.80 ml/kg (14,773 mg/kg) group-1 rabbit died 2 days after dosing and another rabbit died 7 days after dosing.

Clinical signs:

other: The skin of all animals showed slight erythema and slight subcutaneous edema when removed from the dam. Two of the four rabbits in the mid dose group were in a weakened condition. Although the health of the other two rabbits on this dose level seemed sat

Gross pathology:

Autoposies of the fatalities and survivors revealed no significatn findings.

Any other information on results incl. tables

The dose of 32 mL/kg resulted in the volume of fluid exceeding the capacity of the wrap on the dams; therefore, the dosing was discontinued.

Applicant's summary and conclusion

Interpretation of results:

relatively harmless

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The LD50 of the test substance by dermal application, approximated from the available data, was estimated to be 15 ml/kg ( 14,025 mg/Kg).

Executive summary:

In an acute dermal toxicity study that followed the recommendations outlined by the National Safety Council, groups of 4 male albino rabbits weighing about 2.0 kg were placed in two dose groups (7.95 and 15.80 mL/kg, or 7433 and 14773 mg/kg/day, respectively) of ethanol, 2-(octylthio). The fur was closely clipped over the entire trunk (about 1/10 of the body surface) and the dose was retained beneath an impervious plastic film. The calculated dose of the undiluted test substance was introduced through a catheter after the dam was in place. The rabbits were then confined in stocks. The dam was removed after 24 hours’ contact, and the skin was examined for gross changes. Mortality was considered complete after 14 days. All fatalities were autopsied to exclude extraneous causes of death. Some survivors were autopsied for gross lesions. The skin of all animals showed slight erythema and slight subcutaneous edema when removed from the dam. Two of the 4 rabbits in the high dose group were in a weakened condition; 1 died on the second day, and the other survived but failed to gain weight. Although the health of the other 2 rabbits in this group seemed satisfactory, when the dams were removed, their condition subsequently deteriorated. One died on the seventh day; the other survived but lost weight. Autopsies of the fatalities and survivors revealed no significant findings. Although an exact determination of the LD50 could not be made, and approximation from the available data suggested it to be 15 mL/kg or 14,025 mg/kg.