2-(octylthio)ethanol

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study similar to OECD 408. Study did not include clinical biochemistry determinations, ophthalmological examination. Some tissues were not examined such as spinal cord, pituitary, thymus, female mammary glands, and peripheral nerves.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1961

Report date:

1961

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)

Deviations:

yes

Remarks:

See above rationale for reliability

GLP compliance:

not specified

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): Repellent 874
- Name of test material- Repellent 874, Technical Grade, consists of 95 % (based on percent of theoretical sulfur content) or more of 2-hydroxyethyl-n-octyl sulfide and 5 % or less of related compounds-all considered active for labeling purposes by the Environmental Protection Agency.
- Stability under test conditions: Stable under all usual conditions of storage and use. Avoid highly alkaline emulsifiers in emulsion concentrates.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 21 days
- Weight at study initiation: 40-50 g
- Housing: The animals were housed in screen-bottom individual cages.
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

oral: feed

Vehicle:

other: ground commercial laboratory chow, basal ration

Details on oral exposure:

PREPARATION OF DOSING SOLUTIONS:
Test diets were formulated biweekly, or more often as required, and test animals were fed thrice weekly or as required.

DIET PREPARATION
- Rate of preparation of diet (frequency): biweekly or as required.

VEHICLE
- Justification for use and choice of vehicle (if other than water): laboratory diet
- Concentration in vehicle: 0, 0.08, 0.4 and 2.0%

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

13 weeks

Frequency of treatment:

Animals were fed thrice weekly, or as required.

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
0.08, 0.4, and 2%
Basis:
nominal in diet

Doses / concentrations 2

Remarks:

Doses / Concentrations:
74, 368, 1842 mg/kg bw/day
Basis:
other: calculated (see Overall remarks section)

No. of animals per sex per dose:

10

Control animals:

yes, concurrent no treatment

Details on study design:

No data

Examinations

Observations and examinations performed and frequency:

BODY WEIGHT: Yes
- Time schedule for examinations: weekly


FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): yes, calculated as average in grams per group of 10 animals on a weekly basis.


HAEMATOLOGY: Yes
- Time schedule for collection of blood: 4 weeks, 8 weeks and 13 weeks
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: 5 animals per sex per group
- Parameters examined: red blood cell count, white blood cell count, hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils


URINALYSIS: Yes
- Time schedule for collection of urine: 4 weeks, 8 weeks and 13 weeks
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters examined: specific gravity, pH, nitrogen, blood, sugar, and albumin

Sacrifice and pathology:

GROSS PATHOLOGY: Yes, including organ weight measurements (liver, heart, kidney, spleen and gonads)
HISTOPATHOLOGY: Yes, brain, thyroid, larynx, salivary gland, lymph node, lung, heart, liver, kidney, spleen, pancreas, small intestine, colon, stomach, urinary bladder, testes or ovary, uterus, bone and bone marrow.

Results and discussion

Results of examinations

Clinical signs:

not specified

Mortality:

not specified

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

no effects observed

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

no effects observed

Clinical biochemistry findings:

not specified

Urinalysis findings:

no effects observed

Behaviour (functional findings):

not specified

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Histopathological findings: neoplastic:

not specified

Details on results:

BODY WEIGHT AND WEIGHT GAIN
No significant differences found.

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
No significant differences found.

HEMATOLOGY
No significant differences found.

URINALYSIS
No significant differences found.

ORGAN WEIGHTS
No significant differences found.

GROSS PATHOLOGY
No significant differences found.

HISTOPATHOLOGY: NON-NEOPLASTIC
No significant differences found.

HISTOPATHOLOGY: NEOPLASTIC (if applicable)
No significant differences found.

Effect levels

Dose descriptor:

NOEL

Effect level:

>= 2 other: %

Sex:

male/female

Basis for effect level:

other: No observed effects of the test substance present in females or males up to a concentration of 2% of the test substance (top dose evaluated in study).

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

No changes related to treatment with test substance were observed. This lead to the conclusion that under these test conditions, the test substance was not toxic to test animals. NOEL >=2 %.

Executive summary:

In a repeated dose study conducted with methods similar to OECD #408 guidelines, 21-day-old Sprague-Dawley rats (10/sex) were exposed via the diet for 13 weeks to 0, 0.08, 0.4 and 2.0% (estimated to be 74, 368, and 1842 mg/kg/day, respectively) ethanol, 2-(octylthio). The animals were fed 3 times weekly, or as required. Weight and food consumption data were collected weekly. Urinalysis and hematological evaluations were performed at 4, 8 and 13 weeks. Terminal examinations including gross necropsy, organ weight measurements (liver, heart, kidney, spleen and gonads) and histological examination of tissue specimens of the brain, thyroid, larynx, salivary gland, lymph node, lung, heart, liver, kidney, spleen, pancreas, small intestine, colon, stomach, urinary bladder, testes or ovary, uterus, bone and bone marrow were included. No treatment-related effects were observed during the 13-week study or at necropsy for any of the parameters measured; the NOEL was determined to be greater than or equal to 2% (estimated to be 1842 mg/kg/day).