Octane-1-thiol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981-01-21 to 1981-02-10

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study was classified as reliable with restrictions because it was well-documented and generally followed OECD Guidelines 420.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

yes

Remarks:

method of oral application (gavage) was not detailed; highest doses exceed limit test dose; the recommended doses of 5, 50, 300 and 2000 mg/kg were not used

GLP compliance:

yes (incl. QA statement)

Remarks:

UBTL Division, University of Utah Research Institute

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Octane-1-thiol (CAS # 111-88-6)

IUPAC Name:

Octane-1-thiol (CAS # 111-88-6)

Details on test material:

- Name of test material (as cited in study report): Phillips n-octyl mercaptan (Octane-1-thiol)
- Other: UBTL Sample# 80M 05450-3

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Simonson Lab or other reputable animal breeder
- Weight at study initiation: 150 to 300 grams
- Fasting period before study: 1 day
- Housing: individually in either stainless steel cages with screen floors and pans or in polycarbonate boxes using wood shavings for bedding
- Diet (e.g. ad libitum): Wayne's Lab-B, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4 ro 22.7
- Humidity (%): 30 to 60% (median 45%)
- Air changes (per hr): 15 exchanges
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 1981-01-27 To: 1981-02-10

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE: no vehicle

MAXIMUM DOSE VOLUME APPLIED: 3360 mg/kg (4.0 mL/kg)


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

1680, 2100, 2688, or 3360 mg/kg bw (2, 2.5, 3.2, or 4 mL/kg bw)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily during the first 3 days and approximately 24 hours thereafter for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: pharmacological symptoms, body weight, external and internal examination

Statistics:

probit analysis

Results and discussion

Preliminary study:

Results from the preliminary study were not provided.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 436 mg/kg bw

95% CL:

2 108 - 2 831

Remarks on result:

other: 2436 mg/kg bw = 2.9 mL/kg bw

Mortality:

One death at 1680 mg/kg, three deaths at 2100 mg/kg, six deaths at 2688 mg/kg and nine deaths at 3360 mg/kg

Clinical signs:

other: Animals that died prior to sacrifice exhibited lacrimation, bleeding from eyes, and docile behaviour to no activity prior to death.

Gross pathology:

In the first dose level three animals showed abnormal tissue in some of the following tissue: lung, liver, stomach, intestines, kidney, gonads, and ovaries. Eight animals in the second dose level showed abnormalities in some the following tissue: lungs, liver, adrenals, stomach, spleen, kidneys, and intestines. All of the animals in the two highest dose levels showed abnormalities in some of the following tissue: heart, lungs, liver, stomach, spleen, kidneys, intestines, adrenals, esophagus, bladder, and gonad.

Any other information on results incl. tables

Summary of Responses

Dose (mg/kg)	No. of Animals Exposed	No. of Animals that Died	% Mortality
1680	10	1	10
2100	10	3	30
2688	10	6	60
3360	10	9	90

 

 

Mean Body Weights (gm)

Group #	Dose (mg/kg)	No. of Animals Surviving	Fasted	Day 7	Day 14
1	1680	9	176	177	211
2	2100	7	174	163	215
3	2688	4	162	117	140
4	3360	1	171	120	176

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute oral toxicity study, groups of fasted, albino rats (5/sex) were given a single oral dose of octane-1-thiol at doses of 1680, 2100, 2688, or 3360 mg/kg bw and observed for 14 days. The oral LD50 was determined to be 2436 mg/kg bw in males and females. The test material fell outside the range of toxicity categories and was not classified by EU standards.

Executive summary:

In an acute oral toxicity study, groups of fasted, albino rats (5/sex) were given a single oral dose of octane-1-thiol at doses of 1680, 2100, 2688, or 3360 mg/kg bw and observed for 14 days.   

Mortality occurred at all dose levels. There were treatment related clinical signs and necropsy findings at all dose levels. Body weights decreased by day 7 in the three highest dose levels but increased by day 14 at all dose levels for the surviving animals. The oral LD₅₀ was determined to be 2436 mg/kg bw in males and females. The test material fell outside the range of toxicity categories and was not classified by EU standards.

 

This study received a Klimisch score of 2 and was classified as reliable with restrictions because it was well-documented and generally followed OECD Guidelines 420.