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Toxicological information

Acute Toxicity: oral

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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

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.