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Diss Factsheets

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
Results are based on octanethiol which is a shorter alkyl chain version of octadecylmercaptan. As the thiol/mercaptan group is the active functional group then any toxic effects will specifically be due to the terminal thiol/mercaptan group. The alkyl chain just affects the water solubility and does not play a significant biochemical role or toxicological role. That is why the C8 thiol is a very good analogue for the longer chain thiol/mercaptan.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2000

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
GLP compliance:
not specified
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Octane-1-thiol
EC Number:
203-918-1
EC Name:
Octane-1-thiol
Cas Number:
111-88-6
Molecular formula:
C8H18S
IUPAC Name:
octane-1-thiol

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Rearing automatically controlled at a temperature of 22 ± 2 ° C., relative humidity of 55 ± 15%, ventilation at about 12 times / hour, lighting 12 hours / day (7: 00-19: 00) I used.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Daily exposure for 35 days total.
Frequency of treatment:
Daily
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (actual dose received)
Dose / conc.:
50 mg/kg bw/day (actual dose received)
Dose / conc.:
125 mg/kg bw/day (actual dose received)
Dose / conc.:
250 mg/kg bw/day (actual dose received)
Dose / conc.:
500 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
3 males and 3 females per dose.
Control animals:
yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:
Observations made at 0, 3, 7, 14, 21, 28 and 34 days test duration for males
Observations made at 0, 3, 7, 14 prior to mating; 0, 7, 14, 20 gestation period and 0, 4 days lactation period for females
Sacrifice and pathology:
On the 35th day

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
Adverse effects were observed at the 250mg'kg bw dosage which were consistent with changes in organ weight, blood changes, ulceration and thickening of the forestomach and reddening of the spleen.
Mortality:
mortality observed, treatment-related
Description (incidence):
Mortality occurred for the 500mg/kg bw for 1 male and 1 female after 14 days dosing.
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Effects on body weight gain were suppressed at and above 125mg/kg bw administration
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
Decreased food intake was observed at administration at and above 125mg/kg bw.
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
effects observed, treatment-related
Description (incidence and severity):
Water consumption was twice as high as that of the control group in the 250mg/kg bw group.
Ophthalmological findings:
not specified
Haematological findings:
effects observed, treatment-related
Description (incidence and severity):
Enhanced haematopoiesis and hemosiderin deposition.
Clinical biochemistry findings:
effects observed, treatment-related
Description (incidence and severity):
For all males and females, blood collected on the day of dissection was left to stand at room temperature for about 30 minutes and then centrifuged. GOT and GPT (UV-rate method (JSCC improved method)), γGT (γ ALP (ρ-nitrophenyl phosphate substrate method (JSCC modified method)), total bilirubin (enzyme method (BOD method)), urea nitrogen (enzyme-UV (Enzyme method - UV method (HK - G 6 PDH method)), Total cholesterol (Enzyme method (CO - HDAOS method)), Triglyceride (Urease - LEDH method), Creatinine (Creatininase - POD method), Glucose Total protein (Biuret method), albumin (BCG method), A / G ratio (calculated from total protein and albumin), calcium (OCPC method), inorganic phosphorus (GPCO-HDAOS method, glycerin elimination method) Enzymatic method (PNP-XOD-POD method)), sodium, potassium and crawl (ion selective electrode method) were measured using an automatic analyzer (TBA-200FR, Toshiba).
Urinalysis findings:
effects observed, treatment-related
Description (incidence and severity):
6 fresh urine of each dose group was collected before administration on the 33rd day after administration, and pH, protein, glucose, ketone bilirubin, occult blood, occult blood, urobilinogen (test paper method, Martistic: Bayer Medical) were automatically urine Urinary sediment (Sternheimer-Malbin stained specimen) was examined by measurement with an analyzer (Clinitec 100, Bayer Medical). The urine volume was measured using stored urine for about 21 hours and the specific gravity (refraction method) was measured using a urine gravimeter (Yuricon-JE, Atago), sodium potassium (ion selective electrode method), crawl (coulometric titration method) Was measured.
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
On the organ weight, high values ​​of spleen, liver and kidney weight and low value of thymus weight were observed in males and females of 250 mg / kg group.
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
Changes that seemed to be caused by the test substance were found in femoral bone marrow, spleen, thymus, male femoral bone marrow, liver and female adrenal glands and lungs in males and females.
In the forestomach, erosion or ulcer, hyperplasia of squamous epithelium, hyperkeratosis, edema of submucosal tissue, inflammatory cell infiltration was observed in the group of 50 mg / kg or more, and in the 250 mg / kg group it was changed Significant enhancement was observed.

Erythroid extramedullary hematopoiesis in the spleen was significantly enhanced in males and females of the 250 mg / kg group, and congestion was also observed in the same group. In addition, hemosiderin deposition was observed in all sexes of the 250 mg / kg group, which was significantly increased compared to the control group. Hemosiderin was confirmed by blue staining with Berlin Blue stain.

Atrophy of the thymus was observed in males and females of the 250 mg / kg group. The same change was observed in females in the control group, but the expression number increased in the 250 mg / kg group, and therefore it was judged as the influence of the test substance.

An increase in erythroid hematopoietic cells in the femoral bone marrow and a hepatic central lobular hepatocyte hypertrophy were found in males in the 250 mg / kg group and hypertrophy of the adrenal cortical bundle band cells was observed in females of the 250 mg / kg group .

Collected lung foam cells were found in one female of 50 mg / kg group and three females of 250 mg / kg group.

Moderate diffuse seminiferous tubule atrophy in the testes was found only on one side of the 3 males in the 250 mg / kg group, of which 2 cases showed atrophy in the ipsilateral epididymis and the remaining one in the side testicles The upper body was missing. However, the contralateral testicle only had normal or mild localized seminiferous atrophy.

One female in the control group that did not copulate showed spleen granulomatous inflammation, peritoneal inflammatory cell infiltration, inflammatory cell infiltration of the tibia.
Neuropathological findings:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
no effects observed

Effect levels

open allclose all
Key result
Dose descriptor:
NOEL
Effect level:
>= 10 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
body weight and weight gain
food consumption and compound intake
gross pathology
haematology
organ weights and organ / body weight ratios
urinalysis
water consumption and compound intake
Key result
Dose descriptor:
NOAEL
Effect level:
>= 50 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
body weight and weight gain
food consumption and compound intake
food efficiency
gross pathology
haematology
organ weights and organ / body weight ratios
urinalysis

Target system / organ toxicity

Key result
Critical effects observed:
no
Lowest effective dose / conc.:
10 mg/kg bw/day (actual dose received)
System:
gastrointestinal tract
Organ:
stomach

Applicant's summary and conclusion