Tetrahydrothiopyran-3-carboxaldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): 3.4.5.6-Tetrahydro-2H-Thiopyran-3-Carboxyaldehyd
- Substance No.: 84/0242
- Analytical purity: 98 %
- no further data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: young adults
- Weight at study initiation: Animals of comparable weight (+/- 5 % of mean weight)
- Fasting period before study: 16 hours
- Housing: 5 per cage in stainless steel cages
- Diet: Kliba-Labordiaet, Klingenthalmuehle AG, Kaiseraugst, Switzerland ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5 % CMC in water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50.0; 38.3; 26.1; 17.8, 12.1 %, respectively
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: aqueous formulation corresponds to the physiological medium



MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:

5000, 3830, 2610, 1780, 1210 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of signs and symptoms several times on the day of administration at least once each workday; check for moribund and dead animals twice each workday and at least once on weekends and public holidays
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

3 120 mg/kg bw

95% CL:

2 270 - 4 100

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 520 mg/kg bw

95% CL:

3 620 - 8 510

Mortality:

males: 1/5 in the highest dosing group
females: 5/5 in the highest dosing group, 3/5 in the 3830 mg/kg dose group and 2/5 of the 2610 mg/kg dose group
no other deaths occurred

Clinical signs:

male animals: dyspnoea, staggering, apathy, piloerection, exsiccosis, diarrhea, blood in urine, poor general state from day returning to normal within 2 days in surviving animals
female animals: dyspnoea, staggering, abnormal position, atonia, apathy, piloerection, paresis, pain reflex absent, corneal reflex absent, narcotic-like state, exsiccosis, diarrhea, blood in urine, poor general state from day returning to normal within 2 days in surviving animals

Body weight:

nothing abnormal detected

Gross pathology:

Animals that died (male and female):
General congestive hyperemia.
Stomach: isolated cases atonic and empty.
Glandular stomach: reddened.
Intestine: empty and atonic.
Urinary bladder: 1 female animal: questionable bloody ulcerations.

Histopathology of 1 animal that died (female, 5000 mg/kg):
Kidneys: tubulonephrosis and hyperemia.
Urinary bladder: hemorrhages.

Sacrificed animals (male and female):
1210 - 1780 mg/kg:
Organs: no abnormalities detected.

2610 - 5000 mg/kg:
Forestomach: slight thickening of the wall, up to distinctly intensified focal thickening.

Histopathology of 1 sacrificed animal at the end of the study (male, 5000 mg/kg):
Forestomach: partly hyperkeratotic area, partly cicatrized ulcer.