Tetrahydrothiopyran-3-carboxaldehyde

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of substance: Tetrahydrothiopyran-3-aldehyd
- Substance number: 89/713
- Batch No.: "Aus Fass 72"
- Date of manufacturing: Nov. 1, 1988
- Degree of purity/composition: about 93%
- Physical state/appearance: liquid, achromatic
- Homogeneity of the test substance: the sample appeared to be homogeneous
- Storage stability of the test substance at about 8° C:
- Stability of the test substance preparation(s): the stability of the test substance in olive oil DAB 9 was confirmed by analysis
On completion of all tests the stability of the substance will be verified by a repeated analysis. The result can be obtained from the sponsor (BASF AG)

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
- Strain/quality: SPF-Wistar/Chbb:THOM
- Age at study initiation: 8 weeks
- Weight at study initiation: mean weight males: 245 g; females: 174 g
- Fasting period before study: none
- Housing: single housing
- Diet: Kliba-Labordiaet 343 rat mouse, Klingenthalmuehle AG, Kaiseraugst, Switzerland ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days


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

DRINKING WATER ANALYSIS:
The drinking water is regularly assay for contaminants by the municipal of Frankenthal (Pfalz) and the technical services of BASF AG. In view of the aim and the duration of the study there are no special requirements exceeding the specifications of the drinking water.

FEED ANALYSIS:
The feed used in the study was assayed for contaminants. In view of the aim and the duration of the study the contaminants occurring in commercial feed ought not to influence the results.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 50 cm²
- Type of wrap if used: semiocclusive dressing


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol concentrated and Lutrol diluted to 50 % with water
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.78 ml/kg
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes

REASON FOR THE DOSES:
Based on the physical and chemical characteristics of the test substance no pronounced acute dermal toxicity was expected. Therefore a dose of 2000 mg/kg body weight has been chosen for the study.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: at least once daily, several times on the day of test substance administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

SCORING OF SKIN FINDINGS:
30 - 60 minutes after removal of the semiocclusive dressing and then about one week later and before termination of the study.

PATHOLOGY:
Withdrawal of food about 16 hours before sacrifice with CO2; then necropsy with gross-pathological examination. Necropsy of all animals that die as early as possible.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no deaths occurred

Clinical signs:

slight erythema and edema were noted on day 1 of application.

Body weight:

nothing abnormal detected, normal body weight gain was observed

Gross pathology:

nothing abnormal detected