2-butyryl-3-hydroxy-5-thiocyclohexan-3-yl-cyclohex-2-en-1-one

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

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

Test material information

Constituent 1

Reference substance name:

-

EC Number:

425-150-8

EC Name:

-

Cas Number:

94723-86-1

Molecular formula:

C15 H22 O3 S

IUPAC Name:

2-butanoyl-3-hydroxy-5-(thian-3-yl)cyclohex-2-en-1-one

Details on test material:

- Name of test material (as cited in study report): 625-Triketone
- Substance No.: 95/225-1
- Physical state: Powder, beige
- Analytical purity: 99.2 %
- Lot/batch No.: LJ 27881/1
- Date of manufacturing: 18-27 Jul 1995
- Stability under test conditions: guaranteed by the sponsor and verified by reanalysis
- Storage condition of test material: refrigerator

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, FRG
- Strain/Quality: WISTAR / CHBB: THOM (SPF)
- Age at study initiation: young adult animals
- Weight at study initiation: animals of comparable weight; (200 g – 300 g) (± 20% of the mean weight)
- Fasting period before study: 16 hours
- Housing: single housing
- Diet: KLIBA-Labordiaet 343, Klingenthalmuehle AG Kaiseraugst, Switzerland, ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 1 week


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

Analysis of drinking water
The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the technical services of the BASF AG as well as for the presence of germs by a contract laboratory.

Analysis of feed:
The feed used in the study was assayed for chemical and microbial contaminates.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

olive oil

Details on dermal exposure:

TEST SITE
- Area of exposure: clipped epidermis of the dorsal and dorsolateral parts of the trunk
- Application area: about 50 cm²


REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with warm water
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml/kg
- Concentration: 50 g/100 ml
- Constant volume or concentration used: yes

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: twice each workday and once on Saturdays, Sundays and on public holidays
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

SCORING OF SKIN FINDINGS:
Individual readings: 30 - 60 minutes after removal of the semiocclusive dressing (day 1), weekly thereafter and at the end of the study period.

ASSESSMENT OF SKIN FINDINGS:
According to Draize JH (1959): Appraisal of the safety of chemicals in foods, drugs, and cosmetics. The Association of food and drugs officials of the United States, Austin Texas

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths occurred.

Clinical signs:

other: systemic effects no systemic signs of toxicity noted local effects: very slight to well-defined erythema and very slight to slight edema

Gross pathology:

No abnormalities were noted at necropsy.