4-(1,4-dioxa-spiro[4.5]dec-8-yl)-cyclohexanone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 December 1997 - 24 December 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

423-860-2

EC Name:

-

Cas Number:

56309-94-5

Molecular formula:

Hill formula: C14H22O3 CAS formula: C14H22O3

IUPAC Name:

4-{1,4-dioxaspiro[4.5]decan-8-yl}cyclohexan-1-one

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl:(WI) BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks
- Weight at study initiation: males: 296 - 312 g, females: 203 - 218 g
- Fasting period before study: not specified
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 50%
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

IN-LIFE DATES: From: To: 10 December 1997 - 24 December 1997

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

propylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: males: 25 cm², females: 18 cm²
- % coverage: 10
- Type of wrap: aluminium foil, Coban elastic bandage (with drops of petrolatum), for females also micropore tape

REMOVAL OF TEST SUBSTANCE
- Washing: tissue with tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 10 mL/kg
- Concentration: 200 mg/mL

Duration of exposure:

24 h

Doses:

2000 mg/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, body weights were recorded on Day 1 pre-administration, 8 and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Males: number of deaths: 0
Females: number of deaths: 0

Clinical signs:

other: No clinical signs of toxicity were observed.

Gross pathology:

No organ abnormalities were found in the animals at macroscopic post mortem examination.

Other findings:

Local skin effects:
Brown staining, scales and focal erythema were seen in the treated skin-areas of the animals during the observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 in rats was determined to be > 2000 mg/kg bw.

Executive summary:

The test item was tested for acute toxicity in rats after dermal administration of 2000 mg/kg bw to 5 male and 5 female animals.

No mortality was observed. Brown staining, scales and focal erythema were seen in the treated skin-areas of the animals during the observation period. Body weight gain was within the expected range.

No abnormalities were found in the animals at necropsy.

The dermal LD50 value in rats was determined to be > 2000 mg/kg bw.