4-propylcyclohexanone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-09-18 to 1990-01-01

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-propylcyclohexanone

EC Number:

406-810-4

EC Name:

4-propylcyclohexanone

Cas Number:

40649-36-3

Molecular formula:

C9H16O

IUPAC Name:

4-propylcyclohexan-1-one

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Chbb: THOM

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Thomae, Biberach
- Age at study initiation: about 7 to 9 weeks
- Weight at study initiation (mean): 201 (187-220) g
- Housing: They were housed under conventional conditions in a 60 m² room with daylight and artificial fluorescent light (light phase: 6 a.m. - 6 p.m.). The treated rats were kept separately in Makrolon cages type III (floor area: 37.5 x 21 cm - 787.5 cm2, height: 15 cm) on mobile racks. During the acclimatization phase and then for the first 28 hours after start of the treatment, the animals were kept on metal grids (placed above the softwood granulate) and then on conventional softwood granulate as bedding. The cages and the metal grids had been machine-cleaned before the beginning of the study. The bedding was changed three times a week.
- Diet: ad libitum, Altromin Strandard Diet Total Pathogen Free TFF N1324
- Water: tpa water; ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 31 °C
- Humidity (%): 43 to 56%
- Photoperiod: light phase from 6 a.m. - 6 p.m.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: The backs and abdomens of the rats were shaved with an electric hair clipper approximately one hour before treatment.
- Type of wrap: The test material was applied to the shaven, unscarified skin in an area of 6 x 6 cm and covered with tin foil which was kept in place and sealed by a rubber sleeve.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h
After exposure rubber sleeve and tin foil were removed and any remaining test material was wiped off carefully.

TEST MATERIAL
- Amount applied: 2.21 mL/kg
- Constant volume or concentration used: yes

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

yes

Remarks:

The control rats were treated with 20 mL/kg 0.25% aqueous Methocel K 4M Premium solution.

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Behavior and general condition of all rats were checked daily. All rats were weighed before treatment, as well as on days 2, 4, 6, 8, 11, 13 and 15 of the study.
- Necropsy of survivors performed: yes
All the rats were sacrificed at the end of the study by CO2-asphyxia and subjected to gross pathological investigation.

Statistics:

The body weight data were processed by means of the program TOX 511 A, developed by the Department of Technical and Scientific Data Processing of E. Merck, Darmstadt.

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:

All the rats survived the observation period.

Clinical signs:

After removal of the rubber sleeve the rats showed neither intoxication nor local symptoms.

Body weight:

Body weight development of treated and control rats was normal.

Gross pathology:

In the rats which were all sacrificed at the end of the observation period no organ alterations were seen.

Any other information on results incl. tables

On the day of administration general condition and motility of the rats were obviously affected by the method of administration. It was difficult to distinguish between reactions due to fixation by the rubber sleeve and symptoms possibly due to the administration of the test material. Therefore, certain reactions may have been masked.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the result of this study, it is concluded that the test material has no acute toxic potential. The median lethal dose (LD50) for males and females, after an observation period of 15 days, was >2000 mg/kg.

Executive summary:

A study according OECD TG 402 was performed to determine the acute toxicity in rats after epicutaneous administration. The test material was applied undiluted to shaved backs and abdomens of the rats for 24 hours under occlusive conditions. Behavior and general condition of all rats were checked daily. All rats were weighed before treatment, as well as on days 2, 4, 6, 8, 11, 13 and 15 of the study. All the rats were sacrificed at the end of the study by CO2-asphyxia and subjected to gross pathological investigation. In this limit test with 2000 mg/kg bw no animal died and no gross pathology changes were detected. The median lethal dose (LD50) for males and females, after an observation period of 15 days, was > 2000 mg/kg bw.