4-pentylcyclohexanone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 18 until October 02, 1990

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:

adopted February 24, 1987

Deviations:

no

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-pentylcyclohexanone

EC Number:

406-670-4

EC Name:

4-pentylcyclohexanone

Cas Number:

61203-83-6

Molecular formula:

C11H20O

IUPAC Name:

4-pentylcyclohexan-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 (188 - 220) g
- Housing: kept separately in Makrolon cages type III
- Diet: ad libitum, Altromin Strandard Diet Total Pathogen Free TFF N1324
- Water: ad libitum, tap water
- Acclimation period: 7days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-31
- Humidity (%): 43-56
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Remarks:

.

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 if used: 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(s) applied: 2.23 mL/kg
- Constant volume or concentration used: yes
- For solids, paste formed: no

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

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: 14 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.

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.

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 and that the LD50 value is higher than 2000 mg/kg bw after dermal application to rats.

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.