4-(trans-4-propylcyclohexyl)acetophenone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19.09.1990 to 03.10.1990

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:

1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-(trans-4-propylcyclohexyl)acetophenone

EC Number:

406-700-6

EC Name:

4-(trans-4-propylcyclohexyl)acetophenone

Cas Number:

78531-61-0

Molecular formula:

Hill formula: C17H24O CAS formula: C17H24O

IUPAC Name:

1-[4-(4-propylcyclohexyl)phenyl]ethan-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
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: about 7 to 9 weeks
- Weight at study initiation: 204 (188 - 220) g
- Fasting period before study: none
- Housing: Makrolon cages type III
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 to 31
- Humidity (%):40 to 56
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 19.09.1990 to 03.10.1990

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

The backs and abdomens of the rats were shaved with an electric hair clipper approximately one hour before treatment. The test material preparation 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 (modified method of NOAKES and SANDERSON, 1969*). The time of occlusive exposure was 24 hours. Then rubber sleeve and tin foil were removed and any remaining test material was wiped off carefully.


Prior to application 4.4 g test item were moistened with 4.4 g aqua pro injectione. From this preparation 4000 mg/kg corresponding to a dose of 2000 mg test item/kg body weight were administered to each rat. The control rats from another study were treated with 20 mL/kg of 0.25 % aqueous solution.

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: clinical signs: at least 6 hours after administration and then checked daily; body weight: on days 2, 4, 6, 8, 11, 13, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality

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 seven of ten rats showed pale eyes on day 2 of the study. No local symptoms were observed.

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.

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study, test substance can be considered to have no acute dermal toxic potential and the expected LD50 value is higher than 2000 mg/kg bw after dermal administration to rats.

Executive summary:

No signs of toxicity were detected in the rats (5 males and 5 females) after treatment with 2000 mg/kg bw according to OECD Guideline 402 under GLP conditions. There were no deaths during the course of the study, so the lethal dose is expected to be higher than the limit dose tested. The body weight development was inconspicuous and the gross pathological examination revealed no organ alterations. Based on the results of this study, test substance can be considered to have no acute toxic potential and the expected LD50 value is higher than 2000 mg/kg bw after dermal administration to rats.