Ethylcyclohexane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-01-28 - 1992-04-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethylcyclohexane

EC Number:

216-835-0

EC Name:

Ethylcyclohexane

Cas Number:

1678-91-7

Molecular formula:

C8H16

IUPAC Name:

ethylcyclohexane

Test material form:

liquid: volatile

Specific details on test material used for the study:

SRLD or Lot I.D. Number: 7482-9A
Physical State and Appearance: Colorless liquid

Test animals

Species:

rat

Strain:

other: CD(SD)BR VAF/PlusT

Sex:

male/female

Details on test animals or test system and environmental conditions:

Body Weight Range at Dosing (grams): Males = 230 - 254 Females =190 - 202
Housing:
All animals were individually housed in suspended, stainless-steel, mesh cages.
Environmental Conditions:
A photoperiod of 12 hours light from 6 a.m. to 6 p.m. Room temperature was maintained at
71-75*F. Relative humidity was maintained at 45-48%.
Diet and-Water:
ad libitum

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The hair was removed from an area of the dorsal skin with an electric clipper. A single dose of the material was placed in contact with the skin using a fiber pad and an occlusive wrap to hold the test material in place for 24 hours. At the end of the exposure period, the test material was removed with running water.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 of each sex per dose group

Control animals:

no

Details on study design:

Clinical Observations:
Animals were observed during the exposure period (Day 0) and once each workday thereafter for the duration of the experiment (a total of 14 calendar days). Observation included, but was not limited to: examination of the hair, skin, eyes, motor activity, feces, and urine. Animals were checked for mortality on weekend days.

Body Weight Determinations:
Body weights were collected on the day of dosing and one and two weeks after dosing.
Necropsy:
All animals were necropsied at the completion of the 14-day observation period.

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:

none

Clinical signs:

other: No treatment-related abnormal clinical signs were evident at any time during the 14-day observation period.

Gross pathology:

No treatment-related changes or signs of organ toxicity were evident at necropsy. In the absence of significant gross organ lesions, no tissue was
collected for histological examination.

Any other information on results incl. tables

Summary Table

DOSE (mg/kg)	NUMBER OF RATS DOSED (M,F)	NUMBER OF DEATHS (M,F)	TIME OF DEATH	WEIGHT GAIN* (M,F)
				1WEEK	2WEEKS
2000	5,5	0,0	--------	5 +, 5+	5 +, 5+

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal LD50 for this test material was greater than 2000 mg/kg for both sexes.

Executive summary:

A limit dose of 2000 mg/kg was applied to the skin after the hair was removed with an electric clipper. An occlusive wrap was used to hold the test material against the skin for a period of 24 hours, and at the end of exposure, residual test material was washed off with running water.

No treatment-related abnormal clinical signs were evident at any time during the 14-day observation period. On the last day of the observation period, a small wound with a scab was noted on the shoulder of a single male (Rat 745). Since this animal had appeared clinically normal from the day of dosing to Day 13, this wound was not considered related to administration of the test material. No treatment-related changes or signs of organ toxicity were evident at necropsy. In the absence of significant gross organ lesions, no tissue was collected for histological examination. Based on weight gain and survival rate, there was no evidence of percutaneous absorption. The acute dermal LD50 for this test material was greater than 2000 mg/kg for both sexes.