Ethylcyclohexane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-01-20 - 1992-04-03

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 401 (Acute Oral 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:

SRI1D or Lot I.D. Number: 7482-9A
Physical State and Appearance: Colorless liquid

Test animals

Species:

rat

Strain:

other: CD(SD)BR VAF/Plus

Sex:

male/female

Details on test animals or test system and environmental conditions:

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
74-75*F. Relative humidity was maintained-at 45-47%.
Diet and Water:
ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

A single dose of the test material was administered by gavage to animals that had been fasted
overnight.

Doses:

2000 mg compound/kg body weight

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

Clinical Observations:
Animals were observed at least three times on the day of dosing (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 (Day 0), Day 7, and Day 14 of the study.

Necrosy:
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: Discolored (light-brown) feces were noted from all animals on the day following dosing.

Gross pathology:

Minimal hyperkeratosis of the non-glandular gastric mucosa. for all males and three of five females.

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)
				I WEEK	2WEEKS
2000	5,5	0,0	—	5 +,5 +	5 +,5 +

*+ =Number of animals gaining weight -=Number of animals losing weight

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material was a gastric irritant as evidenced by hyperkeratosis of the non-glandular gastric mucosa. The acute oral LD50 for this test material was greater than 2000 mg/kg for male and female rats.

Executive summary:

An acute oral toxicity study was conducted in male and female rats administered a single limit dose of 2000 mg/kg of the test material by gavage. Discolored (light-brown) feces were noted from all animals on the day following dosing. No other abnormal clinical signs were observed during the 14-day observation period. No mortality was observed, and all animals

gained weight normally. Treatment-related changes observed at necropsy were limited to minimal hyperkeratosis of the non-glandular gastric mucosa for all males and three of five females. No other treatment-related changes or signs of organ toxicity were noted at necropsy. In the absence of significant gross organ lesions, other than the obvious signs of

gastric irritation, no tissue was collected for histological examination.