Cyclopentanone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 26-NOV-1998 to 03-SEP-1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The test substance purity was known. The screening protocol was standard, but not validated for GLP by the quality assurance unit.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

(3 animals were used at each dose level)

Principles of method if other than guideline:

other: screening protocol similar to OECD guide-line 401 "acute oral toxicity"

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cyclopentanone

EC Number:

204-435-9

EC Name:

Cyclopentanone

Cas Number:

120-92-3

Molecular formula:

C5H8O

IUPAC Name:

cyclopentanone

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TESTS ANIMALS
- Source: Harlan Nossan S.r.l, Italy
- Age at study initiation: data not available
- Weight at study initiation: 190-203 g (males), 158-169 g (females)
- Fasting period before study: data not available
- Housing, food consumption, water consumption, acclimation period: data not available

ENVIRONMENTAL CONDITIONS (temperature , humidity, air changes, photoperiod): data not available

In-life dates: data not available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: maize oil

Details on oral exposure:

VEHICULE
- Concentration in vehicle: 50 and 200 mg/mL
- Amount of vehicle: 10 mL/kg
- Justification for choice of vehicle: data not available
- Purity: data not available

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION :data not available

Doses:

500 and 2000 mg/kg bw

No. of animals per sex per dose:

3 males (500 mg/kg) and 3 females (2000 mg/kg)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 day
- Frequency of observations and weighing: data not available
- Necropsy of survivors performed: yes

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: 95% Conf. limits: not applicable

Mortality:

no mortality was observed

Clinical signs:

other: Toxic effects were observed: - at 500 and 2000 mg/kg bw, reduced activity, piloerection, hunched posture were observed. - at the lower dose, hair loss was noted following dosing. - at the highest dose, lethargy, part-closed eyes and staining of skin/fu

Gross pathology:

Necropsy showed no abnormalities at 500 and 2000 mg/kg bw doses.

Any other information on results incl. tables

Table 2: body weight changes

Dose level	Animal	Body weight (g) on Day:		Change in body weight
(mg/kg)	Number	1	15	Day 1-15
	182	190	293	103
500	184	195	316	121
	186	203	315	112
	181	159	188	29
2000	183	158	201	43
	185	169	197	28

Table 1: Clinical signs and mortality

Dose level	Clinical signs	Mortality
(mg/kg)
500	Reduced activity, piloerection, hunched posture and hair loss noted following dosing. Recovery within 14 days. Necropsy showed no abnormalities.	0/3
2000	Reduced activity/lethargy, piloerection, hunched posture, part-closed eyes and staining of skin/fur noted following dosing. Recovery within 10 days. Necropsy after 14 days showed no abnormalities.	0/3

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this study, no mortality were observed in rats (males and females) at the 2 administred doses
of cyclopentanone (500 and 2000 mg/kg).

Executive summary:

In an acute oral toxicity study (Nunziata A, 1999), groups of male and female Sprague-Dawley rats (3/group) were given a single oral dose of cyclopentanone (99.8% purity) in maize oil at doses of 500 and 2000 mg/kg bw and observed for 14 days.
Oral LD50 Combined > 2000mg/kg bw (no mortality was observed)

Cyclopentanone is not classified for acute oral toxicity based on the LD50 identify in male and female rats.