Cyclopentanone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 assurrance 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 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

(only 3 animals were used per dose level)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

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:

TEST ANIMALS:
- Species: COMMON SPECIES: rat
- Strain: RAT STRAINS: Sprague-Dawley
- Sex: male/female
- Source: Harlan Nossan S.r.l., Italy
- Age at study initiation: data not available
- Weight at study initiation: 251 to 274 g (males), 208 to 212 g (females)
- Fasting period before study, housing, diet, water, acclimation period: data not available

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

In-life dates: data not available

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE: (area of exposure, % coverage, type of wrap if used): data not available

REMOVAL OF TEST SUBSTANCE: data not available

TEST MATERIAL: data not available

Duration of exposure:

no data available

Doses:

400 and 2000 mg/kg bw

No. of animals per sex per dose:

3 females (400 mg/kg) and 3 males (2000 mg/kg)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- 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% CL not applicable

Mortality:

At the 400 and 2000 mg/kg bw doses, no mortality occurred

Clinical signs:

other: At the lower dose (400 mg/kg), no clinical signs were observed. At the highest dose (2000 mg/kg), piloerection and staining of skin/fur were observed during period of  exposure and disappeared within 24 hours (See table 1 in the attached document).

Gross pathology:

necropsy after 14 days revealed no abnormalities at the 2 doses.

Any other information on results incl. tables

CYCLOPENTANONE: dermal LD50 (Nunziata A, 1999)

Table 1: Clinical signs and mortality

Dose level	Clinical signs	Mortality
(mg/kg)
2000	Piloerection and staining of skin/fur during period of exposure. Recovery within 24 hours. Necropsy after 14 days revealed no abnormalities.	0/3
400	No clinical signs observed. Necropsy after 14 days revealed no abnormalities.	0/3

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
	112	274	339	65
2000	114	269	343	74
	116	251	320	69
	111	209	221	12
400	113	208	227	19
	115	212	255	43

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

At the 2 tested doses (400 and 2000 mg/kg) no mortality were observed in male and female rats after dermal exposure.

Executive summary:

In an acute dermal toxicity study (Nunziata A, 1999), groups of Sprague-Dawley male and female rats (3/group) were dermally exposed to cyclopentanone (99.8% purity) undiluted at doses of 400 and 2000 mg/kg bw. Animals then were observed for 14 days.

Dermal LD50 for male and female rats was greater than 2000 mg/kg bw. Based on this result, cyclopentanone is not classified for dermal acute toxicity.