2-chlorocyclododecanone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 12, 1999 to November 29, 1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Principles of method if other than guideline:

An acute oral toxicity test carried out on two groups of three young adult rats (three males and three females) at a dose level of 10.0 mls/kg body weight. A further group of ten rats (five male and five female) was treated at the highest dose causing no deaths in the range-finding study .

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Chlorocyclododecanone

IUPAC Name:

Chlorocyclododecanone

Test material form:

other: solid

Details on test material:

Name of test material (as cited in study report): Chlorocyclododecanone

Test animals

Species:

rat

Strain:

other: HanIbm: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals
Young adult HanIbm: WIST (SPF) rats supplied by RCC Ltd,. Biotechnology & Animal Breeding Division, CH-4414 Fullinsdorf, Switzerland.

Husbandry
The animals were housed in groups of three in Makrolon type-4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4303 Muttenz). The cages were placed in an air conditioned room under controlled lighting conditions.

Diet
Pelleted standard Kliba 3433, batch no 40/99 diet supplied by Provimi Klima AG, CH-4303 Kaiseraugst, and water, were available ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

The test article was suspended in vehicle (polyethylene glycol PEG 300) at a concentration of 0.2g/ml and administered at a volume of 10ml/kg.

No. of animals per sex per dose:

3 males and 3 females

Control animals:

no

Details on study design:

Sample Preparation
The test article was suspended in vehicle (polyethylene glycol PEG 300) at a concentration of 0.2g/ml and administered at a volume of 10ml/kg.

Method
The animals received a single dose of the test article on a mg/kg body weight basis by oral gavage following fasting for approximately 16.5 hours, but with free access to water. Food was provided again approximately 3 hours after dosing.

The animals were examined for clinical signs four times during test day 1 and once daily during test days 2-15. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically.

Observations
No deaths occurred during the study. No clinical signs were noted during the observation period. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred in the main study during the respective fourteen day observation periods.

Clinical signs:

No overt signs of toxicity were observed in the main study during the respective fourteen day observation periods.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

The median lethal dose of Chlorocyclododecanone after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated as no death occurred therefore:
The fourteen day acute median lethal dose (LD50) of Chlorocyclododecanone in the rat is likely to be in excess of 2000 mg/kg bodyweight.

Executive summary:

An acute oral toxicity test carried out on two groups of three young adult rats (three males and three females) at a concentration of 0.2g/ml and administered at a volume of 10ml/kg. No deaths and no overt signs of toxicity were observed in the main study during their respective fourteen day observation periods. The fourteen day acute median lethal dose (LD50) of Chlorocyclododecanone in the rat is greater than 2000 mg/kg bodyweight.