4-Piperidinone, 2,6-diethyl-2,3,6-trimethyl-1-(1-phenylethoxy)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Performed according to OECD and EEC-guidelines under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

ldentity: TKA 40270
Product name: CGPS 345

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test system: Rat, HanBrl: Wist (SPF)
Rationale: Recognized by the international guidelines as a reoommended test system.
Source: RCC Ltd, Biotechnotogy and Animal Breeding Division CH-4414 Füllinsdorf / Switzerland
Number of animals per group: 3 males or 3 females
Total number of animals: 3 males, 3 female
Age when treated: Males: 8 weeks; Females: 10 week
Identification: Unique cage card and corresponding color-coded spots on the tail.
Acclimatization: Under laboratory conditions, after health examination. Only animals without any visible signs of uliness were used for the
study.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

The animals received a single dose of the test item by oral gavage administration at 2000 mg/kg body weight after being fasted for 16 to 20 hours
(access to water was permitted). Food was provided again approximately 3 hours after dosing.
The application volume was 10 ml/kg body weight.
Rationale: Oral administration was considered to be an appropriate application method as it is a possible route of human exposure during manufacture, handVng and use of the test item.

Doses:

2000 mg/kg body

No. of animals per sex per dose:

3 males
3 females

Control animals:

no

Details on study design:

Three male and three female HanBrl: WIST (SPF) rats were treated with TKA 40270 (CGPS 345) by oral gavage administration at a dosage of
2000 mg/kg body weight. The test item was diluted in vehicle (PEG 300) at a concentration of 0.2 g/ml and administered at a volume dosage
of 10 ml/kg.
The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were
examined for clinical signs at approximately 0 (2000 mg/kg treated females only), 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15, Mortality/viability was recorded twice daily during test days 1-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

Statistics:

No statistical analysis was used.

Results and discussion

Preliminary study:

No preliminary study

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality

Clinical signs:

other: No clinical signs

Gross pathology:

No macroscopic findings were recorded at necropsy.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU