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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

Identification: TKA 40270 (CGPS 345)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals: Rat, HanRcc: WIST(SPF)
Rationale: Recognized by international guidelines as a
recommended test system.
Source: RCC Ltd
Laboratory Animal Services
Wölferstrasse 4
4414 Füllinsdorf / Switzerland
Number of Animals per Group: 5 males 5 females
Total number of Animals: 10
Age when treated: Males: 8 weeks
Females: 11 weeks
Identification: Unique cage number and corresponding color-coded
spots on the tail. The animals were marked at
acclimatization start.
Randomization: Selected by hand at time of delivery.
No computer generated randomization program.
Acclimatization: 7 days under laboratory conditions, after health
examination. Only animals without any visible signs
of illness were used for the study.

Conditions: Standard Laboratory Conditions. Air-conditioned
with 10-15 air changes per hour, and continuously
monitored environment with ranges for room
temperature 22 ± 3 °C and for relative humidity
between 30-70 % (values above 70 % during
cleaning process possible), automatically controlled
light cycle of 12 hours light and 12 hours dark,
music during the daytime light period.
Accommodation: During acclimatization in groups of five per sex in
Makrolon type-4 cages with standard softwood
bedding. Individually in Makrolon type-3 cages with
standard softwood bedding during treatment and
observation.

Diet: Pelleted standard Provimi Kliba 3433 rat/mouse
maintenance diet, batch no. 41/07 (Provimi Kliba
AG, CH-4303 Kaiseraugst/Switzerland) ad libitum.
Results of analyses for contaminants are archived at
RCC Ltd.
Water: Community tap water from Füllinsdorf ad libitum.
Results of bacteriological, chemical and contaminant
analyses are archived at RCC Ltd.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: The bracks of the animals
- % coverage: Semi-occlusive
- Type of wrap if used: An elastic adhesive bandage.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lukewarm tap water and dried with disposable paper towels
- Time after start of exposure: 1 day

Duration of exposure:

24 hours

Doses:

2000 mg/kg by dermal application

No. of animals per sex per dose:

Male: Five
Female: Five

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on test days 1, 8 and 15
- Necropsy of survivors performed: yes
-Viability / Mortality: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5
hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15.
-Clinical Signs: Daily during the acclimatization period, during the
first 30 minutes and at approximately 1, 2, 3 and 5
hours after administration on test day 1. Once daily
during days 2-15. All abnormalities were recorded.
-Local Signs Once daily during days 2-15. All abnormalities were recorded

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths occurred during the study

Clinical signs:

other: No clinical signs were observed during the course of the study.

Gross pathology:

Necropsy:
All animals were killed at the end of the observation period by carbon dioxide asphyxiation and
discarded after macroscopic examinations were performed. No organs or tissues were retained.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median lethal dose (LD50) of the test item after single dermal administration to rats of
both sexes, observed over a period of 14 days is greater than 2000 mg/kg body weight