2,2,6,6-tetramethyl-4-piperidone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study was performed according to OECD guideline but prior to GLP requirements, but follows principles thereof. Study was selected as key study because the dose range was tested in a closer range than the supporting study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

GLP not implemented at that time.

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2,6,6-tetramethyl-4-piperidone

EC Number:

212-554-2

EC Name:

2,2,6,6-tetramethyl-4-piperidone

Cas Number:

826-36-8

Molecular formula:

C9H17NO

IUPAC Name:

2,2,6,6-tetramethylpiperidin-4-one

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Weight at study initiation: males 115 g, females 106 g
- Housing: 1-5 animals per cage (Makrolon type III)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4-8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 1°C
- Humidity (%): 60% +/- 5%
- Air changes (per hr): 15/h
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 21.10.1985 To: 05.11.1985

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

DOSE VOLUMES APPLIED: 1.08-1.706 mg/kg

Doses:

1000, 1250, 1580 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation up to 6 hours after application and daily thereafter, weighing before application and 1, 7 and 14 days thereafter
- Necropsy of survivors performed: yes

Statistics:

LD50 value was determined according to Litchfield and Wilcoxon (J. Pharmacol. Exp. Ther. 96, 1949, 99).

Results and discussion

Preliminary study:

A preliminary study for dose finding purposes was performed but not reported.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 330 mg/kg bw

Mortality:

Mortality was seen in all dose groups:
1000 mg/kg bw: 0/5 males, 1/5 females (within 3.5 h)
1250 mg/kg bw: 1/5 males, 4/5 females (within 24 h)
1580 mg/kg bw: 4/5 males, 3/5 females (within 120 h)

Clinical signs:

other: Piloerection, tremors and dizziness occured approx. 30 min after application. Slight sedation, ataxia, impaired respiration, hypothermia, temporarily abdominal posture, convulsions and halfclosed or closed eyes were observed. Animals dosed with 1000 and 1

Gross pathology:

Post mortem hyperemia of gastric and intestinal mucosa, extended liver and spleen were observed. One animal showed a decoloured kidney and pancreas.
Some of the necropsied animals showed hyperemia of gastric and intestinal mucosa und dark spots on the kidneys.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

Under the conditions of the study an acute oral LD50 of 1330 mg/kg bw in rats was found.