2,2,6,6-tetramethylpiperidin-4-ol

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: Guideline study (OECD)

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1998

Reference 2

Reference Type:

secondary source

Title:

SIDS DOSSIER 2,2,6,6- Tetramethylpiperidin-4-oI, CAS-No: 2403-88-5

Author:

OECD SIDS

Year:

2002

Bibliographic source:

OECD SIDS

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Remarks:

Biosafety Research Center, Food, Drugs and Pesticides (An-Pyo Center), Japan

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2,6,6-tetramethylpiperidin-4-ol

EC Number:

219-291-2

EC Name:

2,2,6,6-tetramethylpiperidin-4-ol

Cas Number:

2403-88-5

Molecular formula:

C9H19NO

IUPAC Name:

2,2,6,6-tetramethylpiperidin-4-ol

Details on test material:

- Name of test material (as cited in study report): 2,2,6,6-Tetramethylpiperidin-4-ol
- Physical state: solid

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 7 weeks old
- Weight at study initiation: 177 - 195 g for males, 139 - 153 g for females

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

590, 769, 1000, 1300, 1690, 2197 mg/kg bw

No. of animals per sex per dose:

no data

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each rat was weighed immediatly prior to treatment, the day after and weekly thereafter for two-week post-treatment observation period. The rats were observed periodically.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Statistics:

Lichtfield-Wilcoxon method

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

1 564 mg/kg bw

95% CL:

1 326 - 1 842

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

1 482 mg/kg bw

95% CL:

1 239 - 1 774

Mortality:

Death of animals was observed at 1300 mg/kg and higher dose groups of the both sexes. No obvious sex difference was noted. At doses ≥ 1690 mg/kg, death occurred mostly on the day after dosing.

Clinical signs:

other: In all groups, clinical signs of decreased locomotor activity, mydriasis and blepharoptosis were observed in both sexes and were most pronounced at the highest dose applied (2197 mg/kg). Prone position, hypothermia and tremors were observed in 1300 mg/kg

Gross pathology:

Pathological examinations were conducted in rats which died prematurely. Pathological lesions due to 2,2,6,6-Tetramethylpiperidin-4-ol were observed in the stomach and duodenum of both sexes, consisting of haemorrhages, necrosis, and vacuolar degeneration (stomach and duodenum) and edema (duodenum).

Any other information on results incl. tables

Mortality of male and female rats dosed orally with the undiluted test material:

dose level (mg/kg)	#dead/#treated		Time of Death
	Males	Females	Males	Females
592	0/5	0/5	-	-
769	0/5	0/5	-	-
1000	0/5	0/5	-	-
1300	1/5	1/5	1 rat - day 13	1 rat - day 6
1690	4/5	3/5	3 rats - day 1	3 rats - day 1
			1 rat - day 7
2197	5/5	5/6	5 rats - day 1	5 rats - day 1