N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 Dec 1984 - 22 Jan 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions

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)

Version / remarks:

adopted May 12, 1981

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine

EC Number:

262-679-1

EC Name:

N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine

Cas Number:

61260-55-7

Molecular formula:

C24H50N4

IUPAC Name:

N1,N6-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, D-4799 Borchen
- Weight at study initiation: males: 172 g; females: 130 g
- Fasting period before study: 16 hours
- Housing: 1-5 animals in type III Makrolon
- Diet (ad libitum): R10 complete feed for rats, Ssniff Spezialfutter GmbH, D-4770 Soest
- Water (ad libitum): tap water
- Acclimation period: 4-8 days

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

maize oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 cm³/kg bw

DOSAGE PREPARATION: The product was dissolved in maize germ oil at approximately 60 °C and administered at 40 °C.

Doses:

501, 631, 794, 1000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before the treatment and 1, 7, 14 days after the treatment
- Necropsy of survivors performed: yes: All of the animals sacrificed at the end of the investigation and animals which died during the study period were dissected and macroscopically examined, and the findings were recorded.
- Other examinations performed: clinical signs: Up to six hours after the treatment and then daily, the onset, type and duration of all signs of toxicity and the time of death were noted.

Statistics:

The means (x) of the bodyweights were calculated. The LD50 is generally determined as described by Litchfield and Wilcoxon and reported with 95% confidence limits (J. Pharmacol. Exp. Ther. 96, 1949, 99).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

820 mg/kg bw

Based on:

test mat.

95% CL:

703 - 956

Mortality:

see Tab.1 (Any other information on results incl. tables)

Clinical signs:

other: Symptoms which occurred from approximately 30 minutes after administration were ruffled fur, in some case prone position, staggering, twitching, mild to strong sedation and ataxia, dark eyes and tremor and later crouched posture, hypothermia and, at the h

Gross pathology:

In the post-mortem dissections, hyperaemia of the gastric mucosa and small intestine mucosa, stasis of the liver and dark-coloured liver were observed. Dissection at the end of the test revealed in some animals hyperaemia of the gastric mucosa and small intestine mucosa, spots on both kidneys in 2 animals and in 2 animals only on the right kidney.

Any other information on results incl. tables

Tab.1 Acute oral toxicity (LD50) for rats

Dose mg/kg	Sex	Toxicological result	Death occurred within (h)	LD50 mg/kg
501	male	0/5/5 *
	female	0/5/5	-
631	male	2/5/5
	female	0/5/5	4
794	male	4/5/5		820 (703-956) slope function S = 1.36
	female	2/5/5	24
1000	male	3/5/5
	female	3/5/5	24

*number of animals which died/number of animals with signs/number of animals used

 

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

In the determination of the acute oral toxicity on male and female rats it was found that the LD50 of the test substance is 820 mg/kg bw. Under the experimental conditions described, the test substance fulfils the GHS criteria for classification into the acute toxicity Category IV.