2,2,6,6-tetramethyl-4-piperidylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: study was performed prior to OECD guideline and GLP but follows principles thereof.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

GLP compliance:

no

Remarks:

no GLP 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-piperidylamine

EC Number:

253-197-2

EC Name:

2,2,6,6-tetramethyl-4-piperidylamine

Cas Number:

36768-62-4

Molecular formula:

C9H20N2

IUPAC Name:

2,2,6,6-tetramethylpiperidin-4-amine

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: W. Gassner, Sulzfeld, Germany
- Weight at study initiation: males: 160-210 g, females 125-170 g
- Fasting period before study: 16 hours
- Housing: 5 per cage
- Diet:. ad libitum
- Water: ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: constantly 10 ml/kg bw

Doses:

1; 1.21; 1.47; 1.78 ml/kg bw (corresponding to 893, 1080, 1310, 1590 mg/kg bw)

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
body weight: once day of application, day 7 and day 15,
clinical signs: on application day several times, thereafter once daily.
- Necropsy of survivors performed: yes

Statistics:

Probit analysis according to FINNEY

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 000 mg/kg bw

95% CL:

820 - 1 089

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1.106 mL/kg bw

95% CL:

0.92 - 1.22

Mortality:

control: no mortality ocurred
Dose group 1: 3 of 5 females died on days 3-7
Dose group 2: one male and three females died within 6-24 hours after exposure, further one male and two females died on day 2 after application
Dose group 3: one male and three females died within 6-24 hours after exposure, further two females died on day 2 after application, three males died on day 3-7 after application.
Dose group 4: 4 males and 5 females died within 6-24 hours after exposure, further one male died on day 2 after application.

Clinical signs:

other: Clinically non-characteristic signs of extreme discomfort and suffering (like piloerection, decrease of motility, paleness of extremities)

Gross pathology:

congestion of spleen and liver, corrosions in the gastro-intestinal tract, destruction of the intestinal mucosa.

Other findings:

Findings are consistent with tissue colliquations caused by strongly alkaline substances.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

Under present conditions, a single adminitration of the test item revealed a LD50 of 1000 mg/kg bw (95-% confidence range: 830 - 1100 mg/kg.)
Clinically non-characteristic signs of extreme discomfort and suffering. Macroscopic pathological findings were congestion of spleen and liver, corrosions in the gastro-intestinal tract, destruction of the intestinal mucosa.
Findings are consistent with tissue colliquations caused by strongly alkaline substances.