N-butyl-2,2,6,6-tetramethylpiperidin-4-amine

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: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

RTC, Rome, Italy

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-butyl-2,2,6,6-tetramethylpiperidin-4-amine

EC Number:

252-899-6

EC Name:

N-butyl-2,2,6,6-tetramethylpiperidin-4-amine

Cas Number:

36177-92-1

Molecular formula:

C13H28N2

IUPAC Name:

N-butyl-2,2,6,6-tetramethylpiperidin-4-amine

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): N-Butyl-2,2,6,6-tetramethyl-4-piperidinamine (N-Butyl-TAD)
- Substance type: colourless liquid
- Physical state: liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Italy, San Pietro al Natisone (UD), Italy
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 176-200 g
- Fasting period before study: overnight before dosing
- Housing: 3 animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days prior dosing


ENVIRONMENTAL CONDITIONS
according to guideline

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 and 30 mg/mL
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: soluble in water

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

2000 and 300 mg/kg bw.

No. of animals per sex per dose:

3 (300 mg/kg bw was dosed in two steps with 3 animals each)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality/morbidity: twice daily; observations: 30 min, 1 (except step 2 and 3), 2 and 4 h post application and daily thereafter; weighing immediately prior dosing, days 2, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

approximate LD50

Effect level:

500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 cut-off

Mortality:

2000 mg/kg bw: all animals died within 4 hours post application
300 mg/kg bw: no mortality in two groups of 3 females each

Clinical signs:

other: Reduced activity, hunched posture, lethargy semi to full closed eyes, piloerection, salivation and mucus in the litter tray, recovery occurred by day 2 at 300 mg/kg bw.

Gross pathology:

no abnormalities were observed in any animal at the necropsy examination

Any other information on results incl. tables

According to Annex 2d of OECD TG 423 an LD50 cut-off of 500 mg/kg bw could be derived.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

Under conditions tested, all animals died on the day of dosing at a dose level of 2000 mg/kg bw. At a dose level of 300 mg/kg bw, no mortality was observed. Main clinical findings were reduced activity, hunched posture, lethargy semi to full closed eyes, piloerection, salivation and mucus in the litter tray, recovery occurred by day 2 at 300 mg/kg bw.