4-hydroxy-2,2,6,6-tetramethylpiperidine-1-ethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Remarks:

Short-term Toxicology CIBA-GEIGY Limited

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-hydroxy-2,2,6,6-tetramethylpiperidine-1-ethanol

EC Number:

258-132-1

EC Name:

4-hydroxy-2,2,6,6-tetramethylpiperidine-1-ethanol

Cas Number:

52722-86-8

Molecular formula:

C11H23NO2

IUPAC Name:

1-(2-hydroxyethyl)-2,2,6,6-tetramethylpiperidin-4-ol

Details on test material:

- Physical state: solid; white
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

other: Tif:RAI f1

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Age at study initiation: young adult
- Weight at study initiation: 178 to 202 g
- Fasting period before study: overnight
- Housing: 5 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: Because of precipitation of the test article in the indicated vehicle, carboxymethylcellulose in aqueous polysorbate had to be used instead of distilled water.

MAXIMUM DOSE VOLUME APPLIED: 10ml/kg

Doses:

2000mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily for 14 days; weighing: immediately before administration and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

none

Clinical signs:

other: Piloerection, hunched posture, and dyspnea were seen. Additionally, reduced locomotor activity and ataxia was observed in all animals during the administration day. The males experienced tremor at the same time. The animals recovered within 6 days.

Gross pathology:

At necropsy, no deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Upon an acute oral administration and a 14 day post-treatment observation period, an LD50 value in rats of greater than 2000 mg/kg body weight was established.