2,2,6,6-tetramethyl-4-piperidone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study according to guideline

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 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2,6,6-tetramethyl-4-piperidone

EC Number:

212-554-2

EC Name:

2,2,6,6-tetramethyl-4-piperidone

Cas Number:

826-36-8

Molecular formula:

C9H17NO

IUPAC Name:

2,2,6,6-tetramethylpiperidin-4-one

Details on test material:

- Physical state: melt, yellow to dark yellow

- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

other: Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ciba-Geigy Limited, Animal Production, Switzerland
- Age at study initiation: Young adult animals
- Weight at study initiation: 220 - 246 g
- Housing: individually
- Diet: Rat diet (NAFAG 890 Tox, NAFAG, Switzerland); ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days before exposure


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 45 - 65
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: distilled water

Details on dermal exposure:

TEST SITE
- Type of wrap if used: The test article was covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: after 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml / kg bw (The test article was evenly dispersed on the skin.)
- Constant volume or concentration used: yes

Duration of exposure:

24 h

Doses:

2000 mg/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:
Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days;
Signs and symptoms: daily for 14 days
Body weight: immediately before application and on days 7 and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortalities occurred in this study.

Clinical signs:

other: Piloerection was seen, being a common symptom in acute dermal tests. At the application site, erythema was observed on day 1 after administration to day 3 in the males, day 2 in the females. The animals recovered within 3 to 4 days.

Gross pathology:

At autopsy, no deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information

Conclusions:

Under cconditions tested, the test substance did not show any death relating to dermal systemic effects. At the application site, erythema was observed on day 1 after administration to day 3 in the males, day 2 in the females. The animals recovered within 3 to 4 days.