1-acetyl-4-(3-dodecyl-2,5-dioxo-1-pyrrolidinyl)-2,2,6,6-tetramethylpiperidine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD 401 (1981)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-acetyl-4-(3-dodecyl-2,5-dioxo-1-pyrrolidinyl)-2,2,6,6-tetramethylpiperidine

EC Number:

411-930-5

EC Name:

1-acetyl-4-(3-dodecyl-2,5-dioxo-1-pyrrolidinyl)-2,2,6,6-tetramethylpiperidine

Cas Number:

106917-31-1

Molecular formula:

C27H48N2O3

IUPAC Name:

1-(1-acetyl-2,2,6,6-tetramethylpiperidin-4-yl)-3-dodecylpyrrolidine-2,5-dione

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Bor: WISW

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, Borchen
- Females (if applicable) nulliparous and non-pregnant: yes
- Weight at study initiation: 127 g
- Fasting period before study: 16 h
- Housing: 1-5 animals in Type II Makrolon cage
- Diet (e.g. ad libitum): R10 complete feed for rats, Ssniff Spezialfutter GmbH, Soest; ad libitum
- Water (e.g. ad libitum): Tap water; ad libitum
- Acclimation period: 4-8 days

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

IN-LIFE DATES:
From: 13.5. To: 27.5.1988

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

3000 mg/kg

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing:
signs: up to 6 h after tretement and then daily
weighing: before treatment, 1, 7 and 14 days after treatment
- Necropsy of survivors performed: yes

Statistics:

LD50 determined according to Litchfield and Wilcoxon

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 3000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 3000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: other: Signs of toxicity related to dose levels: No signs of toxicity were noted.

Gross pathology:

Dissection at the end of the experiment revealed no evidence of macroscopically detectable organ changes.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of this substance was determined to be greater than 3000 mg/kg body weight.

Executive summary:

In a determination of the acute oral toxicity on male and female rats it was found that the LD50 of the substance is greater than 3000 mg/kg of body weight. The treated animals were free of signs of toxicity. There was no influence on the increase in body weight. Dissection at the end of the experiment revealed no evidence of macroscopically detectable organ damages.