Registration Dossier
Registration Dossier
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EC number: 279-242-6 | CAS number: 79720-19-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- 3-dodecyl-1-(2,2,6,6-tetramethyl-4-piperidyl)pyrrolidine-2,5-dione
- EC Number:
- 279-242-6
- EC Name:
- 3-dodecyl-1-(2,2,6,6-tetramethyl-4-piperidyl)pyrrolidine-2,5-dione
- Cas Number:
- 79720-19-7
- Molecular formula:
- C25H46N2O2
- IUPAC Name:
- 3-dodecyl-1-(2,2,6,6-tetramethylpiperidin-4-yl)pyrrolidine-2,5-dione
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Bor: WISW (SPF TNO)
- 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
- Age at study initiation: males - 123 g; females - 105 g
- Fasting period before study: 16 h
- Housing: in groups of 1 to 5 in makrolon type III cages
- Diet (e.g. ad libitum): R10 Alleindiät für Ratten, 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: 30.07. To: 16.08.1984
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The product was administered undiluted. Rats which had been fasted for 16 hours received a single oral dose by gavage (volume: 1.65 - 2.62 ml/kg).
- Doses:
- 3 doses: 1580 mg/kg, 1990 mg/kg and 2510 mg/kg
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- no
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1 724 - 2 320
- Mortality:
- dose group 1580 mg/kg: male: 0 animals; female 1 animal (death occurred: 48 h)
dose group 1990 mg/kg: male: 2 animals; female 2 animals (death occurred: 10 days)
dose group 2510 mg/kg: male: 4 animals; female 5 animals (death occurred: 8 days) - Clinical signs:
- other: The signs which appeared about 1 h after administration were ruffled fur, diarrhoea, sedation, ataxia, walking on tiptoe, bleeding from the nose, squatting, impairment of movement, tremor, hypothermia, and contraction of the eyes which were dark red. Ruff
- Gross pathology:
- On post mortem dissection, hyperemia of the gastrointestinal mucosa was found in 4 animals. The gastric mucosa was white in one animal, and the small intestine was very pale in another. In addition, some animals showed pale spots on the liver. The dissection after the end of the investigation showed a pale coloration of the intestinal mucosa, swelling of the gastrointestinal tract and adhesions of abdominal organs with the peritoneum and the diaphragm. In one animal the kidneys also had dark spots.
Any other information on results incl. tables
Observations:
Body weights: The animals were weighed before treatment and 1, 7 and 14 days after treatment.
Signs: The onset, type and duration of all signs of toxicity, and the time of death, were noted up to 6 hours after treatment, and then daily.
Autopsy: All the animals sacrificed at the end of the investigation for each dose were dissected and subjected to gross examination, and the findings were recorded.
Evaluation: The mean body weights were calculated. In general, the LD50 is determined by the method of Litchfield and Wilcoxon, and reported with 95 % confidence limits.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- From the acute oral toxicity study, a LD50 of 2000 mg/kg was obtained.
- Executive summary:
From the acute oral toxicity study, a LD50 of 2000 mg/kg was obtained.
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