3-dodecyl-1-(2,2,6,6-tetramethyl-4-piperidyl)pyrrolidine-2,5-dione

Endpoint summary

Description of key information

An oral LD50 of 2000 mg/kg bw has been determined after single oral application.

Due to the corrosive properties of the substance no tests on acute toxicity after dermal or inhalation exposure have been performed.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

reliable with minor restrictions

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as corrosive to the skin

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as corrosive to the skin

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute toxicity after single oral application was tested in groups of 5 male and 5 female rats, which received single doses of 1580, 1990 or 2510 mg/kg bw. 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. Ruffled fur persisted to the end of the investigation. The treatment had a transient inhibitory effect on the body weight gain.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. Based on the observed mortality the LD₅₀value for acute oral toxicity was derived at 2000 mg/kg bw.

Due to the corrosive properties of the substance no tests on acute toxicity after dermal or inhalation exposure have been performed.

Justification for classification or non-classification

 Based on the results of the acute oral toxicity study, which revealed an LD₅₀(oral) value of 2000 mg/kg bw the substance has to be classified as acutely toxic Cat. 4.