N,N'-dibutyl-N,N'-bis(1,2,2,6,6-pentamethylpiperidin-4-yl)-6-(pyrrolidin-1-yl)-1,3,5-triazine-2,4-diamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-dibutyl-N,N'-bis(1,2,2,6,6-pentamethylpiperidin-4-yl)-6-(pyrrolidin-1-yl)-1,3,5-triazine-2,4-diamine

EC Number:

940-393-4

Cas Number:

1702355-94-9

Molecular formula:

C35 H66 N8

IUPAC Name:

N,N'-dibutyl-N,N'-bis(1,2,2,6,6-pentamethylpiperidin-4-yl)-6-(pyrrolidin-1-yl)-1,3,5-triazine-2,4-diamine

Test material form:

solid: bulk

Details on test material:

- State of aggregation: solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: 10 weeks
- Fasting period before study: 16h before administration
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 6 and 40 g/ 100 ml, respectively
- Amount of vehicle (if gavage): 5 ml/ kg bw
- Justification for choice of vehicle: good homogeneity

MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg bw

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several times on the day of administration and at least once during each workday thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Mortality:

One animal was sacrificed in a moribund state on study day 3, while the two animals were sacrificed in a moribund state on study day 6. No mortality occurred in both 300 mg/kg bw test groups.

Clinical signs:

In all animals of the 2000 mg/kg bw test group impaired general state was noted from hour 2 or 3 until hour 5 and was noted again in two animals on study day 3. Poor general state was noted in all animals on study day 3 or 6, respectively.
Piloerection was observed in all animals from hour 2 or 3 until hour 5 and was noted in one animal on study day 3 again while two animals showed this finding from study day 3 until study day 6. Dyspnoea and exsiccosis were noted on study day 3 in all animals and persisted in two of these animals up to study day 6. Staggering, loss of body weight and chromodacryorrhea were observed in all animals on study day 3 or 6, respectively. Reduced defecation was observed in two animals from study day 3 until study day 6, while diarrhea and feces smeared fur were noticed in these animals on study day 6. On the same day one of these animals showed yellowish discoloration of feces. On study day 3 one animal showed urine smeared fur and lack of defecation.
In the first 300 mg/kg bw test group one animal showed impaired general state, piloerection and chromodacryorrhea on study day 1 after administration. In the second 300 mg/kg bw test group one animal showed impaired general state and piloerection on study day 2.

Body weight:

The mean body weight of the surviving animals increased within the normal range throughout the study period with one exception in the second 300mg/kg test group. This animal revealed a stagnation of body weight in the second week.

Gross pathology:

In the 2000 mg/kg bw test group the following macroscopic pathologic findings were observed in the animals sacrificed in a moribund state: spotted, light discolored liver in all animals, red discoloration of the glandular stomach in two animals and yellowish discoloration of the appendix content in one animal. There were no macroscopic pathological findings in the surviving animals sacrificed at the end of the observation period (300 mg/kg bw: 6 females).

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria