1,3,5-Triazine-2,4,6-triamine, N2,N2'-1,6-hexanediylbis[N4,N6-dibutyl-N2,N4,N6-tris(2,2,6,6-tetramethyl-4-piperidinyl)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 24, 2014 - November 05, 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nosan No. 8147 as this in line with OECD 423.

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N2-[6-({4,6-bis[butyl(2,2,6,6-tetramethylpiperidin-4-yl)amino]-1,3,5-triazin-2-yl}(2,2,6,6-tetramethylpiperidin-4-yl)amino)hexyl]-N4,N6-dibutyl-N2,N4,N6-tris(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4,6-triamine

EC Number:

629-754-4

Cas Number:

210988-99-1

Molecular formula:

C82 H156 N18

IUPAC Name:

N2-[6-({4,6-bis[butyl(2,2,6,6-tetramethylpiperidin-4-yl)amino]-1,3,5-triazin-2-yl}(2,2,6,6-tetramethylpiperidin-4-yl)amino)hexyl]-N4,N6-dibutyl-N2,N4,N6-tris(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4,6-triamine

Details on test material:

- Physical state: Solid / white to beige
- Storage condition of test material: Room temperature

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: approx. 10 weeks
- Weight at study initiation: average weight: 174.8g
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: Single housing in Makrolon cage, type III
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water: Tap water ad libitum
- Acclimation period: at least 5 days

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Remarks:

Corn oil Ph.Eur

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 40g/100ml
- Amount of vehicle (if gavage): 5ml/kg bw
- Justification for choice of vehicle: Good homogeneity in corn oil Ph.Eur.

DOSAGE PREPARATION (if unusual):
The test item preparation was produced for each administration group shortly before administration by stirring with a high speed homogenizer (Ultra-Turrax) and a magnetic stirrer. Additionally, the homogeneity of the test item preparation during administration was ensured by stirring with a magnetic stirrer.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

2000 mg/kg

No. of animals per sex per dose:

6 (2 groups of three females each)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Clinical observations: Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter.
- Mortality: A check for any dead or moribund animals was made at least once each workday; these records are archived by Bioassay.
- Pathology: Necropsy with gross-pathology examination was performed on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with gradually increasing concentrations.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred in both 2000 mg/kg bw test groups

Clinical signs:

other: All animals of the first 2000 mg/kg bw test group showed impaired general state and piloerection from hour 2 until hour 5 after administration. In the animals of the second 2000 mg/kg bw test group impaired general state and piloerection were noticed in t

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period (6 females).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study the median lethal dose of the test article after oral administration was found to be greater than 2000 mg/kg bw in rats.

Executive summary:

In a GLP-compliant acute oral toxicity study performed according to the Acute Toxic Class method (OECD 423), a dose of 2000 mg/kg bw of the test item (preparation in corn oil Ph.Eur.) was administered by gavage to two test groups of three fasted female Wistar rats each. No mortalities occurred. Impaired general state and piloerection in all animals occurred within the first 3 days after administration. The body weight of the animals in both test groups increased within the normal range throughout the study period with two exceptions in the first test group. In these two animals the body weights were within the normal range during the first week, but stagnated during the second week. This effect is observed at times in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth. There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period (6 females). The acute oral LD50 was calculated to be > 2000 mg/kg bw.