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

Endpoint summary

Description of key information

A single dose of the test item was administered orally or dermally to Wistar rats at concentrations of 2000 mg/kg bw.

No mortality occurred. Clinical examiniation and gross necropsy did not reveal any findings. The LD50 after oral and dermal administration is therefore considered to be > 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

300 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

In an acute dermal toxicity study, young adult Wistar rats were dermally exposed to a single dose of 2000 mg/kg bw to the clipped skin and covered by semi-occlusive dressing for 24 hours. The animals were observed for 14 days. No mortality occurred. No signs of systemic toxicity were observed. The following test item-related local effects were recorded during the course of the study, local effects occurred within 14 days after administration: slight to severe erythema grade (1 to 4), very slight to moderate edema (grade 1 to 3), incrustations, scaling. Additionally the local clinical signs were noted beyond the application site. The body weight of the female animals stagnated in three animals and marginally decreased in two other animals during the first observation week, but increased within the normal range during the second week. The mean body weight of the male animals increased within the normal range throughout the study period. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 2000 mg/kg bw.

In an acute oral toxicity study doses of 2000 and 300 mg/kg bw of the test item were administered by gavage to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 3 females and 300 mg/kg bw in 6 females). The following test substance-related clinical observations were recorded, clinical signs occurred within the first 6 days after administration:

2000 mg/kg (first test group):

All animals were sacrificed in a moribund state (study day 3 or 6). Impaired and poor general state, dyspnoea piloerection, exsiccosis, body weight loss, chromodacryorrhea and staggering in all animals. Macroscopic pathological findings in the three animals sacrificed moribund were spotted, light discoloration of the liver in all animals, yellowish discoloration of the appendix contents in one animal and red discoloration of the glandular stomach in two animals.

300 mg/kg (both test groups):

Impaired general state and piloerection in one animal each.

The acute oral LD50 was calculated to be LD50, oral, rat > 300

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is considered to be classified for acute oral toxicity under Directive 67/548/EEC.

                               

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified for acute oral toxicity under Regulation (EC) No. 1272/2008.