Registration Dossier

Administrative data

Description of key information

The oral toxicity study with 2 test groups of each 3 female rats administered with 2000 mg/kg bw of the test substance showed no mortality, clinical signs and pathological findings. The median lethal dose of rats after oral administration therefore is above 2000 mg/kg bw.   The study on dermal toxicity in rats with a dose of 2000 mg/kg bw of the test substance revealed an LD50 of above 2000 mg/kg bw. In both male and female rats different stages of erythema, edema, scaling and incrustations were observed but disappeared before day 10 after application of the test substance.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 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:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

Acute Toxic Class method (Bioassay 2015)

In an acute oral toxicity study performed according to OECD guideline 401, 2000 mg/kg of the undiluted test item were administered by gavage to two test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females).

2000 mg/kg (first and second test group):

- No mortality occurred.

- No clinical signs were observed in the animals.            

- The mean body weight of the surviving animals increased within the normal range throughout the study period with three exceptions (one in the first test group and two in the second test group). In three females body weights increased within the normal range during the first week, but the animals revealed a stagnation of body weight during the second week. This effect is observed occasionally 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 surviving animals sacrificed at the end of the observation period.

The acute oral LD50 was determined to be above 2000 mg/kg bw.

Acute dermal toxicity study (Bioassay 2015)

In an acute dermal toxicity study (Limit Test) according to OECD guideline 402, young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the undiluted test item to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10 % of the total body surface area. 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 the first 10 days after administration:

- Very slight to moderate erythema (grade 1 to 3)

- Very slight to moderate edema (grade 1 to 3)

- Incrustations

- Scaling

- The mean body weight of the male animals increased within the normal range throughout the study period. The body weight of the female animals increased within the normal range throughout the study period with one exception. One animal lost weight during the first week, probably due to the bandage procedure, but body weights were within the normal range during the second week.

- 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 above 2000 mg/kg bw.

Justification for classification or non-classification

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. No mortality occurred at the limit dose of 2000 mg/kg bw. As a result the substance does not need to be classified and labelled for acute toxicity (oral, dermal) under Regulation (EC) No 1272/2008.