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Description of key information

Repeated dose toxicity (90 d, feeding)

A feeding study was carried out according to OECD Guideline 409 on Wistar rats (l0 anirnals/sex/group over a test period of 90 days. The appropriate dose levels were determined in 14 -d range finding study. The dose levels in the main study were 0, 0.0085, 0.0847 and 0.8469 g/kg f'eed, equal to cornpound intake of 0, 0.57, 5.66 and 56.06 mg/kg/d for males and 0, 0.64, 6.24 and 64.98 mg/kg/d for females. There was no mortality observed during the study. Clinical signs included symptoms of depression, reduction in activity and reduced food consumption were observed in mid sand high dose groups. Body weights, food consumption and food efficiency were statistically decreased in mid and high dose groups mainly in both sexes starting from week 3 of the dosing period. A number of changes were noted in blood parameters of the mid and high dose animals. These findings included decrease in blood cell counts, increase in hemtocrit values, decrease in lymphocytes, decrease of creatinine concentrations etc. Changes on kidney-to-body-weight ratios and brain-to-body-weight ratios were seen in mid and/or high dose groups on females. Histopathological examination showed a number of effects in some animals of mid and high dose groups, such as large number of inflammatory cells in rat epididymis.

Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) was 0.57 mg/kg/d for males and 0.64 mg/kg/d for females.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
0.57 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Guideline study; Klimisch 2 (non GLP)
System:
other: effects were seen in a number of different parameters
Organ:
not specified

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the results of the study, the test item needs to be classified as follows:

Acute toxicity cat.3; oral - H 301: Toxic if swallowed

Acute toxicity cat.2; dermal - H 310: Fatal in contact with skin