Registration Dossier
Registration Dossier
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EC number: 211-317-0 | CAS number: 638-07-3
Endpoint summary
Administrative data
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
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