Registration Dossier
Registration Dossier
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EC number: 200-796-1 | CAS number: 73-24-5
Endpoint summary
Administrative data
Description of key information
Available repeated dose oral toxicity data in rats were used to determine the LD50 of the test substance in accordance with REACH Annex XI, 1.1.2 (7.5.1 -1).
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 227 mg/kg bw
- Quality of whole database:
- Klimisch Code 2
Additional information
The subacute toxic effects (36 days) of the test item (0.05, 0.10, 0.20, 0.40 0.80 and 1.6% of the diet resembling 35, 70, 130, 196, 286, and 367 mg/kg bw/d) was investigated in young male SD rats (reference 7.5.1 -1). Animals consumed normal amounts of food and water at low test item levels (0.05-0.10%). Higher levels (>0.20%) significantly reduced food consumption and increased water intake. Evidence of gross pathology in soft tissues was absent at 0.05 to 0.10% dose group. Levels greater than 0.10% produced definite pathological changes in the kidney. The kidneys were greatly enlarged and its absolute weight increased more than 2x normal. The enlarged kidneys were granular, edematous, greyish, and soft. A significant change in blood urea nitrogen occurred when the level of the test item approached 0.20%. No significant changes were found in blood uric acid at all dietary levels. Low levels did not change the hematological indices with the exception of the leukocyte count. A significant leukocytosis occured at all levels (0.05-1.6%) of adenine. An increase in systolic blood pressure but no change in EKG was noted at levels >0.20% adenine. An oral LD50 of 227 mg/kg bw/d was determined. Based on the weight gain a LOAEL of 35 mg/kg bw/d was determined.
Justification for classification or non-classification
Classification, Labelling, and Packaging
Regulation (EC) No 1272/2008
The available experimental test data are suitable for classification
purposes under Regulation (EC) No 1272/2008 (CLP). As a result the test
item is considered to be classified for acute oral toxicity (UN GHS
Category 3, H301) under Regulation (EC) No 1272/2008, as amended
for the tenth time in Regulation (EU) No 2017/776.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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