Registration Dossier
Registration Dossier
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EC number: 225-555-8 | CAS number: 4926-55-0
Endpoint summary
Administrative data
Description of key information
According to the results of the key study (Burnett, 1987, Klimisch 2), the Lethal Dose 50 (LD50) value of the test item HC Yellow No. 2 was defined between 625 mg/kg and 1250 mg/kg bw through oral gavage route. Hence, according to the CLP criteria, the test item was classified as Acute Oral Hazard Category 4.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 250 mg/kg bw
Additional information
One key study was available in order to assess the acute toxicity of the test item HC Yellow No.2 :
-Burnett, 1987, Klimisch 2 : A 10% suspension of the test substance in 3% acacia was administered once via oral gavage to groups of 5 male and 5 female rats at the dose levels 625, 1250, and 2500 mg/kg bw. At the low dose no mortalities were observed, at the mid dose no deaths were seen in the males while 3 of 5 females died within 8 h after dosing. At the high dose all animals died. The LD50 value was defined between 625 mg/kg bw and 1250 mg/kg bw according to mortality observed in females.
Justification for classification or non-classification
According to the results of the key study (Burnett, 1987, Klimisch 2), the Lethal Dose 50 (LD50) value of the test item HC Yellow No. 2 was defined between 625 mg/kg and 1250 mg/kg bw through oral gavage route. Hence, according to the CLP criteria, the test item was classified as Acute Oral Hazard Category 4.
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