Registration Dossier
Registration Dossier
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EC number: 287-466-0 | CAS number: 85508-41-4
Endpoint summary
Administrative data
Description of key information
LD50 > 2000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
An acute oral toxicity study with Disperse Blue 291:1 was conducted in female rats according to OECD 423 at the limit dose levels of 2000 mg/kg body weight.
No lethality occurred after application of 2000 mg/kg body weight. Besides unspecific clinical signs the animals showed impairments of motility and respiration starting 30 – 60 minutes after test substance administration on Day 1. Additionally, urine was discoloured reddish on Day 1 and further on, urine and faeces were discoloured dark up to Day 3. From day 4 until the end of the study, no clinical signs were observed. One animal showed a slight body weight reduction in the second week of the study. Development of body weight was not impaired in the other animals. All animals were killed at the end of the observation period and underwent necropsy. No macroscopically visible changes were observed during necropsy.
A study was conducted with a structural analogue to determine the acute inhalation toxicity of the test substance according to an internal procedure. A group of 12 rats were exposed for 8 h to the vapour of saturated test substance and thereafter observed for 14 days. Under the study conditions, no mortality was observed in the treated rats.
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008), 3.1 Acute toxicity section, substances can be allocated to one offour toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).
The oral LD50 value was established to be more than 2000 mg/kg body weight, therefore the test substance is out of any classification limit for acute oral toxicity (oral acute toxicity Category 4: 300 < ATE ≤ 2000 mg/kg bw).
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