Registration Dossier
Registration Dossier
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EC number: 407-240-9 | CAS number: 159604-94-1 BLUE 10 25 964
Endpoint summary
Administrative data
Description of key information
LD50 (rat, m/f) > 5000 mg/kg bw (acute toxicity oral)
LD50 (rat, m/f) > 2000 mg/kg bw (acute toxicity dermal)
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 5 000 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
Additional information
Acute oral toxicity: The study was carried out in accordance with OECD Guideline No. 401, "Acute Oral Toxicity" and EEC Directive 84/449/EEC, Part B. 1, "Acute Toxicity-oral ". The test item was administered by oral gavage, to five rats of each sex, at 5000 mg/kg body weight. Macroscopic examination was performed at the end of the experimental period.
Three animals died within 24 hours of dosing.
Lethargy, piloerection and convulsions were noted among the animals on the day of treatment.
All animals showed body weight gain over the study period.
Macroscopic post mortem examination of the animals that died during the study revealed the stomach and intestine contents to be blue (test substance) . Macroscopic post mortem examination of the surviving animals at termination revealed the lungs of one male to be flecked grey/green and the urinary bladders of two males to contain white particles.
The oral LD50 value of the test item in rats of either sex was established as exceeding 5000 mg/kg body weight.
Acute dermal toxicity:
The study was carried out in accordance with OECD Guideline No. 402, "Acute Dermal Toxicity' and EEC Directive 84/449/EEC, Part B. 3, "Acute Toxicity - Dermal".
The test item was administered by dermal application, to five rats of each sex, at 2000 mg/kg body weight. Macroscopic examination was performed at the end of the experimental period.
No animals died during the study.
There were no clinical signs of toxicity or behavioural changes noted during the observation period.
All animals showed body weight gain over the study period.
The treated skin area showed in 1 male and 1 female erythema over the first 3 to 4 days. One female was noted with a scab on day 3 only. All animals showed blue staining of the treated skin by the test substance, which had disappeared by day 13.
Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities.
The dermal LD50 value of the test item in rats of either sex was established as exceeding 2000 mg/kg body weight.
Justification for classification or non-classification
Based on the information available for oral and dermal acute toxicity the substance resulted to be non toxic for both of them. Therefore according to the CLP Regulation n.1272/2008 table 3.1.1, it is not classified for acute toxicity.
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