Registration Dossier
Registration Dossier
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EC number: 440-780-3 | CAS number: -
Endpoint summary
Administrative data
Description of key information
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
- Quality of whole database:
- GLP onducted with international guideline
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Assessment of acute oral toxicity in the rat (Acute Toxic Class Method).
The study was carried out based on the guidelines described in: EC Commission Directive
96/54/EC, Part B.1 tris "Acute Toxicity-Oral, Acute Toxic Class Method" and OECD No.423,
"Acute Oral Toxicity - Acute Toxic Class Method".
The substance was administered by oral gavage to three Wistar rats of each sex at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15).
No mortality occurred.
Piloerection, hunched posture and/or diarrhoea was noted among females on day 1, and lethargy and/or diarrhoea was noted among males on day 1 or 2.
Black discolouration and/or staining of various body parts, black faeces and/or purple urine was noted in all animals during the study period.
The body weight gain shown by the animals over the study period was considered to normal.
No abnormalities were found at macroscopic postmortem examination of the animals. The oral LD50 value of test item in Wistar rats was established to exceed 2000 mg/kg body weight.
Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), BLUE MOP 6314 does not have to be classified and has no obligatory labelling requirement for oral toxicity.
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008) acute toxicity means those adverse effects occurring following oral or dermal administration of a single dose of a substance or a mixture, or an inhalation exposure of 4 hours.
The LC50 value for the oral and dermal administration is higher then 2000 mg/kg bw (LD50 > 2000 mg/kg bw) that is the trigger value for the acute oral toxicity classification.
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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