Registration Dossier
Registration Dossier
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EC number: 406-040-9 | CAS number: 125643-61-0
Endpoint summary
Administrative data
Description of key information
Summary of acute toxicity
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Testing on the above endpoints gave the following results for the parameters tested:
Acute toxicity: Oral: LD50:
Two studies are available for this endpoint:
1) LD50 >2000 mg/kg (K1 study)
2) LD50 > 5000 mg/kg (K3 study).
For the purposes of risk assessment, the lower value is taken; however neither value is indicative of toxicity by oral ingestion.
Acute toxicity: Dermal:
Two studies are available for this endpoint:
1) LD50 >2000 mg/kg (K1 study)
2) LD50 >2000 mg/kg (K3 study).
For the purposes of risk assessment, the lower value is taken; however neither value is indicative of toxicity by dermal application.
Acute toxicity: Inhalation: Not measured.
The substance is of sufficiently low vapour pressure to preclude exposure via inhalation at significant volumes. In addition, production and use is done in a controlled process precluding the substance forming aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. This is also applicable to the use of the substance. Dermal exposure is considered to be the appropriate route of exposure and has been assessed accordingly. No acute inhalation test was performed.
The following information is taken into account for any hazard / risk assessment:
Oral, inhalation and dermal acute toxicity are all considered.
Value used for CSA:
LD50 (oral): 2000 mg/kg bw
LD50 (dermal): 2000 mg/kg bw
Justification for classification or non-classification
The above studies have all been ranked reliability 1 to 3 according to the Klimish et al system. This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols. The majority of the information has been provided from a migrated NONS file referring to studies, which are more than 12 years old, with the permission of ECHA.
The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for acute effects is therefore required.
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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