Registration Dossier
Registration Dossier
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EC number: 915-790-0 | CAS number: -
Endpoint summary
Administrative data
Description of key information
The substance is of low acute toxicity in mammals by both the oral and dermal routes.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 380 mg/kg bw
- Quality of whole database:
- Sufficient to meet data requirements.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Sufficient to meet data requirements.
Additional information
The substance was tested as formulation (69% active) in an acute oral study in rats. The acute oral LD0 is > 2000 mg/kg test material (equivalent to 1380 mg/kg as active). An acute dermal study in rats on the pure technical substance gave a LD50 > 2000 mg/kg. Testing by the inhalation route is not scientifically justified.
Justification for selection of acute toxicity – oral endpoint
Only one study available. Study compliant with GLP and testing
guidelines.
Justification for selection of acute toxicity – inhalation endpoint
There is no study on inhalation toxicity available for the
substance. REACH stipulates that testing by the inhalation route is
appropriate if exposure of humans via inhalation is likely taking into
account the vapour pressure of the substance and/or the possibility of
exposure to aerosols, particles or droplets of an inhalable size. REACH
guidance R.7.a, chapter. 7.4 Acute toxicity, indicates that in principle
no inhalation studies are needed when vp < 0.1 Pa at 20°C or particle
size > 100 µm. The substance is a liquid or solid paste with a vapour
pressure estimated close to 0.21 Pa at 20°C (value is an overestimation
as it is based on a read-across with coco alkyl amine). Also the use of
this substance will not result in aerosols, particles or droplets of an
inhalable size, so exposure to humans via the inhalatory route will be
unlikely to occur, and no acute inhalation test was performed.
Justification for selection of acute toxicity – dermal endpoint
Only one study available. Study compliant with GLP and testing
guidelines.
Justification for classification or non-classification
The substance was only tested to 1380 mg/kg (as technical substance) however at this dose level there were no mortalities and only limited clinical signs. Hence it is likely that the LD50 lies above 2000 mg/kg. The dermal LD50 was clearly above 2000 mg/kg. This means that the substance does not meet the criteria for classification for acute toxicity by either the oral or dermal routes.
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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