Registration Dossier

Diss Factsheets

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.

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