Registration Dossier
Registration Dossier
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EC number: 268-219-6 | CAS number: 68037-95-6 This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated alkyl amine and SDA Reporting Number: 11-029-00.
Endpoint summary
Administrative data
Description of key information
In a GLP compliant OECD TG 404 study, 0.5 ml tallow alkylamines (Genamin TA 100 D) were semi-occlusively applied to the shaved skin of one New Zealand White rabbits for 4 hours and three animals for 3 minutes exposure time. Both treatments caused moderate to severe erythema and oedema. Full thickness destruction of the epidermis had occurred after 7 days following the 4 hour exposure and after 14 days following exposure of 3 minutes. Based on the results, the test material is considered to be corrosive to skin.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
There are no human data on acute toxicity for tallow alkylamines nor for any of the other primary alkylamines considered a chemical category with respect to chemical safety assessment. In animals, data from all alkylamines demonstrated a significant dermal irritative potential of this chemical category. Tallow alkylamines as well as C12 -18 -(even numbered)-alkylamines and octadecenylamines were shown to be corrosive to rabbit skin, and, in consequence, not tested in rabbit eye. Hydrogenated tallow alkylamines and octadecylamines induced less severe effects in skin but caused severe eye irritation up to irreversible damage in the rabbit eye. For C12 -18 -(even numbered)-alkylamines, rat inhalation studies indicated irritative properties on the respiratory tract.
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: highly irritating
Effects on respiratory irritation: irritating
Justification for classification or non-classification
Tallow alkylamines fulfill the requirements for classification as Corrosive with the designation R35 - causes severe burns.
with R38 – irritating to skin. Additionally, based on data from the EU risk assessment report, which classifies C12-18-(even numbered)-alkylamines as irritating to respiratory tract, classification as Xi, R37 – irritation to respiratory system – is indicated for all other corrosive primary alkylamines based on read-across. Based on the dermal corrosive properties no testing for eye irritation was performed.
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