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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

In a GLP compliant OECD TG 404 study, 500 mg pasty dodecylamines (Genamin 12R 100 D) were semi-occlusively applied to the shaved skin of six New Zealand White rabbits for 3 minutes exposure time. After that in 3 animals the treated skin sites were rinsed with water and in the other 3 animals with 3% acetic acid solution followed by water. Both treatments caused moderate to severe erythema and oedema. An epidermal necrosis was noted quickly in the animals rinsed with water (24 h), which appeared delayed on Day 4 (1 animal) and 5 (2 animals) when the skin was rinsed with a 3% acetic acid solution, then water. Recovery developed in all animals rinsed with acetic acid solution. The skin was normal but dry in 2 animals on Day 10 and in the last animal on Day 14, when rinsing was performed with a 3% acetic acid solution, when water. The recovery occurred only in 1 animal when rinsed with water on Day 14. An epidermal necrosis was still present in 2 out of 3 animals rinsed with water at the end of the observation period
No oedema was observed in the animals from Day 7, for both rinsing procedures
Under these experimental conditions, the test substance dodecylamines (Genamin 12R 100 D) was considered to be corrosive.

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

The most prominent toxic property of the primary alkylamines in general is their strong irritative / corrosive properties, which can be attributed to their basicity. In this respect, dodecylamines show good comparability which support the general use of read-across principles. There are no human data on acute local toxicity for dodecylamines nor for any of the other primary alkylamines considered a chemical category available. In animals, data from all primary alkylamines demonstrated a significant dermal irritative potential of this chemical category. Dodecylamines as well as C12 -18 -(even numbered)-alkylamines, tallow 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

Dodecylamines fulfill the requirements for classification as Corrosive with the designation R35 - causes severe burns. Additionally, based on data from inhalation studies classification as Xi, R37 - irritating to respiratory system is indicated. Based on the dermal corrosive properties no testing for eye irritation was performed.