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EC number: 701-068-0
CAS number: 2156592-58-2
The test material Armeen C (C12-18-(even numbered)-alkylamines) was tested for acute oral toxicity in a GLP compliant study according to OECD test guideline 401. The test item was applied via gavage to Wistar rats at doses of 500, 1000, 1500 and 2000 mg/kg body weight in peanut oil as vehicle. Clinical signs following treatment included hunched posture, apathia, uncoordinated movements, reduced reflexes, salivation, piloerection and irregular breathing. Symptoms started shortly after dosing and were present until death or up to 7 days in survivors. An LD50 of 1300 mg/kg body weight (1240 mg for male rats and 1390 mg for female rats) was calculated. With regard to acute dermal toxicity, a LD50 value of greater 2000 mg/kg body weight from a guideline conform study on C12-18-(even numbered)-alkylamines can be assumed based on read-across. Data from an inhalation study with C12-18-(even numbered)-alkylamines indicate a 1hour LC50 greater 0.099 mg/L.
There are no human data on acute toxicity for C12 -18 -(even
numbered)-alkylamines nor for any of the other primary alkylamines
considered a chemical category with respect to chemical safety
assessment. In animals, data for all relevant exposure routes are
available. For the inhalation route, there exists one rat screening
study for C12 -18 -(even numbered)-alkylamines which did not indicate a
strong toxic potential for this class of compounds when applied at a
non-corrosive concentration. For the dermal route, one rat study
performed also with C12 -18 -(even numbered)-alkylamines has likewise
not revealed evident acute toxicity (LD50 > 2000 mg/kg body weight)
indicating no significant toxicity with regard to this endpoint. Studies
for the oral route are available for C12 -18 -(even
numbered)-alkylamines as well as for all category members of primary
alkylamines considered. For C12 -18 -(even numbered)-alkylamines a LD50
of 1300 mg/kg body weight was established. However, in another GLP
compliant acute oral toxicity study according to OECD TG 401 a LD50 of
greater 2000 mg/kg body weight was revealed. Comparable LD50 values
indicating moderate acute oral toxicity were revealed also for tallow
alkylamines and octodecenylamines, which may be explained, like for C12
-18 -(even numbered)-alkylamines, from the corrosive properties of the
tested substances. This view was also taken in the existing EU risk
assessment of primary alkylamines. Considering the apparently low
systemic toxicity of the primary alkylamines, no need for further
inhalative or dermal testing was seen.
C12 -18 -(even numbered)-alkylamines fulfill the requirements for
classification as Harmful with the designation R22 - harmful if
swallowed. No classification with regard to acute dermal toxicity and/or
acute inhalation toxicity is deducible.
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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