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Neurotoxicity

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Description of key information

No valid neurotoxicity studies for 2-ethylhexylamine are available. However, a read-across to a reproduction/developmental toxicity screening test according to OECD guideline 422 with octylamine hydrochloride is available (ACC, Oxea Group 2007) in which neurobehavioural observations were included. There were no treatment related effects or statistically significant differences on forelimb and/or hindlimb grip strength. In the open field observation no changes were seen in any dosage of the test substance analogue. Regarding motor activity, there was a trend of reduced number and duration of movements in males and females compared with controls at 150/100 mg/kg bw/day which seems to be related to a general bad condition of the animals. The neurobehavioral NOAEL was therefore 100 mg/kg bw/day for male and female rats in the OECD TG 422 study. 

Key value for chemical safety assessment

Effect on neurotoxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
100 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Reproduction/developmental screening test according to Guideline study and performed under GLP conditions in which neurobehavioural observations were included.

Effect on neurotoxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Effect on neurotoxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Potential effects of octylamine on neurobehavior were examined in the combined repeated dose and reproduction/developmental toxicity study according to OECD 422. Male and female rats were given 0, 37.5, 75, and 150 mg octylamine hydrochloride/kg bw/day by oral gavage, starting 14 days prior mating. The dose level was decreased to 100 mg/kg bw/day after premating period (day 14) due to mortalities (3 animals); autopsy suggested an intubation accident aggravated by the irritation from the test substance.

There were no treatment related effects or statistically significant differences on forelimb or hindlimb grip strength. In the open field observation no changes were seen at any dosage of the test substance. Regarding motor activity, there was a trend of reduced number and duration of movements in males and females compared with controls at 150/100 mg/kg bw/day. No treatment related changes in grip strength, response to tail pinch, approach and touch and auditory stimulus parameters were seen. Since mortality, effects on body weight, food consumption, and clinical observations occurred at 150/100 mg/kg bw/day, the lower motor activity seems to be related to a general bad condition of animals than to neurotoxic effects of the test substance. The neurobehavioral NOAEL was therefore 100 mg/kg bw/day for male and female rats in the OECD 422 study (ACC, Oxea group 2007).

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified with respect to neurotoxicity after repeated dosing via oral route under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EU) No 2016/1179.