Octylamine

Neurotoxicity

Description of key information

The neurobehavioral NOAEL was 150 mg/kg bw/day for male and female rats in the combined oral gavage OECD TG 422 study.

Key value for chemical safety assessment

Effect on neurotoxicity: via oral route

Link to relevant study records

Reference

Endpoint:

neurotoxicity: oral

Remarks:

other: combined repeated dose toxicity stud withteh reproduction/developmental toxicity screening test

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

2005-10-12 through 2007-07-30

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study, but as read-across from supporting substance maximum reliability is 2. Read-across hypothesis: for details please see read-across report in IUCLID section 13.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

other: OECD 422

Deviations:

no

GLP compliance:

yes

Limit test:

no

Species:

rat

Strain:

other: Crl:CD(SD)IGS BR

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

water

Analytical verification of doses or concentrations:

yes

Duration of treatment / exposure:

Males 47-48 days; females 42-46 days

Frequency of treatment:

7/week

Remarks:

Doses / Concentrations:
0, 37.5, 75, 150 mg/kg bw
Basis:
analytical conc.

No. of animals per sex per dose:

12

Control animals:

yes, concurrent vehicle

Dose descriptor:

NOAEL

Effect level:

150 mg/kg bw/day (actual dose received)

Sex:

male/female

Basis for effect level:

other: No substance-related changes in parental animals after 12 (males) and 13 (females) daily doses. Examinations: neurobehaviour; forelimb and hindlimb grip strength; open field observations; motor activity

Remarks on result:

other: Generation: maternal (migrated information)

Read-across hypothesis: for details please see read-across report in IUCLID section 13.

 

Conclusions:

The neurobehavioral NOAEL was 150 mg/kg bw/day for male and female rats in the combined oral gavage OECD TG 422 study.

Executive summary:

Potential effects of octylamine on neurobehaviour were examined in the combined repeated dose and reproduction/developmental toxicity study according to OECD TG 422 and under GLP conditions. Male and female rats (12 per group) were given 0, 37.5, 75, and 150 mg octylamine hydrochloride/kg bw/day by oral gavage, starting at 14 days prior to the mating period. The top dose was 150 mg/kg bw/day until the end of the premating period. Neurobehavioral evaluations were performed 7-8 days prior to the test substance administration, and after 12 (males) and 13 (females) doses towards the end of the premating period.

 

There were no test substance-related effects or statistically significant differences on forelimb or hindlimb grip strength, in the Open Filed Observation parameters, in either males or females administered 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. The lower motor activity was considered to be secondary to reduced food consumption and body weight gain.

 

Overal, the neurobehavioral NOAEL was therefore 150 mg/kg bw/day for male and female rats in the OECD TG 422 study (DuPont, 2007)

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

150 mg/kg bw/day

Study duration:

subacute

Species:

rat

Quality of whole database:

reliable guideline study with RA substance octylamine-HCl

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 TG 422 and under GLP conditions. Male and female rats (12 per group) were given 0, 37.5, 75, and 150 mg octylamine hydrochloride/kg bw/day by oral gavage, starting at 14 days prior to the mating period. The top dose was 150 mg/kg bw/day until the end of the premating period. Neurobehavioral evaluations were performed 7-8 days prior to the test substance administration, and after 12 (males) and 13 (females) doses towards the end of the premating period.

 

There were no test substance-related effects or statistically significant differences on forelimb or hindlimb grip strength, in the Open Filed Observation parameters, in either males or females administered 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. The lower motor activity was considered to be secondary to reduced food consumption and body weight gain.

 

Overal, the neurobehavioral NOAEL was therefore 150 mg/kg bw/day for male and female ratsin the OECD TG 422 study (DuPont, 2007)

Justification for selection of effect on neurotoxicity via oral route endpoint:
only study available

Justification for classification or non-classification

n-Octylamine has not to be classified for specific organ toxicity - neurotoxic effects according to Regulation (EC) No 1272/2008 because investigations with the RA substance n-octylamine hydrochloride did not show effects on neurotoxic endpoints up to concentrations which caused slight but non-adverse effects on body weight and food consumption.