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Neurotoxicity

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Description of key information

Using a read-across approach with the substance 9-decenoic acid, methyl ester, the test material 9-dodecenoic acid, methyl ester is not expected to be a neurotoxicant. No evidence of systemic toxicity (including neurotoxicity) of 9-decenoic acid, methyl ester was observed in 28-day and 90-day repeated dose toxicity studies at doses up to 1000 mg/kg bw/day (the highest dose tested). 

Key value for chemical safety assessment

Effect on neurotoxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat

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

The repeated dose toxicity of the test item 9-dodecenoic acid, methyl ester via the oral route has been read-across from the substance 9-decenoic acid, methyl ester from the following studies:

A 28 day repeat dose oral toxicity study combined with a reproduction/ developmental toxicity screening test was performed in the rat in accordance with GLP and OECD Guideline 422 (Harlan Laboratories Ltd, 2012). The test item, 9-decenoic acid, methyl ester was administered by gavage to three groups, each of ten male and ten female Wistar Han™:RccHan™:WIST strain rats, for up to eight weeks (including a two week pre-pairing phase, pairing, gestation and early lactation for females), at dose levels of 30, 300 and 1000 mg/kg bw/day. There were no treatment related effects observed on behavioural assessment, functional performance tests or sensory reactivity assessments. Since no treatment-related effects were observed, a NOAEL for systemic toxicity (including neurotoxicity) was considered to be 1000 mg/kg bw/day.

A 90 day repeat dose oral toxicity study was performed in the rat in accordance with GLP and OECD Guideline 422 (WIL Research, 2015). 9-Decenoic Acid, Methyl Ester (9DAME), was administered orally by gavage once daily for a minimum of 90 consecutive days to Crl:CD(SD) rats. Dosage levels were 100, 300, and 1000 mg/kg/day. Mortality, clinical signs, body weight, food consumption, neurobehavioral parameters, ophthalmology, and clinical pathology parameters (hematology, coagulation, serum chemistry, and urinalysis) were monitored during the study. Complete necropsies were conducted on all animals, and selected organs were weighed at the scheduled necropsies. Selected tissues were examined microscopically. The subchronic oral administration of 9-decenoic acid, methyl ester (9DAME) to rats by gavage did not result in any toxicologically significant effects. There were no treatment related effects observed on functional observational battery parameters or on motor activity. The subchronic NOAEL for systemic toxicity, including neurotoxicity, is therefore considered to be 1000 mg/kg bw/day.


Justification for selection of effect on neurotoxicity via oral route endpoint:
The effects on neurotoxicity of the test item 9-dodecenoic acid, methyl ester (9DDAME) via the oral route has been read-across from studies conducted with the substance 9-decenoic acid, methyl ester (9DAME). This study was conducted according to OECD Guideline 408 and to GLP and is adequately reported. As such the study has been assigned a reliability 1.

Justification for classification or non-classification

No systemic toxicological findings, including no evidence of neurotoxicity, were detected in rats after repeated administration of 9-decenoic acid, methyl ester (9DAME) by the oral route at dose levels up to 1000 mg/kg bw/day for periods of 28 or 90 days. Based on these results, using a read across approach, 9-dodecenoic acid, methyl ester (9-DAME) does not warrant classification for neurotoxicity according to the criteria described in Regulation (EC) No 1272/2008.