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Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
277 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

The oral administration of Patchouli Oil to rats by dietary admixture, at dose levels of

1300, 4000 and 13000 ppm (equivalent to a mean achieved dosage of 91.4, 277 and

810 mg/kg bw/day respectively) resulted in treatment related effects detected in adults

treated with 13000 ppm only. This dose level also resulted in a small number of

treatment related effects on offspring pre and post partum with an equivocal effect on the nature of some in utero parameters.

The ‘No Observed Effect Level’ (NOEL) for systemic toxicity was therefore considered to be 4000 ppm due to adult toxicity effects detected. The NOEL for reproduction and offspring development was 4000 ppm.


Short description of key information:
ORAL (DIETARY) REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 421)
EXPOSURE VIA INHALATION: NO DATA
EXPOSURE VIA DERMAL ROUTE: NO DATA

Effects on developmental toxicity

Description of key information
ORAL (DIETARY) REPRODUCTION/DEVELOPMENTAL TOXICITY SCREENING TEST IN THE RAT (OECD 421)
EXPOSURE VIA INHALATION: NO DATA
EXPOSURE VIA DERMAL ROUTE: NO DATA
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
277 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

The oral administration of Patchouli Oil to rats by dietary admixture, at dose levels of 1300, 4000 and 13000 ppm (equivalent to a mean achieved dosage of 91.4, 277 and 810 mg/kg bw/day respectively) resulted in treatment related effects detected in adults

treated with 13000 ppm only. This dose level also resulted in a small number of treatment related effects on offspring pre and post partum with an equivocal effect on the nature of some in utero parameters.

The ‘No Observed Effect Level’ (NOEL) for systemic toxicity was therefore considered to be 4000 ppm due to adult toxicity effects detected. The NOEL for reproduction and offspring development was 4000 ppm.


Justification for selection of Effect on developmental toxicity: via oral route:
Treatment effects on offspring pre and post partum were equivocal in nature.

Justification for classification or non-classification

The oral administration of Patchouli Oil to rats by dietary admixture, at dose levels of

1300, 4000 and 13000 ppm (equivalent to a mean achieved dosage of 91.4, 277 and

810 mg/kg bw/day respectively) resulted in treatment related effects detected in adults

treated with 13000 ppm only. This dose level also resulted in a small number of

treatment related effects on offspring pre and post partum with an equivocal effect on the nature of some in utero parameters.

The ‘No Observed Effect Level’ (NOEL) for systemic toxicity was therefore considered to be 4000 ppm due to adult toxicity effects detected. The NOEL for reproduction and offspring development was 4000 ppm

Classification according to Regulation (EC) No 1278/2008 is therefore not required.

Additional information