Registration Dossier

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Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

An OECD guideline 443 study in rats on the registered substance is planned according to the final decision of ECHA (Decision number: CCH-D-2114366659-31-01/F).

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information

OECD 414 (gavage) in rats:


NOAEL for maternal toxicity = 175 mg/kg bw/day


 


An OECD guideline 414 study in rabbits on the registered substance is on-going according to the final decision of ECHA (Decision number: CCH-D-2114366659-31-01/F).


Effect on developmental toxicity: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
175 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Study conducted according to the latest OECD guideline 414 and in compliance with GLP
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

In a prenatal developmental toxicity study performed according to OECD Guideline 414 and in compliance with GLP, three groups of 20 females received delta-3-carene at doses of 90, 175 or 350 mg/kg/day by oral gavage administration, from Day 6 to 19 after mating. A similarly constituted Control group received the vehicle, corn oil, at the same volume dose as the treated groups. Animals were killed on Day 20 after mating for reproductive assessment and fetal examination.


Clinical observations, body weight and food consumption were recorded. Adult females were examined macroscopically at necropsy on Day 20 after mating and the gravid uterus weight recorded. All fetuses were examined macroscopically at necropsy and subsequently by detailed internal visceral examination or skeletal examination.


 


The mean concentrations of delta-3-carene in test formulations analyzed for the study were within ±8% of nominal concentrations, confirming accurate formulation.


Transient chin rubbing was evident at 90, 175 or 350 mg/kg/day and was attributed to poor palatability ofdelta-3-carene.


A treatment related loss in body weight was evident after the first administration at 90, 175 or 350 mg/kg/day and subsequent body weight gain during Days 14-20 of gestation at 350 mg/kg/day and food intake at 175 or 350 mg/kg/day were low. Food intake was marginally low at 90 mg/kg/day during Days 6-10 of gestation.


Adjusted body weight change was low or markedly low at 175 or 350 mg/kg/day and gravid uterine weight was marginally low at 350 mg/kg/day.


 


Oral gavage administration of delta-3-carene resulted in small body weight loss following the first dose at 90, 175 or 350 mg/kg/day and subsequent low weight gain (-24%) and food intake at 350 mg/kg/day. Therefore, the No-Observed-Adverse-Effect-Level (NOAEL) for maternal toxicity was 175 mg/kg/day.


 


An OECD guideline 414 study in rabbits on the registered substance is on-going according to the final decision of ECHA (Decision number: CCH-D-2114366659-31-01/F).

Justification for classification or non-classification

An OECD guideline 443 study is planned to assess the potential effects of the registered substance on reproductive parameters.

Additional information

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