Registration Dossier
Registration Dossier
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EC number: 209-968-0 | CAS number: 599-64-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
In a combined repeated dose and reproduction / developmental screening oral study performed per OECD Test Guideline 422 the parental LOEL in the rat was 300 mg/kg. The NOAEL for the F1 generation was determined to be 300 mg/kg/day.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- A single guideline compliant study conducted under GLP conditions is available. The quality of the database is therefore considered to be good.
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 toxicity was investigated in a combined repeated dose and reproduction / developmental screening study conducted per OECD Test Guideline 422 under GLP conditions (RTI International; Center for Life Sciences and Toxicology, 2005). The study exceeded the guideline by following the F1 offspring to adulthood and includes an assessment of neurologic function.
P-cumylphenol, administered by gavage once daily at 0, 5, 50 and 300 mg/kg/day to parental Sprague-Dawley rats (10/sex/group) by gavage in corn oil through pre-breed, mating, gestation and lactation and direct dosing to F1 offspring from weaning to scheduled sacrifice resulted in systemic toxicity (manifested as renal tubular necrosis) at 300 mg/kg/day in the parental males. The LOAEL was determined to be 300 mg/kg/day for parental males. A slight decrease in uterine implantations at 300 mg/kg/day in the parental females was noted; however, based on the lack of other associated effects on reproductive parameters and the screening nature of this study a LOEL for females was established at 300 mg/kg/day. No toxicity in the F1 offspring from birth through 7 weeks of post-weaning dosing were observed. The NOAEL for the Parental rats was determined to be 50 mg/kg/day and the NOAEL for the F1 generation was determined to be 300 mg/kg/day.
Effects on developmental toxicity
Description of key information
In a combined repeated dose and reproduction / developmental screening oral study performed per OECD Test Guideline 422 the parental LOEL in the rat was 300 mg/kg. The NOAEL for the F1 generation was determined to be 300 mg/kg/day.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- A single guideline compliant study conducted under GLP conditions is available. The quality of the database is therefore considered to be good.
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 toxicity was investigated in a combined repeated dose and reproduction / developmental screening study conducted per OECD Test Guideline 422 under GLP conditions (RTI International; Center for Life Sciences and Toxicology, 2005). The study exceeded the guideline by following the F1 offspring to adulthood and includes an assessment of neurologic function.
P-cumylphenol, administered by gavage once daily at 0, 5, 50 and 300 mg/kg/day to parental Sprague-Dawley rats (10/sex/group) by gavage in corn oil through pre-breed, mating, gestation and lactation and direct dosing to F1 offspring from weaning to scheduled sacrifice resulted in systemic toxicity (manifested as renal tubular necrosis) at 300 mg/kg/day in the parental males. The LOAEL was determined to be 300 mg/kg/day for parental males. A slight decrease in uterine implantations at 300 mg/kg/day in the parental females was noted; however, based on the lack of other associated effects on reproductive parameters and the screening nature of this study a LOEL for females was established at 300 mg/kg/day. No toxicity in the F1 offspring from birth through 7 weeks of post-weaning dosing were observed. The NOAEL for the Parental rats was determined to be 50 mg/kg/day and the NOAEL for the F1 generation was determined to be 300 mg/kg/day.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to reproductive and developmental toxicity.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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