Registration Dossier
Registration Dossier
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EC number: 212-611-1 | CAS number: 831-82-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
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
- The maternal NOAEL is 50 mg/kgbw/day
- The foetal NOAEL is 200 mg/kgbw/day
- And 4-Phenoxyphenol was not considered to be embryotoxic, fetotoxic or teratogenic in the rat.
As indicated in the read-across justification data from Diphenyl Ether can be used for read-across to 4-Phenoxy Phenol systemic toxicological endpoints.
Therefore, the NOAEL and LOEAL determined in the rat prenatal study (OECD 414) for a mixture of Diphenyl Ether/ Biphenyl can be used for 4-Phenoxyphenol:
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See 2018_Read-across-Justification_V1 in attached justification - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 50 mg/kg bw/day (nominal)
- Based on:
- other: Diphenyl Ether
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 200 mg/kg bw/day (nominal)
- Based on:
- other: Diphenyl Ether
- Basis for effect level:
- body weight and weight gain
- Key result
- Abnormalities:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 500 mg/kg bw/day (nominal)
- Based on:
- other: Diphenyl Ether
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- Conclusions:
- As indicated in the read-across justification, data from Diphenyl Ether can be used for read-across to 4-Phenoxy Phenol systemic toxicological endpoints.
Therefore, the NOAEL and LOEAL determined in the rat prenatal study (OECD 414) for a mixture of Diphenyl Ether/ Biphenyl can be used for 4-Phenoxyphenol:
- The maternal NOAEL is 50 mg/kgbw/day
- The maternal LOAEL, based on body weight, is 200 mg/kgbw/day
- And 4-Phenoxyphenol was not considered to be embryotoxic, fetotoxic or teratogenic in the rat. - Executive summary:
As indicated in the read-across justification, data from Diphenyl Ether can be used for read-across to 4-Phenoxy Phenol systemic toxicological endpoints.
Therefore, the NOAEL and LOEAL determined in the rat prenatal study (OECD 414) for a mixture of Diphenyl Ether/ Biphenyl can be used for 4-Phenoxyphenol:
- The maternal NOAEL is 50 mg/kgbw/day
- The maternal LOAEL, based on body weight, is 200 mg/kgbw/day
- And 4-Phenoxyphenol was not considered to be embryotoxic, fetotoxic or teratogenic in the rat.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the Prenatal study, 4 -phenoxyphenol does not have to be classified according to the CLP regulation with regard to Reprotoxicity.
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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