Registration Dossier

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

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 foetal NOAEL is 200 mg/kgbw/day
  • And 4-Phenoxyphenol was not considered to be embryotoxic, fetotoxic or teratogenic in the rat.
Link to relevant study records
Reference
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:
read-across source
Reason / purpose:
read-across: supporting information
Qualifier:
according to
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.
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.