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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The oral NOAEL (rat, 90 days) for 4-phenoxyphenol is 15 mg/kgbw/day. This NOAEL is based on a read-across approach with Diphenyl Ether.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic toxicity: oral
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:
data from handbook or collection of data
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
Key result
Dose descriptor:
NOAEL
Effect level:
ca. 15 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
female
Basis for effect level:
body weight and weight gain
Key result
Critical 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 determined in the rat dietary subchronic study (90 days) for Diphenyl Ether can be used for 4-Phenoxyphenol.
The NOAEL (rat, 90 days) for 4-phenoxyphenol is 15 mg/kgbw/day.
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 determined in the rat dietary subchronic study (90 days) for Diphenyl Ether can be used for 4-Phenoxyphenol.

The NOAEL (rat, 90 days) for 4-phenoxyphenol is 15 mg/kgbw/day.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
15 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
2 (read-across study)

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

On the basis of the key study, only a NOAEL (rat, oral, 90 days) for 4 -phenoxyphenol was determined. The LOAEL is expected to be superior as 15 mg/kgbw/day.

According the CLP regulation, the criteria to classify a substance in the category STOT-RE 2 (H373) is a LOAEL value between 10 and 100 mg/kgbw/day. With this study, it is not possible to determine if 4 -phenoxyphenol is classified or not.

However, the Diphenyl Ether REACH registration file (consulted in April 2018) indicated a NOAEL (oral, rat, 90 days) of 301 mg/kgbw/day (males) and 335 mg/kgbw/day (females). Based on this data, it is considered that the LOAEL is superior as 100 mg/kgbw/day and Diphenyl Ether is not classified for repeated toxicity. Therefore, by analogy 4-phenoxyphenol does not have to be classified according to the CLP regulation with regard to Specific Target Organ Toxicity - Repeated Exposure.