Registration Dossier

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:
read-across source
Reason / purpose:
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.