Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

In a skin irritation study performed per OECD Test Guideline 404 and EPA OPPTS 870.2500 the substance was non-irritating in the rabbit.

In an eye irritation study performed per OECD Test Guideline 405 the substance caused irreversible cornea, iris and conjunctival effects on the eye in the rabbit.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

The skin irritation potential was investigated in a study performed per OECD Test Guideline 404 and EPA OPPTS 870.2500 under GLP conditions (Toxikon Corporation, 2002).

Three New Zealand White rabbits were dosed with 0.5 g of the neat test substance under semi-occlusive conditions for 4 hours.

Under the conditions of this study, PCP is considered to be a non-irritant.

An additional non-GLP dermal irritation study (Hüls, 1988) following OECD Test Guideline 404 was conducted using 3 rabbits. The Primary Dermal Irritation Index was 2.78. All effects were resolved by the end of the study and p-Cumylphenol was considered a mild irritant.

 

Eye irritation

The key study was conducted according to OECD method 405 (Hüls, 1988).

Three Russian rabbits were dosed with 0.1 g of the neat test substance and the eyes were examined at 1, 24, 48 and 72 hours and 6, 8, 10, 13, 17 and 21 days after the application.

Under the conditions of this study, PCP is considered to cause irreversible effects to the eye. The effects of the test substance on the eye increased over the 21 day observation period, particularly in the cornea.

 

The supporting study was conducted per OECD 405 and EPA OPPTS 870.2400 under GLP conditions (Toxikon Corporation, 2002).

Three New Zealand White rabbits were dosed with 0.1 mL of PCP per eye. Eye irritation scores were recorded at 1, 24, 48 and 72 hours post-dose. Following the 24-hour observation, the treated eyes were rinsed.

Under the conditions of this study, PCP is considered to be a non-irritant to the eyes of rabbits.

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 skin irritation.

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does require classification with respect to eye irritation as Category 1 (H318: Causes serious eye damage).