Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 224-208-8 | CAS number: 4247-02-3
Endpoint summary
Administrative data
Description of key information
Skin irritation (WoE: OECD 439, OECD 435): irritating
Eye irritation (OECD 437): corrosive
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There are two reliable studies on the skin irritancy potential of isobutyl 4-hydroxybenzoate. Skin irritation was tested in a guideline study according to OECD guideline 439 using reconstructed human epidermis (RHE) model (Eurlings, 2016). The relative mean tissue viability obtained after 15 min treatment with isobutyl 4-hydroxybenzoate compared to the negative control tissue was 9.7%. Since the mean relative tissue viability was below 50% after 15 min treatment isobutyl 4-hydroxybenzoate is considered to be irritant.
In an additionally performed Corrositex test according to OECD 435 no penetration of isobutyl 4-hydroxybenzoate was observed during the observation time of 65 min. Therefore, the substance is considered to be not corrosive (Westerlink, 2016).
There is one reliable study available on the eye irritancy potential (Eurlings, 2016). Isobutyl 4-hydroxyparaben was tested for its eye irritant properties on bovine corneas according to OECD Guideline 437. Treatment with isobutyl 4-hydroxybenzoate resulted in a mean in vitro irritancy score of 80 after 240 minutes of treatment. Therefore, the substance is considered to cause serious eye damage.
Justification for classification or non-classification
The available data on skin irritation meet the criteria for classification as Skin Irrit. 2 (H315) according to Regulation (EC) 1272/2008.
The available data on eye irritation meet the criteria for classification as Eye Dam. 1 (H318) according to Regulation (EC) 1272/2008.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
