Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Acute toxicity after single oral application was tested in female rats, which received 2000 mg/kg bw (two groups of three females). All animals survived until the end of the study. The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, prone position, moving the bedding, ataxia, hunched posture, piloerection and half eyelid closure. All symptoms recovered within 1 day post-dose.

Throughout the 14-day observation period, the weight gain of the animals was within the normal range of variation for this strain.

At necropsy, no macroscopic findings were observed in any animal of any step.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
reliable without restriction

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Based on the results of the oral toxicity study performed with isobutyl 4 -hydrxybenzoate the LD50value for acute oral was considered to be greater than 2,000 mg/kg bw.

Justification for classification or non-classification

Due to the findings described in the acute oral toxicity toxicity study performed with isobutyl 4 -hydroxybenzoate (LD50oral in rats greater than 2,000 mg/kg bw) the test substance does not have to be classified as acute orally toxic. Therefore, the test item does not have to be classified as acute toxic.