Registration Dossier

Administrative data

Description of key information

Benzoic acid isononylbenzoate is slightly irritating in an acute dermal irritation/corrosion study as well as in an acute eye irritation/corrosion study:
Acute dermal irritation/corrosion: primary irritation index = 2
Acute eye irritation/corrosion: maximum mean group score = 10

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 (irritating)

Additional information

Acute Dermal Irritation/Corrosion:

The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following guidelines: OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 24 April 2002) and Commission Directive 92/69/EEC Method B4 Acute Toxicity (Skin Irritation). A single 4-hour, semi-occluded application of the test material to the intact skin ofthree rabbits produced very slight to well-defined erythema and very slight oedema. Moderate desquamation was also noted. All treated skin sites appeared normal at the 14-day observation.

The test material produced a primary irritation index of 2.0 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. The test material did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations CLP regulation 1272/2008/EC.

Acute Eye Irritation/Corrosion:

A single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. One treated eye appeared normal at the 24-hour observation and the remaining two treated eyes appeared normal at the 72-hour observation.

The test material produced a maximum group mean score of 10.0 and was classified as a mild irritant (Class 4 on a I to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The test material did not meet the criteria for classification as irritant according to EU labelling regulations CLP regulation 1272/2008/EC.


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

EU classification according to Annex VI of Directive 67/548/EEC: no classification required

GHS classification (CLP regulation 1272/2008/EEC): no classification required

The test material produced a primary irritation index of 2.0 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. The test material did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Commission Directive 2001/59/EC.

The test material produced a maximum group mean score of 10.0 and was classified as a mild irritant (Class 4 on a I to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC.