Registration Dossier

Administrative data

Description of key information

Skin irritation: not irritating after occlusive exposure (BASF 80/404, 1981), similar or equivalent to OECD 404, rabbit
Eye irritation: Slight reversible findings on cornea and conjunctivae, which are below the threshold of classification and labelling (BASF 80/404, 1981), similar or equivalent to OECD 405, 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:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion

In the BASF study (80/404, 1981) the acute skin irritation/corrosion property of the test substance was determined after a single dermal administration to rabbits. The study was conducted similar to the OECD-Guideline 404. Major differences to the OECD guideline are occlusive exposure and an exposure duration of 24h and not 4h. These conditions are more stringent than required and therefore, the test is considered adequate for hazard assessment. The test substance was suspended in water and occlusively applied to the intact and abraded skin of the upper third of the backs or flanks of 3 Vienna White rabbits each sex for 24 hours. Following exposure, the test material was washed off with water and the skin reaction was appraised after 24, 48, and 72 hours, as well as after 8 days on the basis of the Draize scoring system. Mean 24, 48, and 72 hour erythema score could not be determined due to the staining of the skin caused by the colored test substance. Mean 24, 48, and 72 hour edema score for all 6 animals was 0.2, and the effects were fully reversible within 72 hours. No further effects such as gross pathology were detected. The test substance was concluded to be not irritating to the skin under the test conditions chosen.

 

Eye irritation

In the BASF study (80/404, 1981), the acute eye irritation property of the test substance was determined after a single administration to 4 male and 2 female Vienna White rabbits. The study was conducted similar to the OECD-Guideline 405. A reliability of 2 is assigned because the study was not performed according to GLP. 0.1 mL bulk volume, corresponding to about 15 mg pulverized test substance, was placed into the conjunctival sac of the right eyelid of each animal; the other eye remained untreated and served as control. The eye irritation was evaluated according to Draize. One animal showed a mean 24, 48, and 72 hour cornea score of 0.33, which was fully reversible within 8 days, whereas the other 5 animals did not show any effects on the cornea. Additionally, none of the animals exhibited effects on the iris. Two animals were recorded with conjunctivae reactions (mean score over 24, 48, and 72 hours 0.33 and 0.67, respectively), which were fully reversible within 48 and 72 hours. The remaining 4 animals revealed conjunctivae scores of zero. None of the animals exhibited chemosis effects. The test substance was concluded to be not irritating to the eyes under the test conditions chosen.  

Respiratory irritation

No data available.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin or eye irritation under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008, as amended for the second time in Directive EC 286/2011.