Registration Dossier

Administrative data

Description of key information

The test substance showed no skin and eye irritating potential under the test conditions choosen in two studies performed by CIBA-Geigy (No. 874135 and No. 874134, 1987). 

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)

Additional information

Skin irritation / corrosion

In the CIBA-Geigy study (GU Project No. 874135, 1987) the acute skin irritation / corrosion property of the test substance was determined after a single dermal administration to rabbits. The study was conducted according to the OECD-Guideline 404 (adopted: 1981). 0.5 g of the test substance was applied to a gauze patch (20 cm²) and moistened with distilled water containing 0.5 % methylcellulose. This patch and a control patch were applied to contralateral flanks (6 cm²) of 3 male New Zeeland white rabbits for 4 hours and loosely covered with aluminium foil. The animals were checked daily for systemic symptoms and deaths. Mean 24 - 48 - 72 hour scores were 0.11 and 0 for erythema and edema, respectively. Skin reactions were fully reversible within 48 hours. The body weight gains were as expected and no mortalities occurred. Concluding, the test substance revealed no skin irritating potential.

The results of the acute skin irritation / corrosion property of the test substance were supported by the findings of the study performed by Geigy (U. K.) Ltd. (No.9/69/S. L., 1969), conducted similar to the OECD guideline 404 after single dermal administration of the test substance to rabbits.

 

Eye irritation

In the CIBA-Geigy study (GU Project No. 874134, 1987), the acute eye irritation property of the test substance was determined after a single administration to 3 male New Zeeland white rabbits. The study was conducted according to the OECD-Guideline 405 (adopted: 1987). 0.1 ml (63 mg) of the test substance was placed into the conjunctival sac of the left eye of each animal; the right eye remained untreated and served as control. The animals were checked daily for systemic symptoms and mortality and eye irritation was evaluated according to Draize. The cornea, iris and chemosis scores were grade 0 in the mean over 24, 48 and 72 hours in all 3 animals. The conjunctivae score was grade 0.33 in the mean over 24, 48 and 72 hours in all 3 animals. The body weight gains were within the normal range and no mortalities occurred. Concluding, the test substance revealed no eye irritating properties.

The results of the acute eye irritation property of the test substance were supported by the findings of the study performed by Geigy (U. K.) Ltd. (No.7/69/S. L., 1969), conducted similar to the OECD guideline 405 after single administration of the test substance to rabbits.

Respiratory irritation

No data available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. 

Based on the data, classification for skin and eye irritation is not warranted.

 

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

The available experimental test data is reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008.

Based on the data, classification for skin and eye irritation / corrosion is not warranted under Regulation (EC) No.1272/2008.