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Administrative data

Description of key information

No specific guideline study was conducted to assess skin or eye corrosion/irritation. However, observations from the acute dermal toxicity study provided evidence of skin corrosion potential (reported in IUCLID dataset section 7.2.3).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

An acute dermal study was conducted in Sprague-Dawley Crl: CD(SD) BR rats to assess the toxicity potential of the test item, in accordance with the standardised OECD guideline 402 and EU method B.3, and in compliance with GLP (Yu P., 1997). The test item was tested undiluted at the doses of 250, 500 and 1000 mg/kg (at various volumes) administered by dermal route (semi-occlusive) on the body dorsal surface (ca. 6 x 5 cm) of groups of 1 male per dose. At the end of the 24-h exposure period, the residual test article was wiped off. Animals were clinically observed for 14 days following the treatment.

After removal of the dressing, skin oedema and cyanosis were observed in all animals. Skin crust was noted in the rat given 250 mg/kg from day 6 up to the end of the observation period. In this animal, skin focal scab was also seen at the end of observation period. Based on the effects observed, no further animals were treated.

The test article, when administered to rats as a single dose by dermal route, induced skin corrosion. This observation is in agreement with the suspected mode of toxic action of the test item, i.e. the local release of hydrogen fluoride which then could cause a corrosion of tissues (reported in IUCLID dataset section 7.2). Nevertheless, based on this solely data, it is not possible to determine the proper skin corrosive subcategory for the test substance classification. As a consequence, the test item is classified as Skin Corrosion Category 1 (H314) according to the classification criteria of Regulation (EC) No. 1272/2008 (CLP / EU GHS) and UN GHS. Moreover, based on the conclusions of the acute dermal toxicity study, the substance is considered to also cause serious eye damage and thus an eye irritation study is not necessary. Therefore, the test substance is also classified as Eye Damage 1 (H318) according to the classification criteria of Regulation (EC) No. 1272/2008 (CLP / EU GHS) and UN GHS.

In the acute inhalation study (IUCLID 7.2.2), animals showed signs of respiratory distress, and exaggerated breathing which may indicate respiratory irritation following administration of a corrosive substance. As there is a possible release of corrosive hydrogen fluoride locally following exposure, the test substance is suspected to be corrosive to the respiratory tract if inhaled, with supplemental hazard statement EUH071 (see in IUCLID dataset section 7.2).

Justification for classification or non-classification

The test article, when administered to rats as a single dose by the dermal route, induced skin corrosion. The test substance is classified as Skin Corrosion Category 1 (H314) and Eye Damage 1 (H318) according to the classification criteria of Regulation (EC) No. 1272/2008 (CLP / EU GHS) and UN GHS.

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