Registration Dossier

Administrative data

Description of key information

Skin irritation studies of sufficient quality and conducted in a method comparable to OECD guideline 404 showed that the test substance was corrosive to rabbit skin. 
An eye irritation study of sufficient quality and conducted in methods comparable to OECD guideline 405 showed that the test substance was corrosive to rabbit eyes.
pH value of 11.7 indicated that the test substance was corrosive.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In one skin irritation study of sufficient quality and tested with methods similar to OECD guideline 404, 0.5 mL test substance was applied to the intact skin of rabbits. Animals were observed at 4 and 44 hours after treatment. Signs of necrosis were visible in two of six rabbits at the 4 hour reading and in five of six rabbits at the 44 hour observation period.

In another skin irritation study tested with methods similar to OECD guideline 404. 0.5 mL test substance was applied to non-abraded and abraded skin of rabbits. Animals were observed at 24 and 72 hours after treatment. The primary dermal index was determined to be 6.54 indicating corrosivity.

In a similar study, 0.5 mL test substance was applied to non-abraded and abraded skin of rabbits for 1 hour. Animals were observed 72 hours after treatment. The primary dermal index was determined to be 6.4. The degree of second degree chemical burn was moderate and diffuse.

In a skin irritation study conducted in methods comparable to OECD guideline 404, 0.5 ml test substance was applied directly on the intact skin sites. Animals were observed at 3 and 60 minutes and 4 hours after treatment. No signs were observed at the 1-3 minute observation period. Slight to moderate erythema was observed at the 60 minute and 4 hour observation periods. Signs of necrosis were visible in one animal at the 4 hour observation period.

In one eye irritation study of sufficient quality and tested with methods similar to OECD guideline 405, 0.1 ml of the test substance was instilled into one eye of each rabbit. The ocular reactions were graded at 1, 24, 48 and 72 hours and again at 7 days. If any corneal score was present on day 7, the eyes were scored again at 14 days. The maximum mean total scores (MMTs) were 41.3, 55.7, 66.6, 61.4, 57.3, and 72 at 1h, 24h, 48h, 72h, 7 day, and 14 day, respectively. Cornea and conjunctivae effects were not reversible within 14 days. The test substance was corrosive to rabbit eyes.

Available skin and eye irritation studies indicated that the test substance is corrosive.


Justification for selection of skin irritation / corrosion endpoint:
Reliable in vivo skin irritation study, supported by two other studies

Justification for selection of eye irritation endpoint:
Only one reliable study available

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the available data, a classification category 1C is warranted for skin irritation/corrosion.

Based on the available data, a classification category 1 (serious eye damage) is warranted for eye irritation.

No study is available on respiratory irritation. Data for classification is lacking.