Registration Dossier
Registration Dossier
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EC number: 226-970-7 | CAS number: 5580-57-4
Endpoint summary
Administrative data
Description of key information
Not irritating on rabbit skin (OECD 404)
Not irritating in rabbit eyes (OECD 405)
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:
Reliable data from several studies on skin irritation are available
for the test substance. These data reveal a very low skin irritation
potential of the test substance.
In a patch test with the test substance 0.5 g of the test substance was
applied under occlusive conditions to the intact and abraded skin of 6
rabbits (3/sex). The gauze patches were removed 24 hours after
application and the skin reaction was observed according to the Draize
method after 24, 48 and 72 hours, 4 days and 7 days. No signs of
irritation were evident on abraided and intact skin of the rabbits.
The average scores (animal 1-6, 24/48/72 h) for erythema and edema
were 0. Similar results were found in the supporting study. In this
study the skin reactions were only scored after 24 and 72 hours, but
no skin reactions were found after 24 and 72 hours.
Eye:
The eye irritation potential of the test substance was assessed in two studies similar to OECD guideline 405. In the key study (Ciba-Geigy Ltd., 1975) the test substance was tested in 6 rabbits (3 per sex) of the Russian breed. Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye. The right eye was left empty and served as a control. The eye of 3 animals were rinsed 1 minute after application with physiologic saline. The reaction was scored after 1 and 6 hours and 1, 2, 3, 6 and 8 days. Under the conditions of this experiment, the test substance was found to cause minimal irritation when applied to the rabbit eye mucosa. Rinsing the eyes following instillation was of little but assessable effect. No classification according to CLP requirements is necessary.
This conclusion was supported by another eye irritation study with 6 rabbits (3 per sex) of the English Silver breed (Ciba-Geigy Ltd., 1974). After application of 0.1 g of the test substance into the conjunctival sac of the left eye of the rabbits no effect were observed with or without washing within an observation periode of 7 days.
Justification for classification or non-classification
Classification, Labelling, and
Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data on skin irritation/corrosion and eye irritation, the
test item is not classified according to Regulation (EC) No 1272/2008
(CLP), as
amended for the thirteenth time in Regulation (EC) No. 2018/1480.
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