Registration Dossier
Registration Dossier
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EC number: 629-695-4 | CAS number: 164383-22-6
Endpoint summary
Administrative data
Description of key information
Irrittating to skin (GHS Cat.2)
Non-irritating to eyes
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
In a GLP compliant OECD TG 404 study, Tallow Nitrile was applied semi-occlusively for 4 hours to the shaved skin of three New Zealand White Rabbits. Well-defined up to moderate erythema and slight edema were observed in all three animals. All signs of irritation were fully reversible between day 7 and day 14 post application. Average scores for erythema were 2.7 (for 24h, 48h and 72h) in all animals. Scores for oedema were 1.0, 1.3 and 1.0 for the same time points. Based on the study results, the test material Tallownitrile is considered to be irritating to skin.
There are two studies available in which the eye irritation properties of Tallownitril has been evaluated according to OECD 405 and EU 84/449/EEC B.5 guidelines. Both studies conclude that Tallownitrile is not irritating to the eyes.
Effects on skin irritation/corrosion: irritating
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
Available information indicates that alkylnitriles are irritating to the skin, but not irritating to the eyes.
Dermal irritation:
An adequate guideline study with Tallownitrile has shown the substance to be irritating to skin.
A similar study performed with Dodecanenitrile resulted to similar results showing that also Dodecanenitrile is considered to be irritating to skin. (GHS Cat.2).
Other available dermal irritation studies other alkylnitriles also indicated dermal irritation but the actual scoring in those studies was not sufficient to reach a Cat.2 classification.
In view of the collective data on dermal irritation on the various alkylnitriles, the weight of evidence indicates that it is considered prudent to classify the alkylnitriles collectively as irritating to skin.
Eye irritation:
Although irritating to the skin, none of the in vivo eye irritation studies performed on the various alkyl nitriles, including Tallownitrile, indicated a concern for eye irritation.
Respiratory irritation:
There is no information on possible respiratory irritation. Based on the available information on skin and eye irritation, alkylnitriles are not expected to pose a great concern in this respect. Moreover, based on the very low vapour pressure and water solubility, respiratory irritation is not likely to occur.
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