Registration Dossier
Registration Dossier
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EC number: 265-477-1 | CAS number: 65122-06-7
Endpoint summary
Administrative data
Description of key information
Skin irritant and eye irritant based on the content of acetic acid, used as stabiliser, up to 25 %.
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
Justification for classification or non-classification
Due to the lack of experimental data, the evaluation on the irritation potential of Basic Red 014 acetate was based on its composition, in particular on classified components, as well as on read across data.
Acetic acid (10 -25 % w/w) is classified as skin irritant (H315) and eye irritant (H319) within the CLP Regulation (EC 1272/2008).
Read across studies reported no signs of irritation. In particular:
- as for skin irritation, since all animal tested showed no signs of erythema and oedema over 24, 48 and 72 hours, mean scores were below the threshold for classification, i.e. 2.3.
- as for eye irritation, classification was not attributed based on results and reliability of available studies. In the key study, average scores over 24, 48 and 72 hours were below the thresholds for classification, i.e. 1 for cornea and iris, and 2 for conjuctivae redness and chemosis, in at least 2 over 3 tested animals. Moreover, all signs were reversible within 21 days from exposure.
Two further studies of eye irritation were disregarded. One study (1979) was disregarded due to significant differences with respect to current recommendations, in terms of duration of the observation period (7 days instead of 21 days) and of eye rinsing. Both these aspects were expected to influence the outcome. Similarly, a second study (1993) was not included in the assessment, due to the limited number of animals (1 instead of 3), the short duration (sacrifice 48 h after application of the test substance to the eye) and the lack of eye rinse.
Overall, a classification as skin and eye irritant, i.e. H315 and H319, that accounts for the presence of acetic acid as stabiliser, was applied to Basic Red 014 acetate.
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