Registration Dossier
Registration Dossier
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EC number: 283-044-5 | CAS number: 84539-55-9
Endpoint summary
Administrative data
Description of key information
Two acute skin irritation/corrosion studies in albino rabbits were performed according to the OECD Guideline No. 404. Application of FeNaEDDHA to the rabbit skin was evaluated as not irritating in both studies. Two eye irritation studies, performed according to OECD Guideleine 405 with the test item FeNaEDDHA in rabbits, showed that the test substance does not cause eye irritation as none of the animals achieved a mean score leading to classification according to GHS and DSD.
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
Skin irritation
Two acute skin irritation/corrosion studies in albino rabbits were performed to determine the irritant or corrosive potency of the test substance FeNaEDDHA on the albino rat skin.These tests was based on the OECD Guideline 404 (Acute Dermal Irritation/Corrosion) and was performed on 3 rabbits, checked for normal skin conditions. A gauze patch bearing 0.5 g of the test article was applied to the right flank of each animal and held in place for 4 hours by an adhesive tape. The studies showed that FeNaEDDHA does not cause skin irritation, as the mean values of the recordings 24 to 72 hours after application were scored 0.
Eye irritation
Two eye irritation studies were performed according to the OECD Guideline 405 (Acute Eye Irritation/Corrosion) with the test item FeNaEDDHA. The test was performed on 3 rabbits. A volume of 0.1 mL of the test item was placed into the conjunctival sac of the left eye of each animal. The lids were then held together for about one second in order to prevent loss of the test article. The animals were checked daily for systemic symptoms and mortality. The studies showed that the test substance does not cause eye irritation as none of the animals achieved a mean score leading to classification according to GHS (>= 1 for cornea and iris; >= 2 for redness and chemosis) and DSD (>= 1 for iris; >= 2 for cornea and chemosis; <= 2.5 for redness).
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance does not need to be classified and labelled as eye or skin irritant under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EC) No 2016/1179.
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