Registration Dossier
Registration Dossier
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EC number: 944-610-3 | CAS number: 286472-48-8
Endpoint summary
Administrative data
Description of key information
Skin corrosion (OECD TG 431): non-corrosive
Skin irritation (OECD TG 439): Causes Skin Irritation - Category 2
Skin irritation in rabbit (OECD TG 404): moderate irritation -- Category 3 uner GHS, no classification warratned under CLP
Eye irritation in BCOP (OECD TG 437): not requireing classification
Eye irritation in rabbit (OECD TG 405): no classification warranted
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:
In vitro tests
The skin irritancy of the test substance, FRET 05 -0293 was determined according to OECD Guideline 439 using the EPISKIN™ Reconstructed Human Epidermis Model. The relative mean viability of the test item treated tissues was 40.6 % after a 15-Minute exposure period and 42 hours post-exposure incubation period. This result shows that the substance is a skin irritant, according to EU CLP criteria.
The skin corrosivity of the test substance was determined according to OECD Guideline 431 using the EpiDerm™ Reconstructed Human Epidermis Model. The relative mean viability of 3 and 60 minute exposures were above 50 and 15% respectively in relation to the control. Therefore the substance is not corrosive to skin, according to EU CLP criteria.
In vivo tests
The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit, according to OECD TG 404.
A single 4 Hour, semi occluded application of the test item to the intact skin of two rabbits produced well-defined erythema and slight edema. Other skin reactions noted were loss of skin elasticity, crust formation and slight desquamation. No corrosive effects were noted.
The test item produced a primary irritation index of 4.0 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme.
The test item meets the criteria for classification as a Mild irritant (Category 3) according to the Globally Harmonized System of Classification and Labelling of Chemicals.
The test item does not meet the criteria for classification according to Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
Eye irritation:
In vitro test
The test item FRET 05 -0293 was tested for eye irritation or serious eye damagaccording to OECD Test Guideline 437 (Bovine Corneal Opacity and Permeability Assay". The result indicated
the test item as "No category" thus not requiring classification to UN GHS or EU CLP.
In vivo test:
The study was performed conducted according to OECD Test Guideline 405 to assess the irritancy potential of the test item, FRET 05-0293, to the eye of the New Zealand White rabbit.
A single application of the test item to the non-irrigated eye of two rabbits produced moderate conjunctival irritation. One treated eye appeared normal at the 72-Hour observation and the other treated eye appeared normal at the 7-Day observation.
The test item produced a maximum group mean score of 9.0 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandraclassification system.
The test item does not meet the criteria for classification according to theGlobally Harmonized Systemof Classification and Labelling of Chemicals or to Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
Justification for selection of skin adn eye irritation / corrosion
endpoint:
The results of the studies are reliable and adequate for covering
the endpoint.
Effects on skin irritation/corrosion:moderate irritating category
3 under GHS, no need classification under CLP.
Effects on eye irritation/corrosion: no need classification under CLP.
Justification for classification or non-classification
Based on the results in the skin and eye irritation/corrosive tests the substance does not need classification according to EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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