Registration Dossier
Registration Dossier
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EC number: 482-220-0 | CAS number: 848301-69-9
Endpoint summary
Administrative data
Description of key information
Dermal irritation: The test material produced a primary irritation index of 0.0 and was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
Eye irritation: A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. One treated eye appeared normal at the 24-hour observation and the remaining two treated eyes appeared normal at the 48-hour observation. The substance does not meet the criteria to be classified as an eye irritant.
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
Dermal irritation:
The study was performed to assess the irritancy potential of the test material following a single, 4-hour, semi-occluded application to the intact rabbit skin. The method was designed to meet the requirements of OECD Guideline No. 404 "Acute Dermal Irritation/Corrosion" and Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 2004/73/EC.
No evidence of skin irritation or corrosion was observed during the study in three animals.
The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
Eye irritation:
The study was performed to assess the irritancy potential of the test material following a single application to the rabbit eye. The method was designed to meet the requirements of OECD Guideline No. 405 "Acute Eye Irritation/Corrosion" and Method B5 Acute Toxicity (Eye Irritation) of Commission Directive 2004/73/EC.
A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. One treated eye appeared normal at the 24-hour observation and the remaining two treated eyes appeared normal at the 48-hour observation.
Justification for classification or non-classification
Dermal irritation:
The test material does not meet the criteria for classifcation as a skin irritant according to EU CLP regulations.
Eye irritation:
The test material produced the following individual mean scores for opacity, iritis redness and chemosis, as required for classification according to the Globally Harmonised classification Scheme:
Rabbit Number: 67182
Opacity: 0.0
Iritis: 0.0
Conjunctival redness: 0.0
Chemosis: 0.0
Rabbit number: 67215
Opacity: 0.0
Iritis: 0.0
Conjunctival redness: 0.3
Chemosis: 0.0
Rabbit number: 67216
Opacity: 0.0
Iritis: 0.0
Conjunctival redness: 0.3
Chemosis: 0.0
The test material did not meet the criteria for classifcation as an eye irritant according to EU CLP regulations.
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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