Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Summary of irritation data
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:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation / Corrosion.
The results of an in vitro skin irritation test in the EPISKIN model with Reactive Red F08-0146 indicated that the test item is non irritant.
Eye irritation.
The results of an in vitro eye irritation study in the Isolated Chicken Eyes model with Reactive Red F08-0146 suggested that the test item was slightly irritating.
In an in vivo eye irritation study performed in New Zealand White rabbits, the irritant effects of Reactive Red F08 -0146 were evaluated according to the Draize method (OECD No.: 405, 2002). Reactive Red F08-0146 applied to rabbit eye mucosa caused significant conjunctival and corneal irritant effects at one hour, which were reduced at 24 hours after application. All irritation effects were completely reversed after the 3-week observation period; however, discoloration of the cornea and the conjunctiva had not fully reversed within the observation period of 3 weeks.
Due to the not fully reversible staining effect on the cornea, Reactive Red F08-0146 requires classification as an eye irritant (Irreversible effects on the eye/serious damage to eyes (Category 1)) according to Regulation (EC) No 1272/2008.
Respiratory irritation
Respiratory irritation was not assessed; however no effects on the animals were noted in any associated studies.
The following information is taken into account for any hazard / risk assessment:
Skin and eye irritation are discussed.
Value used for CSA:
- Skin irritation / corrosion: Not irritating
- Eye irritation: Severe Irritant (based on staining of the eye)
Effects on eye irritation: irritating
Justification for classification or non-classification
The above studies have all been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP an in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.
The above results triggered classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008) as follows:
Dangerous Substance Directive (67/548/EEC): Xi – R41
CLP Regulation (EC No 1272/2008): Eye Damage 1 – H318
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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