Registration Dossier
Registration Dossier
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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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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:
- 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 Blue F08-0170 indicated that the test item is non irritant.
Eye irritation
The results of the in vitro eye irritation study in the isolated chicken eyes model with Reactive Blue F08-0170 indicated that the test item was not irritating.
The irritant effects of Reactive Blue F08 -0170 were evaluated according to the Draize method (OECD No.: 405, 2002) in an
acute eye irritation study performed in New Zealand White rabbits. Reactive Blue F08-0170, applied to the rabbits’ eye mucosa, caused significant conjunctival irritant effects at one hour after application, however, the effects were fully reversible within 24 hours. Discolouration of the conjunctivae was reversible within 48 hours.
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: Not irritating
Effect level: empty Endpoint conclusion: Adverse effect observed
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 no classification under the Dangerous Substance Directive (67/548/EEC) and the 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
