Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
SKIN
Key study:- Sanders (2011c) 'CN-3384A: Acute dermal irritation in the rabbit' conducted in line with OECD Guideline 404 and EU Method B.4. The substance produced a Primary Irritation Index score of 0.0 and so is not considered to be a skin irritant.
EYE
Key study:- Sanders (2011d) 'CN-3384A: Acute eye irritation in the rabbit' conducted in line with OECD Guideline 405 and EU Method B.5. The substance produced a maximum group mean score of 6.0 at the one hour observation point which suggests that the substance would be considered an eye irritant of minimal severity.
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
The key study was performed in compliance with GLP and to OECD Guideline 404 and EU Method B.4 with a sufficient level of detail to assess the quality of the study. The study was performed to a good standard in line with an accepted, standardised guideline and was assigned a reliability score of 1 using the criteria for assessing data quality as set out in Klimisch (1997).
Eye
The key study was performed in compliance with GLP and to OECD Guideline 405 and EU Method B.5 with a sufficient level of detail to assess the quality of the study. The study was performed to a good standard in line with an accepted, standardised guideline and was assigned a reliability score of 1 using the criteria for assessing data quality as set out in Klimisch (1997).
Justification for classification or non-classification
The data do not indicate that any classification for irritancy is required.
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.
