Registration Dossier

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.