Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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.

Diss Factsheets

Administrative data

Description of key information

Skin irritation:  

Skin irritation potential was determined by a  GLP study, comparable to current guidelines with the exception of the observation period of 3 days rather than the required 14 days.

Eye Irritation:

Eye irritation potential was investigated by a well documented GLP study which is comparable to current accepted guidelines.

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)

Additional information

Skin Irritation:

Based upon the observations made in the Primary Dermal Irritation Study in rabbits, 6-APA (6-Aminopenicillinic Acid), was determined not to be a dermal irritant.

Eye Irritation:

The test material was determined to be a mild irritant (class 4 in the Modified Kay and Calandra system). The maximum Group mean score was 12.7. However All effects were reversible within 72 hours.

Effects on eye irritation: slightly irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification