Registration Dossier

Administrative data

Description of key information

Based on read-across, D6N is a mild eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin Irritation resutls for the read-across substance:

Study Design: A group of 3 male rabbits received a single four-hour application of 500mg D6N-acetate to the shorn flank. The animals were assessed for up to 3 days for any signs of skin irritation.

Results: Very slight erythema was seen on the day of dosing only in two of the animals. No other signs of irritation were seen.

Conclusion: D6N-acetate is practically non-irritant following a single four-hour application to rabbit skin.

Eye Irritation resutls for the read-across substance:

Study design: D6N-acetate (100 mg) was applied into one eye of each of three rabbits and an assessment of initial pain was made.

 The eyes were examined for up to 3 days, to assess the grade of ocular reaction. 

 Results: Application into the eye caused practically no, or slight initial pain (class 1 to 2 on a 0-5 scale). Approximately ¼ to 1/3 of the test substance was displaced from the eye immediately after dosing.  No corneal or iridial effects were observed. Conjunctival effects were limited to slight redness, slight chemosis and slight to moderate discharge, which had completely regressed by day 3. 

No other signs of irritation were seen.

Conclusion:  D6N-acetate is a mild irritant (class 4 on a 1-8 scale) to the rabbit eye.


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Based on read-across data from Delta-6-nandrolone acetate, delta-6-nandrolone is classified as follows:

 

Eye Irrit.2                              H320:Causes Eye Irritation