Registration Dossier

Administrative data

Description of key information

A key primary skin irritation/corrosion study with J-37 in rabbits showed no irritating potential of the test substance. 
A key acute eye irritation/corrosion study with J-37 in rabbits showed no irritating potential to the eye in vivo.

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:

In a reliable primary skin irritation/corrosion study, the skin irritation/corrosion potential of J-37 was tested according to OECD 404 (NOTOX, 2010). Three rabbits were exposed to 0.5 grams of the test substance, moistened with water, by application onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48, and 72 hours after exposure.

No skin irritation was observed by 4 hours exposure to J-37. Red staining of the treated skin by the test substance was observed throughout the observation period which hampered the scoring of erythema on Day 1.

Eye Irritation:

A reliable acute eye/corrosion study was performed with J-37 according to OECD Guideline 405 (NOTOX, 2010). Single samples of approximately 32 mg of J-37 (a volume of approximately 0.1 mL) were instilled into one eye of three rabbits. Observations were made 1, 24, 48 and 72 hours after instillation. Instillation of the test substance resulted in effects on the iris and conjunctivae. Iridial irritation grade 1 was observed in all animals and had resolved within 24 hours. The irritation of the conjunctivae consisted of redness, chemosis and discharge and completely resolved within 48 hours in one animal and within 72 hours in the other two animals. Remnants of the test substance were present in the eye on Day 1 and the outside of the eyelids throughout the observation period. Red/purple staining of the fur on the head and paws, caused by the test substance, was noted throughout the observation period.

Justification for classification or non-classification

According to DSD and CLP classification criteria for skin and eye irritation, no classification is required for J-37.