Registration Dossier

Administrative data

Description of key information

SKIN IRRITATION 
Caffeine is not a dermal irritant.
EYE IRRITATION
Caffeine is not an eye irritant.

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

In a primary dermal irritation study (BASF, 1985), young adult Vienna White rabbits (2 males and 1 female) were dermally exposed to approximately 500 mg of Caffeine (purity not given) in water for 4 hours to an area of the flanks sized approximately 2.5 cm x 2.5 cm. Animals then were observed for 3 days. Irritation was scored by the method of Draize.

No erythema, no edema, and no other finding was observed. All scores were zero for each endpoint in each animal at any reading. No other symptoms or findings were noted. In this study, Caffeine is not a dermal irritant.

EYE IRRITATION

In a primary eye irritation study (BASF, 1985), 0.1 ml bulk volume (ca. 56 mg) of unchanged, comminuted Caffeine (purity not given) was instilled into the conjunctival sac of the right eye of young adult Vienna White rabbits (2 males and 1 female) without rinsing. Animals then were observed for 8 days. Irritation was scored by the method of Draize.

Very slight corneal opacity, slight to well-defined conjunctivae redness, and slight to well-defined necrosis were noted. In one animal, corneal opacity and conjunctivae redness was not fully reversible within 8 days; the eyes of the other 2 animals were normal by day 8. Mean scores (mean of 3): 0.9 (cornea), 0.0 (iris), 1.6 (conjunctivae redness), 0.6 (chemosis). In this study, Caffeine is not an eye irritant.

Justification for classification or non-classification

There is no need to classify Caffeine for skin or eye irritation according to the Directive 67/548/EC or GHS criteria.