Registration Dossier
Registration Dossier
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EC number: 200-385-7 | CAS number: 58-55-9
Endpoint summary
Administrative data
Description of key information
Skin: Rabbit, semiocclusive, clipped, 4 hours: not irritating (OECD 404, BASF AG 1986).
Eye: Rabbit (no rinsing): not irritating (comprable to OECD 405, BASF AG 1986).
The undiluted substance was not irritating to the eyes and in a 50% aqueous dilution not irritating to the skin of rabbits.
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
There are valid in vivo data available for the assessment of the skin and eye irritation potential of theophylline.
Skin irritation:
In a skin irritation study conducted by BASF AG (1986) according to the protocol of OECD 404, theophylline was applied in a 50 % aqueous formulation (w/w) to the clipped skin of White Vienna rabbits (two females, one male) with semiocclusive covering for 4 hours. After 4 hours an erythema score of 1 (very slight reddening) was determined in two females. No other signs of irritation (score 0) were noted after 24, 48 and 72 hours. Thus, theophylline was assessed to be not irritating to the skin.
Eye irritation:
In an eye irritation study performed by BASF AG, 1986 according to OECD guideline 405, the undiluted substance was applied to the eye of three White Vienna rabbits. The test substance was not washed out and induced mean scores of 0.6 for cornea opacity, 1.8 for conjunctival redness, 0 for iris, and 0.6 for swelling during the relevant reading period (24 -72 h). On day 8, one of 3 animals showed opacity score 1 and conjunctivitis score 2 and had also keratitis. The effects could possibly be due to mechanical irritation by the crystalline test substance.
Based on the results, theophylline was assessed not to be irritating to the eye.
Respiratory system:
No data available.
Conclusion: The undiluted substance was not irritating to the eyes. The substance in a 50% aqueous dilution was not irritating to the skin of rabbits.
Justification for classification or non-classification
Based on the results of the available skin and eye irritation studies, theophylline has not to be classified as skin or eye irritant according to requirements of the EU Annex VI of directive 67/548/EEC and GHS.
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