Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Amount / concentration applied:
The test material of 0.1 g was placed into the conjunctival sac of the left eye of animal. The untreated right eye served for control purposes.
Observation period (in vivo):
The eyes were examined 1, 24, 48 and 72 hours and then one and two weeks after the application.

Results and discussion

Results of in vivo study
Remarks on result:
probability of mild irritation
Irritant / corrosive response data:
One our after the single application of Tolperisone hydrochloride severe redness, chemosis, and severely increased discharge were observed. The cornea was opaque (more than three quarters up to the whole part of the cornea).24 hours after the treatment the irritation of conjunctiva did not change, however, the degree of corneal opacity increased. One week after the treatment the sings of irritation were decreased and by the end of the two week post-observation period the treated eye of the animal was free of symptoms.

Applicant's summary and conclusion