Tolperisone

Eye irritation

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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

1

Reference substance name:

2,4'-dimethyl-3-piperidinopropiophenone hydrochloride

EC Number:

222-876-5

EC Name:

2,4'-dimethyl-3-piperidinopropiophenone hydrochloride

Cas Number:

3644-61-9

Molecular formula:

C16H23NO.HCl

IUPAC Name:

1-[2-methyl-3-(4-methylphenyl)-3-oxopropyl]piperidinium chloride

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

In vivo

Results

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.