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Toxicological information

Eye irritation

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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:
data from handbook or collection of data
Justification for type of information:
data is from authoritative database

Data source

Reference
Reference Type:
other: AuthHSDBoritative database
Title:
HSDB for the Test chemical
Author:
US NATIONAL LIBRARY OF MEDICINE
Year:
2003
Bibliographic source:
Hazardous Chemical Databank [HSDB],US NATIONAL LIBRARY OF MEDICINE

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To determine the eye irritation potential of the test chemical in rats
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Chlorcyclizine hydrochloride
EC Number:
238-335-1
EC Name:
Chlorcyclizine hydrochloride
Cas Number:
14362-31-3
Molecular formula:
C18H21ClN2.ClH
IUPAC Name:
chlorcyclizine hydrochloride
Test material form:
solid
Details on test material:
Name of the test chemical: Chlorcyclizine hydrochloride
Molecular Formula: C18H21ClN2.ClH
Molecular Weight: 337.2918 g/mol
Substance type: Organic

Test animals / tissue source

Species:
rat
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
high dose - dose not specified
Duration of treatment / exposure:
several weeks- exact duration not mentioned
Observation period (in vivo):
several weeks- exact duration not mentioned
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
no data available
Details on study design:
no data available

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: several weeks
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
The test chemical has shown experimentally to induce lipidosis of the retinal pigment epithelium and the sensory retina in rats when fed in high dosage for several weeks
Other effects:
no data available

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The test chemical has shown experimentally to induce lipidosis of the retinal pigment epithelium and the sensory retina in rats when fed in high dosage for several weeks.
Hence,it can be considered to be irritating to eyes.
Executive summary:

The eye irritation potential of the test chemical was assessed in rats

The test chemical has shown experimentally to induce lipidosis of the retinal pigment epithelium and the sensory retina in rats when fed in high dosage for several weeks.

Hence,it can be considered to be irritating to eyes.