Registration Dossier
Registration Dossier
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EC number: 258-038-0 | CAS number: 52605-52-4
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:
- 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:
- 2 003
- 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
- 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
Constituent 1
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.
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