Registration Dossier
Registration Dossier
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EC number: 200-238-7 | CAS number: 55-56-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-09-04 to 1984-09-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Chlorhexidine
- EC Number:
- 200-238-7
- EC Name:
- Chlorhexidine
- Cas Number:
- 55-56-1
- Molecular formula:
- C22H30Cl2N10
- IUPAC Name:
- N',N'''''-hexane-1,6-diylbis[N-(4-chlorophenyl)(imidodicarbonimidic diamide)]
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
-Source: ASTA-Werke AG, Bielefeld
-Age at study initiation: 5 months
-Weight at study initiation: 2 - 2.2 KG
-Housing: single in stainless steel cages
-Diet: ad libitum
-Water: ad libitum
-Acclimation period: 1 day
ENVIRONMENTAL CONDITIONS
-Temperature (°C): 22 +/- 2
-Humidity (%): 55 +/- 15
-Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye used as control
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- single application / not rinsed
- Observation period (in vivo):
- up to 21 days after application
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
-Washing: not rinsed
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1h to 21 d
- Score:
- 52.9
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1h to 21 d
- Score:
- 13.8
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- Irreversible serious damage to cornea (partial or total clouding within 1 hour, increasing with time) and iris, permanent conjunctival hyperemia, hypersecretion.
- Other effects:
- No systemic toxicity
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information
- Conclusions:
- Risk of serious damage to eyes
- Executive summary:
In this study according to OECD Guideline 405, 3 Albino rabbits were treated with 0.1 g of the test substance. Scoring was done according to Draize and effects were recorded for up to 21 days. The treatment caused irreversible serious damage to cornea (partial or total clouding within 1 hour, increasing with time) and iris, permanent conjunctival hyperemia, and hypersecretion. No systemic toxicity was observed.
In this test chlorhexidine base was judged as corrosive.
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