Chlorhexidine dihydrochloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Remarks:

study performed prior to implementation of GLP

Test material

Test material information

Constituent 1

Reference substance name:

Chlorhexidine dihydrochloride

EC Number:

223-026-6

EC Name:

Chlorhexidine dihydrochloride

Cas Number:

3697-42-5

Molecular formula:

C22H30Cl2N10.2ClH

IUPAC Name:

chlorhexidine dihydrochloride

Test material form:

solid

Details on test material:

Chlorhexidindihydrochlorid
Chargen-Nr: 1/Dez. 83
CAS-Nr. 3967-42-5

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: 2.25 - 2.45 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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

4.6

Max. score:

80

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

5.5

Max. score:

20

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

10

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

10.1

Max. score:

110

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Irritant / corrosive response data:

corneal damage clouding (max. score 1 at day 1 and 2 in 1 animal); redding of conjunctiva (max. score 3 at 2 days in one animal), swelling of eye lids  (max. score 2 at 1 day in one animal), hypersecretion (max. score 2 at 2 days in one animal), all effects reversible within one week, total score 10.1 (72 h).

Other effects:

No systemic-toxic effects were observed.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

In this test chlorhexidine dihydrochloride was judged as slightly irritating. All effects were fully reversible within 7 days.

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 corneal damage clouding; redding of conjunctiva, swelling of eye lids, hypersecretion. All effects are reversible within one week. No systemic toxicity was observed. In this test chlorhexidine dihydrochloride was judged as slightly irritating. Classification in GHS category 2 is warrented.