Chlorhexidine dihydrochloride

Endpoint summary

Description of key information

Within a skin irritation study according to OECD Guideline 404, 3 Albino rabbits were treated with 0.5 g of the test substance moistened with 0.9 mL of Aqua demin to one intact and one scarified test site, which was occluded for 4 hrs after treatment. Scoring was done according to Draize 1, 24, 48 and 72 hrs after application. The treatment gave no indication for a dermal irritation potential and the PDII was calculated with 0.0. Edema and erythema scores were 0 in all animals at all time points.

In the eye irritation 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.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin 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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Remarks:

study performed prior to implementation of GLP

Species:

rabbit

Strain:

other: Albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: ASTA-Werke AG, Bielefeld
-Age at study initiation: 5-6 months
-Weight at study initiation: 2 - 2.2 KG
-Housing: single in stainless steel cages
-Diet: Standard ssniff(R); no feed at treatment day
-Water: ad libitum
-Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
-Temperature (°C): 22 +/- 1
-Humidity (%): 50-60
-Photoperiod (hrs dark / hrs light): 12 / 12

Type of coverage:

occlusive

Preparation of test site:

other: shaved and scarified

Vehicle:

water

Controls:

no

Amount / concentration applied:

Concentration: 0.5 g

Duration of treatment / exposure:

4 hrs

Observation period:

up to 14 days after treatment

Number of animals:

3

Details on study design:

TEST SITE
-Area of exposure: ca. 6.25 cm2
-% coverage: no data
-Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
-Washing (if done): no data

SCORING SYSTEM: Draize

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 1-72 hrs

Score:

0

Max. score:

8

Reversibility:

other: no effects observed

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

No edema or erythema noted. Scoring was 0 for each animal and time point of 1, 24, 48 and 72 hours after treatment. Primary score 0.0.

Other effects:

No systemic effects noted.

Interpretation of results:

GHS criteria not met

Conclusions:

The treatment gave no indication for a dermal irritation potential of chlorhexidine dihydrochloride.

Executive summary:

In this study according to OECD Guideline 404, 3 Albino rabbits were treated with 0.5 g of the test substance moistened with 0.9 mL of Aqua demin to one intact and one scarified test site, which was occluded for 4 hrs after treatment. Scoring was done according to Draize 1, 24, 48 and 72 hrs after application.

The treatment gave no indication for a dermal irritation potential and the PDII was calculated with 0.0.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Remarks:

study performed prior to implementation of GLP

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

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

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

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

5.5

Max. score:

20

Reversibility:

fully reversible within: 7 days

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

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

10.1

Max. score:

110

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available