Chlorhexidine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2002-01-17 to 2002-03-26

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Guideline study. The test was conducted using Chlorhexidine digluconate as test substance. As Chlorhexidine base is the active component, the results can be converted to equivalents of CHD-Base. Gluconate is not considered relevant compared to the effect of Chlorhexidine base.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)

EC Number:

242-354-0

EC Name:

D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)

Cas Number:

18472-51-0

IUPAC Name:

N',N'''''-hexane-1,6-diylbis[N-(4-chlorophenyl)(imidodicarbonimidic diamide)] - D-gluconic acid (1:2)

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: LPT, Hamburg
-Age at study initiation: ca. 5.5 months
-Weight at study initiation: 2.4 - 2.5 kg
-Housing: single
-Diet: ad libitum before and after exposure
-Water: ad libitum before and after exposure

ENVIRONMENTAL CONDITIONS
-Temperature (°C): 20 +/- 3
-Humidity (%): 55 +/- 15
-Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

500 mg/animal

Duration of treatment / exposure:

4 hours

Observation period:

up to 12 days after exposure

Number of animals:

3

Details on study design:

TEST SITE: Dorsal area of the trunk (6 cm2)
REMOVAL OF TEST SUBSTANCE: No residual test substance had to be removed after 4 hours
SCORING SYSTEM: As described in OECD Guideline 404
CONTROL: Surrounding untreated skin

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 - 72 hours after patch removal

Score:

1

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 - 72 hours after patch removal

Score:

0

Other effects:

There were no systemic intolerance  reactions.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

Under the conditions of the assay, rabbits exposed to chlorhexidine digluconate under semi-occlusive conditions for 4 hours showed only very slight (grade 1) and reversible erythema. Therefore, the substance can be classified as non irritating.

Executive summary:

Chlorhexidine digluconate was tested in an acute skin irritation test (patch test) in rabbits according to OECD guideline 404. There were only very slight (grade 1) and reversible erythema. Therefore, the substance can be classified as non skin irritating.