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Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 hours after patch removal
Score:
1
Reversibility:
fully reversible
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.