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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study performed according to US EPA Proposed Guideline for Toxicology - Section 162.81-2, but only a summary of the full study is available. Due to the very high structural similarity between chlorhexidine base and chlorhexidine gluconate, the data generated for this endpoint using chlorhexidine gluconate are considered to be relevant for chlorhexidine base after dose level correction.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EPA - Proposed Guidelines for Toxicology - Section 162.81-2 and 5
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes

Test material

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:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
no further data

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
application to abraded skin (no further data)
Duration of exposure:
no data
Doses:
5 g/kg bw as chlorhexidine gluconate and 2.82 g/kg bw as chlorhexidine base
No. of animals per sex per dose:
2 m / 2 f
Control animals:
no
Details on study design:
post-observation period: 14 d
Statistics:
no data

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 815 mg/kg bw
Based on:
other: chlorhexidine base
Mortality:
none
Clinical signs:
All rabbits were exceedingly hyperaemic at the end of 24 hrs. Moderate to severe (2 animals) or severe (2 animals) skin irritation into eschar formation. Skin thickening. Irritation subsided in 3 animals within one week, but in one animal, skin became very dry and thickened and epidermis could be stripped off the dermis.
Body weight:
no data
Gross pathology:
No significant findings on the interior side of the skin; all organs unremarkable

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
Under the conditions of the assay, chlorhexidine gluconate showed a very low acute dermal toxicity.
Executive summary:

Acute dermal toxicity study in rabbits according to EPA guideline.

Under the conditions of the assay, 2815 mg/kg of chlorhexidiene base (5000 mg/kg of chlorhexidine gluconate) caused no death in rabbits. Moderate to severe skin irritation was observed that subsided in most animals within one week but led to epidermal scrubbing in one animal.

Overall, the test substance was irritating to the skin but the acute dermal toxicity of the test substance was low.