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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
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

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
Chemical structure
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
Molecular formula:
C22H30Cl2N10.2C6H12O7
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
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 levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
none
Clinical signs:
other: 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 ver
Gross pathology:
No significant findings on the interior side of the skin; all organs unremarkable

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
LD50 >5000 mg/kg
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, 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.