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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984-07-17 to 1984-08-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Chlorhexidine
EC Number:
200-238-7
EC Name:
Chlorhexidine
Cas Number:
55-56-1
Molecular formula:
C22H30Cl2N10
IUPAC Name:
N',N'''''-hexane-1,6-diylbis[N-(4-chlorophenyl)(imidodicarbonimidic diamide)]

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 51 - 65 d
- Weight at study initiation: 136 - 176 g
- Fasting period before study: ca. 16 h prior to dosing
- Housing: Single in Macrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 d
- Number of animals per group: 5

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 50 - 60
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Application of 2 * 21.1 mL/kg within 4 h (equal to 5110 mg/kg bw)
In addition 3 females were dosed with 1000 and 2150 mg/kg bw, resp.
Doses:
m: 5110 mg/kg bw
f: 1000, 2150 and 5110mg/kg bw
No. of animals per sex per dose:
m: 5
f: 1, 2 and 5
Control animals:
no
Details on study design:
-Duration of observation period following administration: 14 days
-Necropsy performed: yes
-Other examinations performed: clinical signs and mortality
Statistics:
not done

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 5 000 mg/kg bw
Mortality:
m: 2/5 within 3 d
f: 3/5 at 5110 mg/kg within 4 d
Clinical signs:
other: 5110 mg/kg: tremors, convulsions, prone position, disturbed startle reflexes, diarrhoea, laboured breathing
Gross pathology:
tympania (stomach) in died animals

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the conditions of this assay, chlorhexidine was of low toxicity to rats. The LD50 value for male and female animals was ca. 5000 mg/kg bw
Executive summary:

In this study performed according to OECD guideline 401, groups of 5 male and 5 female Wistar rats were dosed orally via gavage with chlorhexidine. At the highest dose level (5110 mg/kg bw), clinical signs included tremors, convulsions, prone position, disturbed startle reflexes, diarrhoea, and laboured breathing. Due to the mortality of 3/5 females, the LD50 value for male and female animals was estimated to be in the range of 5000 mg/kg bw.

Under the conditions of the assay, chlorhexidine was of low toxicity to rats.