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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:
5110 mg/kg: tremors, convulsions, prone position, disturbed startle reflexes, diarrhoea, laboured breathing
Body weight:
no data
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.