Chlorhexidine dihydrochloride

Endpoint summary

Description of key information

Oral toxicity:
No mortality or clinical signs was observed up to 5110 mg/kg bw. Due to no mortality, the LD50 value for male and female animals was estimated to be > 5000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Guideline is not stated in the study report. However, the method used is described in sufficient detail and follows the standard acute method in principal.

GLP compliance:

no

Remarks:

study performed prior to implementation of GLP

Test type:

standard acute method

Limit test:

yes

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: male: 72 d, female 83- 84 d
- Weight at study initiation: male: 206-224 g, female: 153 - 179 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

Route of administration:

oral: gavage

Vehicle:

other: suspension tragant (0.5%)

Details on oral exposure:

Application of 21.5 mL/kg (equal to 5110 mg/kg bw)

Doses:

5110 mg/kg bw

No. of animals per sex per dose:

m: 5
f: 5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not reported
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs

Statistics:

LD50: Probit analysis

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 110 mg/kg bw

Mortality:

No deaths recorded

Clinical signs:

other: No signs of intoxication were observed

Gross pathology:

not tested

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Under the conditions of this assay, chlorhexidine dihydrochloride was of very low oral toxicity to rats. The LD50 value for male and female animals was > 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 dihydrochloride. At the tested dose level (5110 mg/kg bw), no mortality or clinical signs was observed. Due to no mortality, the LD50 value for male and female animals was estimated to be > 5000 mg/kg bw. Under the conditions of the assay, chlorhexidine dihydrochloride was of very low oral toxicity to rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed