Registration Dossier

Diss Factsheets

Administrative data

Description of key information

The acute toxicity of chlorhexidine was tested for the oral and dermal route and in both cases the acute toxicity was low.
For the inhalatory route there are no studies available. However, due to the physico-chemical properties of the substance, exposure via inhalation is unlikely. Therefore, testing for acute inhalation toxicity is scientifically not justified.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 815 mg/kg bw

Additional information

Acute oral toxicity

The acute oral toxicity of chlorhexidine was tested in a study (method comparable to OECD guideline 401; no GLP) with groups of at least 5 male and 5 female Wistar rats. The LD50 values for male and female animals were approximately 5000 mg/kg bw. Clinical signs included psychomotor depression, ataxia, depressed respiratory rate, sporadic incidences of ptosis, chromodacryorrhoea, epistaxis and diarrhea.

In several other studies with rats and mice comparable or even higher LD50 values were obtained.

Acute dermal toxicity

The acute dermal toxicity chlorhexidine (administered as chlorhexidine digluconate) was tested in a study (method according to US EPA Proposed Guideline for Toxicology – Section 162.81-2) with 2 male and 2 female rabbits dosed with 5000 mg/kg bw. Under the conditions of the assay, 2815 mg/kg bw of chlorhexidine base caused no deaths. Moderate to severe skin irritation was observed that subsided in most animals within one week but led to epidermal scrubbing in one animal.

Acute inhalation toxicity

There are no studies available performed with chlorhexidine gluconate. Due to the physico-chemical properties of the substance, exposure via inhalation is unlikely. Therefore, testing for acute inhalation toxicity is scientifically not justified.

Justification for classification or non-classification

For both routes (oral and dermal) the acute toxicity of chlorhexidine when administered as chlorhexidine digluconate is low.

Categories Display