Registration Dossier
Registration Dossier
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EC number: 200-238-7 | CAS number: 55-56-1
Endpoint summary
Administrative data
Description of key information
Concerning skin and eye irritation several studies with chlorhexidine administered as base or as chlorhexidine digluconate have been performed in experimental animals.
Chlorhexidine base did not cause skin irritation in a guideline study in rabbits. Therefore, classification and labelling of chlorhexidine gluconate with respect to dermal irritation is not needed.
A 20 % chlorhexidine digluconate solution is considered to cause severe eye irritation.
Due to the physico-chemical properties of chlorhexidine base inhalation is very unlikely and therefore testing on respiratory irritation is considered to be not necessary.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin irritation
The results of skin irritation studies with chlorhexidine (administered as chlorhexidine digluconate) are summarised in the following Table.
In a study according to OECD guideline 404 with solid (100 %) chlorhexidine digluconate provided evidence of no skin irritation in rabbits. Similarly, 5 % and 4 % chlorhexidine digluconate solutions were not irritating in further studies comparable to OECD guideline 404.
Species |
Method |
Concentration of test substance |
Average score 24, 48, 72 h
|
Reversibility |
Result |
|
Rabbit |
OECD guideline 404 |
Solidchlorhexidine digluconate |
24, 48, 72 h: Erythema: 1.0 |
24, 48, 72 h Edema: 0 |
Yes |
Not irritating |
Rabbit |
Comparable to OECD guideline 404 |
5 % solution ('Hibitane') |
Combined average 24 + 72 h score*: 0.583 |
Yes |
Not irritating |
|
Rabbit |
Comparable to OECD guideline 404 |
4 % solution ('Hibiscrub') |
Combined average 24 + 72 h score*: 0.75 |
Yes |
Not irritating |
|
*: for erythema + edema on intact and on abraded skin.
Eye irritation
The results of eye irritation studies with chlorhexidine (administered as chlorhexidine digluconate) in animals are summarised in the following Table.
A 20 % chlorhexidine digluconate solution caused a severe irritation reaction in rabbit eyes in a Draize test. A 5 % chlorhexidine digluconate containing formulation ('Hibitane') caused eye irritation in rabbits, whereas another 4 % formulation was only mildly irritating.
Eye irritation of chlorhexidine digluconate
Species |
Method |
Concentration of test substance |
Average Score |
Result |
Reversibility |
||
Cornea |
Iris |
Redness and chemosis Conjunctiva |
|||||
Rabbit |
Draize |
20 % solution |
Total score: > 85 of 110 |
Irritating |
No |
||
Rabbit |
Draize, study comparable to OECD guideline 405 |
5 % solution ('Hibitane') |
11.25 |
3.4 |
8.43 |
Irritating |
Yes |
Rabbit |
Draize, study comparable to OECD guideline 405 |
4 % solution ('Hibiscrub') |
0 |
0 |
4.93 |
Irritating |
Yes |
Effects on eye irritation: highly irritating
Justification for classification or non-classification
Conclusion on skin irritation
Chlorhexidine when administered as chlorhexidine digluconate did not cause skin irritation in a guideline study in rabbits. Therefore, classification and labelling of chlorhexidine with respect to dermal irritation is not needed.
Conclusion on eye irritation
A 20 % chlorhexidine digluconate solution is considered to cause severe eye irritation.
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