Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 223-026-6 | CAS number: 3697-42-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- study performed prior to implementation of GLP
Test material
- Reference substance name:
- Chlorhexidine dihydrochloride
- EC Number:
- 223-026-6
- EC Name:
- Chlorhexidine dihydrochloride
- Cas Number:
- 3697-42-5
- Molecular formula:
- C22H30Cl2N10.2ClH
- IUPAC Name:
- chlorhexidine dihydrochloride
- Test material form:
- solid
- Details on test material:
- Chlorhexidindihydrochlorid
Chargen-Nr: 1/Dez. 83
CAS-Nr. 3967-42-5
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Source: ASTA-Werke AG, Bielefeld
-Age at study initiation: 5-6 months
-Weight at study initiation: 2 - 2.2 KG
-Housing: single in stainless steel cages
-Diet: Standard ssniff(R); no feed at treatment day
-Water: ad libitum
-Acclimation period: 1 day
ENVIRONMENTAL CONDITIONS
-Temperature (°C): 22 +/- 1
-Humidity (%): 50-60
-Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and scarified
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- Concentration: 0.5 g
- Duration of treatment / exposure:
- 4 hrs
- Observation period:
- up to 14 days after treatment
- Number of animals:
- 3
- Details on study design:
- TEST SITE
-Area of exposure: ca. 6.25 cm2
-% coverage: no data
-Type of wrap if used: occlusive
REMOVAL OF TEST SUBSTANCE
-Washing (if done): no data
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1-72 hrs
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: no effects observed
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- No edema or erythema noted. Scoring was 0 for each animal and time point of 1, 24, 48 and 72 hours after treatment. Primary score 0.0.
- Other effects:
- No systemic effects noted.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The treatment gave no indication for a dermal irritation potential of chlorhexidine dihydrochloride.
- Executive summary:
In this study according to OECD Guideline 404, 3 Albino rabbits were treated with 0.5 g of the test substance moistened with 0.9 mL of Aqua demin to one intact and one scarified test site, which was occluded for 4 hrs after treatment. Scoring was done according to Draize 1, 24, 48 and 72 hrs after application.
The treatment gave no indication for a dermal irritation potential and the PDII was calculated with 0.0.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
