Registration Dossier
Registration Dossier
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EC number: 200-238-7 | CAS number: 55-56-1
Specific investigations: other studies
Administrative data
- Endpoint:
- cytotoxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment. This study was performed for developing an alternative in vitro test system for the detection of an eye irritating potential.
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicity monitored with a correlated set of cell-culture assays
- Author:
- Borenfreund E & Shopsis C
- Year:
- 1 985
- Bibliographic source:
- Xenobiotica 15, 705-711
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- One test was an assessment of the highest concentration of the test substance, which caused minimal morphological alterations in cell cultures (3T3 and HepG2 cells), followed by a determination of the amount of neutral red dye uptake by the cells.
In a second test a 50 % inhibition of uptake of [3H]uridine after incubation of the cell cultures (3T3 and WI-38 cells) was determined. - GLP compliance:
- no
- Type of method:
- in vitro
Test material
- 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)]
- Details on test material:
- -Name of test material (as cited in study report): Chlorhexidine
Constituent 1
Test animals
- Species:
- other: in vitro
Results and discussion
Any other information on results incl. tables
HTD (ug/mL) at 24 hrs |
UI 50 (ug/mL) at 4 hrs |
||
3T3 |
Hep G2 |
WI-38 |
3T3 |
0.5 |
1.0 |
0.3 |
3 |
HTD: highest tolerated dose; UI 50: concentration inducing 50 % inhibition in the uptake of [3H]uridine
Applicant's summary and conclusion
- Executive summary:
This study was performed for developing an alternative in vitro test system for the detection of an eye irritating potential. The authors concluded that these in vitro results showed a good correlation with the in vivo data from Draize rabbit eye irritancy tests.
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.
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