Registration Dossier
Registration Dossier
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EC number: 242-354-0 | CAS number: 18472-51-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-01-17 to 2002-03-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)
- EC Number:
- 242-354-0
- EC Name:
- D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)
- Cas Number:
- 18472-51-0
- Molecular formula:
- C22H30Cl2N10.2C6H12O7
- IUPAC Name:
- N',N'''''-hexane-1,6-diylbis[N-(4-chlorophenyl)(imidodicarbonimidic diamide)] - D-gluconic acid (1:2)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Source: LPT, Hamburg
-Age at study initiation: ca. 5.5 months
-Weight at study initiation: 2.4 - 2.5 kg
-Housing: single
-Diet: ad libitum before and after exposure
-Water: ad libitum before and after exposure
ENVIRONMENTAL CONDITIONS
-Temperature (°C): 20 +/- 3
-Humidity (%): 55 +/- 15
-Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 500 mg/animal
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- up to 12 days after exposure
- Number of animals:
- 3
- Details on study design:
- TEST SITE: Dorsal area of the trunk (6 cm2)
REMOVAL OF TEST SUBSTANCE: No residual test substance had to be removed after 4 hours
SCORING SYSTEM: As described in OECD Guideline 404
CONTROL: Surrounding untreated skin
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1-3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 1-3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- There were no systemic intolerance reactions.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the assay, rabbits exposed to chlorhexidine digluconate under semi-occlusive conditions for 4 hours showed only very slight (grade 1) and reversible erythema. Therefore, the substance can be classified as non irritating.
- Executive summary:
Chlorhexidine digluconate was tested in an acute skin irritation test (patch test) in rabbits according to OECD guideline 404. There were only very slight (grade 1) and reversible erythema. Therefore, the substance can be classified as non skin irritating.
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