Registration Dossier
Registration Dossier
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EC number: 242-354-0 | CAS number: 18472-51-0
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- no
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:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hilltop Lab Animals, Scottsdale, PA, USA
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: no
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
- Number of animals per group: 5 m / 5 f
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- water
- Details on exposure:
- VEHICLE
- Concentration in vehicle: the 20% solution was diluted 1:4 with distilled water
- Amount applied: ca. 1 mL/min - Doses:
- not further specified
- No. of animals per sex per dose:
- 5 m / 5 f (total dosed: 35)
- Control animals:
- no
- Details on study design:
- -Duration of observation period following administration: 7 days
-Frequency of observations: at selected intervals after dosing on day 1 and daily for the remainder of the observation period
-Necropsy of survivors performed: no
-Other examinations performed: clinical signs and mortality - Statistics:
- according to Litchfield and Wilcoxon (1949)
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 24.2 mg/kg bw
- 95% CL:
- 21.8 - 26.9
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 25 mg/kg bw
- 95% CL:
- 21.5 - 29.8
- Mortality:
- Most mortalities occurred within 5 min after treatment.
- Clinical signs:
- Localized necrotic lesions at the site of injection.
- Body weight:
- no data
- Gross pathology:
- not done
Applicant's summary and conclusion
- Executive summary:
In this older study groups of 5 male and 5 female Wistar rats were dosed i.v. with chlorhexidine gluconate. The LD50 value for males and females was in a range of 24.2 - 25 mg/kg.
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