Registration Dossier
Registration Dossier
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EC number: 242-354-0 | CAS number: 18472-51-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The numbers of dose groups and the number of dead animals at each applied dose were not reported. This is considered a minor deficiency since a sufficient number of animals in total (50) and at least 5 animals/sex/group were used and the LD50 was calculated using a standard statistical method.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Remarks:
- GLP was not compulsory at the time the study was performed
- Test type:
- standard acute method
- Limit test:
- 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: ca. 16 h prior to dosing
- 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: at least 5 m / 5 f (total no.: 50)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20%tab
- Amount of vehicle (if gavage): no data
MAXIMUM DOSE VOLUME APPLIED: no data - Doses:
- not further specified
- No. of animals per sex per dose:
- at least 5 m / 5 f
- Control animals:
- no
- Details on study design:
- -Duration of observation period following administration: 14 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:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Based on:
- act. ingr.
- 95% CL:
- 1 597 - 2 504
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 270 mg/kg bw
- Based on:
- act. ingr.
- 95% CL:
- 1 796 - 2 869
- Mortality:
- All mortalities (in total 32/50) occurred within 6 days after treatment.
- Clinical signs:
- other: psychomotor depression, ataxia, depressed respiratory rate, sporadic incidences of ptosis, chromodacryorrhea, epistaxis and diarrhea
- Gross pathology:
- not done
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the conditions of this assay, chlorhexidine gluconate was of low toxicity to rats. The LD50 values for male and female animals were 2270 and 2000 mg/kg, respectively.
- Executive summary:
In this older study (method comparable to OECD guideline 401) groups of at least 5 male and 5 female Wistar rats were dosed orally via gavage with chlorhexidine gluconate. The LD50 values for male and female animals were 2270 and 2000 mg/kg bw, respectively. Clinical signs included psychomotor depression, ataxia, depressed respiratory rate, sporadic incidences of ptosis, chromodacryorrhoea, epistaxis and diarrhea.
Under the conditions of the assay, chlorhexidine gluconate was of low toxicity to rats.
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