Registration Dossier
Registration Dossier
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EC number: 202-208-9 | CAS number: 93-00-5
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from the SCCP report.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- OPINION ON PHENYLBENZIMIDAZOLE SULFONIC ACID AND ITS SALTS
- Author:
- HEALTH AND CONSUMER PROTECTION DIRECTORATE GENERAL
- Year:
- 2 006
- Bibliographic source:
- OPINION ON PHENYLBENZIMIDAZOLE SULFONIC ACID AND ITS SALTS- SCCP/1056/06
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- The present study was conducted to determine the reproductive toxicity potential of test chemical when administered orally to rats.
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data available
Test material
- Reference substance name:
- Ensulizole
- IUPAC Name:
- Ensulizole
- Reference substance name:
- 2-phenyl-1H-benzimidazole-5-sulphonic acid
- EC Number:
- 248-502-0
- EC Name:
- 2-phenyl-1H-benzimidazole-5-sulphonic acid
- Cas Number:
- 27503-81-7
- Molecular formula:
- C13H10N2O3S
- IUPAC Name:
- 2-phenyl-1H-benzimidazole-5-sulfonic acid
- Test material form:
- solid
- Details on test material:
- - IUPAC name:Phenylbenzimidazole Sulfonic Acid
- Molecular formula: C13H10N2O3S
- Molecular weight: 274.299g/mol
- Substance type: organic
-Physical state: solid
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Wistar BOR:Wisw (SPFcpb)
- Details on species / strain selection:
- No data available
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Virgin females were used in the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- (distilled water)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: No data available
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): No data available
- Concentration in vehicle: 1000 mg/kg bw by
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- day 6 to 15 post coitum
- Frequency of treatment:
- 5ml daily
- Details on study schedule:
- No data available
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 other: mg/kg bw
- Remarks:
- Control group
- Dose / conc.:
- 1 000 other: mg/kg bw
- Remarks:
- Test group
- No. of animals per sex per dose:
- Total:50
0 mg/kg bw (control group): 25 female rats
1000 mg/kg bw (test group): 25 female rats - Control animals:
- yes
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: No data
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data
BODY WEIGHT: No data
- Time schedule for examinations: No data
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study):No data
- Time schedule for examinations: No data
OTHER: Following reproductive parameters were examined:
Corpora lutea
Implantations
Resorptions (complete, early and late) - Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- No data available
- Postmortem examinations (parental animals):
- Animals were sacrificed on day 20 and necropsied.
GROSS NECROPSY: Yes
HISTOPATHOLOGY / ORGAN WEIGHTS: Yes - Postmortem examinations (offspring):
- No data available
- Statistics:
- No data available
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- There were no signs of toxicity in dams.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No effect was observed on numbers of corpora lutea, implantation sites, and viable fetuses were found.
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 other: mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical signs
- other: No effects was observed on reproductive parameter tested.
- Remarks on result:
- other: No effect was observed on numbers of corpora lutea, implantation sites, and viable fetuses were found.
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Did not show any such malformations.
- Histopathological findings:
- no effects observed
- Description (incidence and severity):
- Skeletal variations were the same (nature and frequency) in test- and control group.
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Details on results (F1)
the same (nature and frequency) in test- and control group.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 other: mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects observed on foetuses.
- Remarks on result:
- other: No developmental toxicity was observed
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
Any other information on results incl. tables
Parameters |
Control |
Test |
||||||
Total |
Mean |
Total |
mean |
|||||
Animals |
|
|
litter |
% |
|
Litter |
% |
|
Total |
25 |
- |
- |
25 |
- |
- |
||
pregnant |
23 |
- |
- |
24 |
- |
- |
||
Corpora lutea |
279 |
12.1 |
- |
269 |
11.2 |
- |
||
Implantations |
260 |
11.0 |
- |
233 |
9.7 |
- |
||
Resorptions |
Complete |
0 |
0 |
0* |
1 |
0.04 |
0.3* |
|
Early |
6 |
0.26 |
2.5* |
5 |
0.21 |
1.9* |
||
Late |
3 |
0.13 |
1.2* |
3 |
0.13 |
1.2* |
||
Foetuses |
Dead |
0 |
0 |
0* |
0 |
0 |
0* |
|
Live |
251 |
10.9 |
96.3* |
224 |
9.3 |
96.6* |
||
Male |
128 |
5.6 |
50.3** |
132 |
5.5 |
58.4** |
||
Female |
123 |
5.3 |
49.7** |
92 |
3.8 |
41.6** |
||
*) relative to number of implantations (avg. of individual dams)
**) relative to number of live foetuses (avg. of individual dams)
Applicant's summary and conclusion
- Conclusions:
- Under the condition of this study, the no-observed-adverse-effect level (NOAEL) for dams and foetuses was considered to be 1000 mg/kg bw.
- Executive summary:
The present study was conducted to determine the reproductive toxicity potential of test chemical.when administered orally to rats. Virgin female rats were used for the study. Two dose groups (25 animals each) were used, one test- (1000 mg/kg bw) and one control group (0 mg/kg bw). They were dosed from day 6-15 post coitum and kept off-dose from day 16-19. There were no signs of toxicity in dams. Animals were sacrificed on day 20 and necropsied. Reproductive parameters were examined [viz.no. of corpora lutea, no. of implantations and resorptions (complete, early and late)]. Foetuses were weighed, inspected macroscopically for external malformations and prepared for inspection for visceral and skeletal malformations (by transverse section and double staining respectively). They did not show any such malformations. Skeletal variations were the same (nature and frequency) in test- and control group. No effect was observed on numbers of corpora lutea, implantation sites, and viable fetuses were found.
Therefore, under the condition of this study, the no-observed-adverse-effect level (NOAEL) for dams and foetuses was considered to be 1000 mg/kg bw.
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