Registration Dossier
Registration Dossier
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EC number: 211-199-0 | CAS number: 633-96-5
Toxicity to reproduction
Administrative data
- Endpoint:
- three-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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:
- publication
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- No data
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate
- EC Number:
- 220-491-7
- EC Name:
- Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate
- Cas Number:
- 2783-94-0
- Molecular formula:
- C16H12N2O7S2.2Na
- IUPAC Name:
- Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
5 mg/kg
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
50 mg/kg
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
150 mg/kg
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
500 mg/kg
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10 males and 20 females
- Control animals:
- yes, concurrent no treatment
Examinations
- Parental animals: Observations and examinations:
- No treatment related effects were observed in the parental rats or the pups up to 500 mg/kg.
- Oestrous cyclicity (parental animals):
- No treatment related effects were observed in the parental rats or the pups up to 500 mg/kg.
- Sperm parameters (parental animals):
- No treatment related effects were observed in the parental rats or the pups up to 500 mg/kg.
- Litter observations:
- No treatment related effects were observed in the parental rats or the pups up to 500 mg/kg.
- Postmortem examinations (parental animals):
- No treatment related effects were observed in the parental rats or the pups up to 500 mg/kg.
- Postmortem examinations (offspring):
- No treatment related effects were observed in the parental rats or the pups up to 500 mg/kg.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
Results: F1 generation
Effect levels (F1)
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No treatment related effects were observed in the parental rats or the pups up to 500 mg/kg. The tested substance does not cause any adverse effect and it could be concluded that teh susbtance does not show any toxicity for reproduction.
- Executive summary:
No treatment related effects were observed in the parental rats or the pups up to 500 mg/kg. The tested substance does not cause any adverse effect and it could be concluded that teh susbtance does not show any toxicity for reproduction. The NOAEL value is 500 mg/kg.
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