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Toxicological information

Toxicity to reproduction

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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:
2004

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
No data
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
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

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)

No treatment related effects were observed in the parental rats or the pups up to 500 mg/kg.

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.