Propanoic acid, 2-hydroxy-, compd. with 7-[[4,6-bis[[3-(diethylamino)propyl]amino]-1,3,5-triazin-2-yl]amino]-3-[2-(2,3-dihydro-2-oxo-1H-benzimidazol-6-yl)diazenyl]-4-hydroxy-2-naphthalenesulfonic acid (1:1)

Toxicity to reproduction

Administrative data

Endpoint:

screening for reproductive / developmental toxicity

Remarks:

based on test type (migrated information)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

registered substance

IUPAC Name:

registered substance

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Milli-Q-Water

Details on mating procedure:

the females were housed individually when daily vaginal smear was sperm positive or a copulation plug was observed;

Details on analytical verification of doses or concentrations:

the dose formulations were prepared weekly;

Duration of treatment / exposure:

males treated for 28 days; dams and pups on day 4 post partum; if birth did not occur the dam was sacrified on day 25 post coitum;

Frequency of treatment:

once daily

Doses / concentrations

Remarks:

Doses / Concentrations:
10 ml/kg b.w.
Basis:
actual ingested

No. of animals per sex per dose:

40 males, 10 per group;
40 females, 10 per group

Examinations

Parental animals: Observations and examinations:

Viability/ Mortality: twice daily; clinical signs; food consumption; body weights;

Litter observations:

litter size, live birth, still birth and gross anomalies; sex ratio; body weights;

Postmortem examinations (parental animals):

males were sacrified after 28 days treatment: damps and pups were sacrified on day 4 post partum; all parent animals and pups were examined macroscopically; for the parent animals, special attention was directed at the organs of the reproductive system.

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

Other effects:

no effects observed

Effect levels (P0)

1

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: based on the discoloration of feces;

2

Dose descriptor:

NOEL

Effect level:

1 000 mg/kg bw/day

Based on:

test mat.

Sex:

male/female

Results: F1 generation

General toxicity (F1)

Mortality / viability:

no mortality observed

Description (incidence and severity):

during the first 4 days post partum

Body weight and weight changes:

no effects observed

Description (incidence and severity):

during the first 4 days post partum

Details on results (F1)

no findings during macroscopic examination

Overall reproductive toxicity

Reproductive effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

A valid screening study for reprotoxicity (OECD 421) with the stubstance registered is avaliable. All animals survived the scheduled study period. No indices of a general toxicity were observed during the entire study at any dose level. The reproduction and developmental parameters investigated within this study did not give any indication of any test item-related effect. Thus, the NOAEL for general toxicity was determined to be 1000 mg/kg/day , also is the NOAEL for developmental toxicity considered to be 1000mg/kg/day.