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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate
EC Number:
403-530-4
EC Name:
Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate
Cas Number:
129423-54-7
Molecular formula:
C17H15ClN4O7S2.Ca
IUPAC Name:
calcium 4-chloro-5-methyl-2-{2-[3-methyl-5-oxo-1-(3-sulfonatophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazen-1-yl}benzene-1-sulfonate

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Rats of SPF quality.
15 air changes per hour
temperature 19 - 25 °C
relative humidity 30-70%
12-hour light/12-hour dark cycle

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Details on mating procedure:
Animals were mated from the 15th day of study. Each morning the females were examined for presence of spermatozoa in vaginal smears. Day 0 of pregnancy was defined as the day the sperms were found.
Duration of treatment / exposure:
both sex - 14 days prior to the mating period +
males - 14 days during and after the mating period (totally for 28 days)
pregnant females - during pregnancy and till 3rd day of lactation
nonpregnat females - for 25 days after the confirmed mating
14 days prior to the mating period
14 days during the mating period
Frequency of treatment:
Daily
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
160 mg/kg of body weight/day
Basis:

Remarks:
Doses / Concentrations:
400 mg/kg of body weight/day
Basis:

Remarks:
Doses / Concentrations:
1000 mg/kg of body weight/day
Basis:

No. of animals per sex per dose:
12 males and 12 females
3 doses+1 control group (48 males+48 females completely)
Control animals:
yes

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Sex:
male/female
Basis for effect level:
other: The value is based on the incidence of atropic changes in prostate gland.
Remarks on result:
other: Generation: no data (migrated information)

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
In the dose-range finding experiment with the test substance changes of body weight increments were not observed in treated males and females.
Health condition control and clinical observation did not detect adverse impact of the test substance on the health condition, clinical status and behavior of animals at all dose levels.
Results of haematological examination showed the test substance influence on white blood component in females of the dose levels 500 and 1000 mg/kg/day.
Pathological examination revealed only changes related to colour of the test - at the dose levels 500 and 1000 mg/kg/day.
No animal died during the 14-day application period.