Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records

Reference

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)

Rationale for reliability incl. deficiencies:

other: The study is conducted according to the current guideline and in accordance with GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)

GLP compliance:

yes (incl. QA statement)

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
relative humidity 30-70%
12-hour light/12 hour dark cycle.

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 prescence of spermatozoa in veginal 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
nonpregnant 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

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

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 atrophic changes in prostate gland.

Remarks on result:

other: Generation: No data (migrated information)

Reproductive effects observed:

not specified

Conclusions:

The test substance pigment yellow 191 was evaluted in reproduction/developmental screening test. The NOAEL based on the study results was concluded to be 1000 mg/kg bw/day (rat;male/female).

Executive summary:

In the dose-range finding experiment with the test substance changes of body weight gain were not observed in treated males and females. No treatment related adverse effects on animal health or behavior of animals were observed at any dose level. Results of haematological examination showed changes in white blood cells in females at the dose levels 500 and 1000 mg/kg/day. Pathological examination revealed only changes related to colour of the test substance at the dose levels 500 and 1000 mg/kg/day. No animal died during the 14-day application period.

The study was conducted according to OECD guideline 421 and in compliance of GLP.

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

Reproduction/Developmental Toxicity Screening Test (OECD Guideline 421) was performed to obtain information about test substance related adverse effects on fertility of parental animals or possible adverse effects on development of pups. The test was performed in accordance with GLP.

In the dose-range finding experiment no body weight changes were observed in treated males and females when compared to untreated controls. Health condition control and clinical observation did not detect adverse impact on clinical status and behaviour of animals at any dose level. Results of haematological examination showed the test substance influenced on white blood cells in females at 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.

The influence of the test substance treatment was observed mainly at the highest dose level (limit dose) – decrease of absolute and relative weight of prostate gland and occurrence of atrophic changes in prostate gland of parental males. The changes relating to prostate gland at the dose level 1000 mg/kg were considered of effect related to the test substance (without negative influence on fertility of parental males). 

Reproductive performance – ability of male and female animals to successfully mate and produce viable offspring was unaffected by the test substance treatment. Also development of pups was not changed in treatment groups.

Short description of key information:
For the test substance, following values of reproduction toxicity were found:
The NOEL (No Observed Effect Level) for the toxic effect on reproduction organs of males was established as 400 mg/kg body weight/day (the value is based on the incidence of atrophic changes in prostate gland).
The NOEL (No Observed Effect Level) for the toxic effect on reproduction organs of females was established as 1000 mg/kg body weight/day.
The NOAEL (No Observed Adverse Effect Level) for REPRODUCTION was established as 1000 mg/kg body weight/day.

Justification for selection of Effect on fertility via oral route:
The reliable guideline compliant study.

Effects on developmental toxicity

Description of key information

The NOAEL (No Observed Adverse Effect Level) for development of pups was established as 1000 mg/kg body weight/day.

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Additional information

Reproduction/Developmental Toxicity Screening Test (OECD Guideline 421) was performed to obtain information about test substance related adverse effects on fertility of parental animals or possible adverse effects on development of pups. The test was performed in accordance with GLP.

In the dose-range finding experiment no body weight changes were observed in treated males and females when compared to untreated controls. Health condition control and clinical observation did not detect adverse impact on clinical status and behaviour of animals at any dose level. Results of haematological examination showed the test substance influenced on white blood cells in females at 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.

The influence of the test substance treatment was observed mainly at the highest dose level (limit dose) – decrease of absolute and relative weight of prostate gland and occurrence of atrophic changes in prostate gland of parental males. The changes relating to prostate gland at the dose level 1000 mg/kg were considered of effect related to the test substance (without negative influence on fertility of parental males). 

Reproductive performance – ability of male and female animals to successfully mate and produce viable offspring was unaffected by the test substance treatment. Also development of pups was not changed in treatment groups.

Justification for selection of Effect on developmental toxicity: via oral route:
The reliable guideline compliant study

Justification for classification or non-classification

No reproduction or developmental toxicity was observed at the highest tested dose level (1000 mg/kg bw/day) and therefore no classification required according to the CLP Regulation (EC) 1272/2008 and EU Directive 67/548/EEC.