Pigment Yellow FC 26290

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)

Principles of method if other than guideline:

A reproduction/developmental toxicity screening test in rats to assess general toxicity and potential effects on fertility of the F0 generation as well as potential effects on pre- and early postnatal development of the F1 generation after oral exposure was conducted in compliance with the OECD Guideline for Testing of Chemicals, Section 4: Health Effects No. 421 „Reproduction/Developmental Toxicity Screening Test“, adopted July 27, 1995

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

Test Item: Bayplast Gelb G Gran
Synonymes: Pigment Yellow FC 26290
Chemical name: 2-[[5-amino-3-methyl-1-(3-sulfophenyl)- 1H-pyrazol-4-yl]azo]-4,5-dichloro-benzenesulfonic acid, calcium salt 1:1
CAS No.: 111071-53-5
Molecular Mass (g/mol): 544.4 g/mol
Content(s): 86.4%

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

physiological saline

Details on mating procedure:

The F0 animals were pretreated with the test substance for 2 weeks prior to the cohabitation period. During the following cohabitation period the first F0 male was co-housed with the first female F0 animal within the group and so on over night (afternoon up to next morning) at a planned maximum of 14 times during the two-week cohabitation period. As a rule inseminated females were not further co-housed. Insemination was established by investigating vaginal smears prepared in the morning after co-housing or by occurrence of a vaginal plug.

Analytical verification of doses or concentrations:

yes

Frequency of treatment:

The test substance or vehicle was administered daily to the animals from the first day of the study until the day before scheduled necropsy.

Details on study schedule:

males: 36 days
females: 57 days

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 100, 300 or 1000 mg/kg body weight
Basis:
nominal conc.

No. of animals per sex per dose:

12 male and 12 female Wistar rats per dose group

Control animals:

yes, concurrent vehicle

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:

NOEL

Effect level:

1 000 mg/kg bw/day

Based on:

test mat.

Sex:

male/female

Results: F1 generation

Effect levels (F1)

Dose descriptor:

NOEL

Generation:

F1

Effect level:

1 000 mg/kg bw/day

Based on:

act. ingr.

Sex:

male/female

Overall reproductive toxicity

Reproductive effects observed:

not specified

Any other information on results incl. tables

The compound did not result in any signs of parental toxicity. The yellow discoloration of the content of the gastro-intestinal tract was a consequence of the administration of the strongly coloured test compound. Body weight and food consumption were not affected. Reproduction parameters did not indicate any effect on male or female reproductive function. In addition, no effects on developmental parameters in F0 females and on parameters measured in F1 pups were found indicating any signs of developmental toxicity.

Applicant's summary and conclusion

Executive summary:

Bayplast Gelb G Gran (Pigment Yellow FC 26290_CAS no 111071-53-5)was administered daily via gavage in 0.9% aqueous sodium chloride solution to 12 male and 12 female Wistar rats per dose group, in doses of 0, 100, 300 or 1000 mg/kg body weight. Treatment started 2 weeks prior to mating and continued during the mating period of up to 2 weeks. Males were dosed further up to necropsy for a total period of at least 4 weeks and females were dosed during gestation and lactation up to their necropsy on day 4-6 post partum.

Investigations were performed on general tolerance of the test compound by the parental animals as well as on effects on reproduction including early postnatal development of F1 pups. The animals were regularly observed and weighed, food intake and reproduction parameters were determined. Selected organs were weighed and organs were subjected to macroscopical and histopathological investigations.

The compound did not result in any signs of parental toxicity. The yellow discoloration of the content of the gastro-intestinal tract was a consequence of the administration of the strongly coloured test compound. Body weight and food consumption were not affected. Reproduction parameters did not indicate any effect on male or female reproductive function. In addition, no effects on developmental parameters in F0 females and on parameters measured in F1 pups were found indicating any signs of developmental toxicity.

In conclusion, 1000 mg/kg represents the NOEL for male and female reproductive function and for developmental toxicity.