Pigment Yellow FC 26290

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)

Principles of method if other than guideline:

Five male and female rats each received Pigment Yellow FC 26290 in daily dosages of 0 (vehicle control), 40, 200 and 1000 mg/kg body weight for 28 days. In addition, 5 male and female rats per group were treated with physiological saline solution (vehicle) or 1000 mg/kg and observed for another 2 weeks

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

content: 83.9% (free acid)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

physiological saline

Analytical verification of doses or concentrations:

yes

Duration of treatment / exposure:

28 days

Frequency of treatment:

The test compound was administered by gavage once a day, 7 days per week, 28 times in total

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 40, 200, 1000 mg/kg bw/d
Basis:

No. of animals per sex per dose:

5 males and 5 females/dose

Control animals:

yes, concurrent vehicle

Results and discussion

Effect levels

Dose descriptor:

NOAEL

Effect level:

1 000

Based on:

test mat.

Sex:

male/female

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

Appearance and general behaviour were not influeneed by treatment up to and including 1000 mg/kg. The general condition was

temporarily reduced in some animals of the dose group 1000 mg/kg. Growth, mortality, feed and water intake were not affected by

treatment.

Hematological and histopathological investigations gave no indication of toxicologically relevant damage to blood or hematopoietic organs up to and including 1000 mg/kg. Neither clinico-chemical nor gross pathological or histopathological investigations produced any evidence of treatment-related metabolic or organ damage.

Applicant's summary and conclusion

Executive summary:

Five male and female rats each received Pigment Yellow FC 26290 in daily dosages of 0 (vehicle control), 40, 200 and 1000 mg/kg body weight for 28 days. In addition, 5 male and female rats per group were treated with physiological saline solution (vehicle) or 1000 mg/kg and observed for another 2 weeks.

The animals were regularly observed, weighed, and their feed and water intakes were determined. In week 4 and 6 (recovery groups) urine and blood samples were collected and various parameters determined. At necropsies organs were weighed and gross pathological investigations performed. A number of organs and tissues were processed histopathologically.

Appearance and general behaviour were not influeneed by treatment up to and including 1000 mg/kg. The general condition was

temporarily reduced in some animals of the dose group 1000 mg/kg. Growth, mortality, feed and water intake were not affected by

treatment.

Hematological and histopathological investigations gave no indication of toxicologically relevant damage to blood or hematopoietic organs up to and including 1000 mg/kg. Neither clinico-chemical nor gross pathological or histopathological investigations produced any evidence of treatment-related metabolic or organ damage.

Under the conditions described the NOAEL for Pigment Yellow FC 26290 is 1000 mg/kg bw/day.