Caramel (color)

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: not specified

Principles of method if other than guideline:

Virgin adult female alboino CD-1 outbred mice were gang-housed in disposable plastic cages in temperature and humidty-controlled quarters wit free access to food and fresh tap water. They were mated with young adult males, and observation of the vaginal sperm plug was considered Day 0 of gestation. Beginning on Day 6 and continuing daily through Day 15 of gestation, the females were dosed with the indicated dosages by oral intubation ; the controls were sham treated.

Body weights were recorded on Days 0, 6, 11, 15 and 17 of gestation. All animals were observed daily for appearance and behaviour with particular attention to food consumption and weight, in order to rule out any abnormalities which may have occurred as a result of anorexic effects in the pregnant female animal.

On Day 17 all dams were subjected to Caesarean section under surgical anesthesia, and the numbers of implantation sites, resorption sites, and live and dead fetuses were recorded. The body weights of the live pups were also recorded. The urogenital tract of each dam was examined in detail for anatomical normality.

All fetuses were examined grossly for the presence of external congeniital abnormalities. One-third of the fetuses of each litter underwent detailed visceral examinations employing the Wilson tecnique. The remaining two-thrids were cleared in potassium hydroxide (KOH), stained with alizarin red S dye and examined for skeletal defects.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Caramel (color)

EC Number:

232-435-9

EC Name:

Caramel (color)

Cas Number:

8028-89-5

Molecular formula:

C6H12OH

IUPAC Name:

Caramel

Test animals

Species:

mouse

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Key result

Dose descriptor:

NOAEL

Effect level:

>= 1 600 mg/kg bw/day (nominal)

Basis for effect level:

dead fetuses

mortality

Results (fetuses)

Effect levels (fetuses)

Key result

Dose descriptor:

NOAEL

Effect level:

>= 1 600 mg/kg bw/day (nominal)

Basis for effect level:

other: fetus survival

Overall developmental toxicity

Key result

Developmental effects observed:

no