Calcium bis[2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate]

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well described, comparable with OECD 414, brief data on animals, environmental conditions and diet preparation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

GLP compliance:

no

Remarks:

pre-GLP study

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate]

EC Number:

225-935-3

EC Name:

Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate]

Cas Number:

5160-02-1

Molecular formula:

C17H13ClN2O4S.1/2Ba

IUPAC Name:

Barium bis{5-chloro-2-[(2-hydroxy-1-naphthyl)diazenyl]-4-methylbenzenesulfonate}

Test material form:

solid: nanoform

Details on test material:

received from the Sun Chemical Corporation, 06/12/1972
light red powder
"D&C Red #9 BA LAKE, Brilliant Red C15-019"
Lot. No Y2314

Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.

Test animals

Species:

rat

Strain:

other: Charles River CD rats

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Charles River
- Housing: individually after mating
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
in a temperature and humidity controlled room

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5 % methocel

Details on exposure:

PREPARATION OF DOSING SOLUTIONS:

DIET PREPARATION
suspended in 0.5% Methocel
constant administration of 1 ml/100 g bw

VEHICLE
Dow's Methocel 90 HG Premium l5,000 CPS

Analytical verification of doses or concentrations:

not specified

Details on mating procedure:

- Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 2 females and one male
- Proof of pregnancy: vaginal plug or sperm in vaginal smear referred to as day 0 of pregnancy

Duration of treatment / exposure:

days 6 through 15 of gestation

Frequency of treatment:

daily

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 1.5, 5, 15 mg/kg bw
Basis:
actual ingested

No. of animals per sex per dose:

20

Control animals:

yes, concurrent vehicle

other: positive control retinoic acid 7.5 mg/kg bw

Examinations

Maternal examinations:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily during the gestation period for pharmacodynamic signs or evidence of miscarriage

BODY WEIGHT: Yes
- Time schedule for examinations: Body weights were recorded on days 0, 6, 12, 15 and 20 of gestation.

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data


POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day: The female rats were sacrificed with chloroform and Cesarean sections performed on day 20 of gestation

Ovaries and uterine content:

The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: No data
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes

Fetal examinations:

- External examinations: Yes:
- sexed, examined for external abnormalities and weighted
- 1/3 examined for visceral absnormalites
- 2/3 examined for skeletal abnormalities

Historical control data:

no data

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

Maternal toxic effects:no effects

Details on maternal toxic effects:
No changes in behavior or appearance considered to be related to D & C Red #9 were observerd.
Increases in body weight were similar for control and treated rats.

Effect levels (maternal animals)

1

Dose descriptor:

NOAEL

Effect level:

15 mg/kg bw/day (actual dose received)

Based on:

test mat.

Basis for effect level:

other: maternal toxicity

2

Dose descriptor:

NOAEL

Effect level:

15 mg/kg bw/day (actual dose received)

Based on:

test mat.

Basis for effect level:

other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
No compound related effect upon any fetal parameters evaluated (number of alive and dead pups, mean body weight, sex, external, interaal and skeletal abnormalities)

Effect levels (fetuses)

Dose descriptor:

other:

Basis for effect level:

other:

Remarks on result:

not determinable

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified